Search Results

The Invia® Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Integrated Dressing is appropriate for the following indications:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Integrated Dressing is a sterile NPWT dressing, consisting of: a pad area designed to evenly distribute the negative pressure and to draw off the exudate, a perforated silicone adhesive wound contact layer to provide a gentle but secure adhesion to the skin, and a double lumen tubing with Quick-connector to connect the dressing to the Invia NPWT pumps.

The Invia Integrated Dressing is available in three different sizes as shown below.

The Invia Integrated Dressing is designed to be compatible with the Invia Negative Pressure Wound Therapy Systems (Invia® Liberty NPWT suction pump, cleared via K142626 and K172145) and Invia® Motion (cleared via K161128 and K172145) and Invia® Ease suction pumps (K214112).

For wounds greater than 0.5 cm in depth, it is likely that a wound filler needs to be used with the Invia Integrated Dressing to ensure adequate treatment of all the wound surfaces. The Invia Integrated Dressing can be used with the wound filler accessory, Invia Black Foam NPWT. The Invia Black Foam NPWT is available in one size as shown below.

The provided text is a 510(k) summary for the Medela AG Invia® Integrated Dressing, a negative pressure wound therapy (NPWT) dressing. This document establishes that no clinical studies were required or performed for the substantial equivalence determination of this device. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance, including details like sample size, expert qualifications, and adjudication methods, cannot be fully answered from this regulatory document.

Specifically:

• No clinical studies were conducted to prove device performance or establish acceptance criteria related to a specific clinical outcome. The acceptance criteria are based on non-clinical (bench, human factors, and animal) testing and similarity to a predicate device.

Here's what can be extracted and inferred from the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted, direct "reported device performance" against clinical acceptance criteria is not available in the provided text. The performance reported below is from non-clinical studies demonstrating equivalence to the predicate device and compliance with safety standards.

Information Not Available (or not applicable due to lack of clinical study):

2. Sample size used for the test set and the data provenance: Not applicable for clinical performance as no clinical test set was used for proving efficacy. Non-clinical studies would have their own sample sizes (e.g., number of animals for animal testing, number of participants for human factors, etc.), but these details are not provided in the summary beyond mentioning that studies were conducted. Data provenance for non-clinical tests is typical manufacturing/testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an NPWT dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
7. The type of ground truth used: For the non-clinical animal study, the ground truth was animal tissue observation (macroscopic and histopathological findings) for adverse reactions due to prolonged dressing application. For other non-clinical tests, it was compliance with specifications and standards.
8. The sample size for the training set: Not applicable as no machine learning/AI model was developed.
9. How the ground truth for the training set was established: Not applicable.

In summary, the K223388 submission relies entirely on non-clinical testing to demonstrate that the Invia® Integrated Dressing is substantially equivalent to existing predicate devices and meets safety and performance requirements without introducing new questions of safety or effectiveness.

Ask a specific question about this device

The Invia Ease Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudates and infectious material. When used on closed surgical incisions, the Invia Ease NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy (NPWT).

The Invia Ease NPWT system is intended for use in acute, extended and home care settings.

The Invia Ease NPWT system is appropriate for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy (NPWT). The Invia Ease pump is reusable and portable pump intended to be used in acute, extended and home care settings.

The Invia Ease pump provides adjustable negative pressure with constant and intermittent therapy modes. Invia Ease NPWT System comprises the Invia Ease pump and the following accessories: Invia Ease canisters with integrated tubing, Invia Ease carrying case, Invia Ease handle, Invia Ease IV pole/ bed holder, and Invia Ease charger US.

The Invia Ease user interface includes two tactile buttons: an on/off button on the side of the pump and a mute button on the top of the pump. The pump is also equipped with a large touchscreen display on top of the pump, a status indicator bar on the front-side of the pump, which wraps around the side of the pump, as well as a charging port below the on/off button. Optical status of the pump is provided on the touchscreen and acoustic notifications are also used.

The pump is used with 300 ml, 500 ml and 1000 ml canisters that include a release button and canister tubing with Quick-Connector. The pump is compatible with Invia dressings (NPWT dressings from Medela AG) that interface via the Quick-Connector.

Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System. It details the device, its intended use, comparison to a predicate device, and summaries of non-clinical tests.

However, this document does not contain information about the acceptance criteria or a study proving the device meets clinical acceptance criteria. The document explicitly states under "Summary of Clinical Tests" that "Clinical testing was not needed to support substantial equivalence."

Instead, the document focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device. For devices like NPWT systems, "performance" is often assessed through engineering and bench testing rather than clinical trials for 510(k) clearance, unless there are significant technological differences or new indications for use that warrant clinical data.

Therefore, I can provide the following based on the document's content, focusing on non-clinical performance and "acceptance criteria" as defined by engineering standards and regulatory requirements for substantial equivalence:

Acceptance Criteria and Study for Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112)

Based on the provided FDA 510(k) summary, the "acceptance criteria" are primarily defined by compliance with recognized engineering standards, biocompatibility, cybersecurity, usability, and functional performance benchmarks demonstrated through non-clinical testing, ensuring the device is substantially equivalent to its predicate. No clinical performance acceptance criteria or clinical studies are detailed, as they were not required for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document lists various non-clinical tests performed to demonstrate safety and effectiveness. The acceptance criteria are implicit in passing these tests and meeting the standards. "Reported device performance" implies the device successfully passed these tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated in terms of individual units tested, but the document refers to various bench tests. For biocompatibility, testing was performed on "Canister" and "Tubing" components. For performance, it mentions "all Medela AG cleared dressing kits." Without specific numbers, it is assumed standard engineering and quality control sample sizes were used to establish statistical confidence in meeting acceptance criteria during manufacturing and validation.
• Data Provenance: The tests are explicitly non-clinical bench tests performed by Medela AG, a company based in Switzerland. The data would originate from their internal testing and validation processes. Given the nature of 510(k) non-clinical submissions, this data is inherently prospective in the sense that it was generated specifically for the regulatory submission to prove design and manufacturing parameters.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable as the document explicitly states, "Clinical testing was not needed to support substantial equivalence." Therefore, there was no test set requiring expert ground truth for clinical outcomes or diagnoses, as would be the case for AI/imaging devices. The "ground truth" for non-clinical tests is against engineering specifications and international standards which are established by consensus in their respective fields (e.g., electrical engineers for IEC 60601, toxicologists for ISO 10993).

4. Adjudication Method for the Test Set:

• None. As the study described is non-clinical bench testing to engineering specifications, there is no need for adjudication of human interpretation, which is typical for clinical studies involving multiple readers or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study is a clinical study format typically used for diagnostic devices (e.g., radiology AI). This device (Negative Pressure Wound Therapy System) is a treatment device, and no clinical studies were performed or required for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which operate either independently or with human interaction (e.g., adjusting pressure). The performance is evaluated based on its functional output (e.g., vacuum pressure, alarm accuracy) rather than a diagnostic output.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is established by:
  • Engineering Specifications: Designed performance parameters (e.g., vacuum levels, battery life, dimensions).
  • International Standards: Published consensus standards for medical devices (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility, ISO 14971 for risk management).
  • Predicate Device Performance: Demonstrating substantial equivalence to the legally marketed predicate device (K172145) provides a comparative "truth" that the new device performs similarly in its core functions.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" in device development refers to design iterations, and the "set" would be the prototypes and components tested during the design process. No specific "training set" is relevant for this type of regulatory submission.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. (See point 8). The "ground truth" for the device's design and manufacturing is established through adherence to Good Manufacturing Practices (GMP), design controls, and iterative testing against engineering requirements and established safety/performance standards.

Ask a specific question about this device

The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Freestyle Flex™ breast pump is intended for a single user.

The breast pump is intended to be used in a home environment.

The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.

The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).

The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.

The Freestyle Flex ™ breast pump provides the following user features:

• . Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
• 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
  • o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
• o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
• "Let-down" control to change between stimulation phase and expression phase. .
• Option of either single or double breast pumping. .

This document is a 510(k) Summary for the Medela Freestyle Flex™ breast pump and focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle® Breast Pump K150499) rather than presenting a study to prove performance against specific acceptance criteria in the traditional sense of clinical performance measures (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Therefore, some of the requested information regarding acceptance criteria and study design (especially related to expert ground truth, adjudication, MRMC, and standalone performance metrics) is not applicable or cannot be directly extracted from this type of regulatory submission for a powered breast pump. This submission is primarily concerned with safety and effectiveness through technological comparison and conformance to standards.

However, I can extract information related to the technical specifications and non-clinical testing performed to support the substantial equivalence claim.

Here's the closest representation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a breast pump, "acceptance criteria" primarily revolve around meeting technical specifications for functionality, safety standards, and equivalence to a predicate device. The "reported device performance" refers to the device adhering to these specifications during testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not specify a "test set" in the context of clinical data. The performance claims are based on non-clinical bench testing. Therefore, sample sizes for human subjects or data provenance (country/retrospective/prospective) are not applicable or provided here. The tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth from experts is not a concept used in this type of non-clinical bench testing for a breast pump. Performance is measured against predefined engineering specifications and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant for a breast pump's regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to bench testing of the pump's physical and electrical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests are the engineering specifications and established international safety and performance standards for powered breast pumps and electrical medical equipment. For example, a vacuum level output of -245 mmHg is measured directly against a known standard.

8. The sample size for the training set

Not applicable. This device does not use machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Invia Liberty NPWT System.

The Invia Abdominal Dressing Kit consists of an Organ Contact Layer (OCL), two foam pads, four transparent films and a suction interface (Invia FitPad).

• -The OCL is an oval polyurethane film with fenestrations intended to protect the abdominal content and enable fluid drainage from the abdomen.
• -The foam pad is an oval hydrophobic polyurethane foam with open cell structure intended to be placed over the OCL in order to distribute the negative pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
• -The transparent film is a thin transparent polyurethane film with acrylic adhesive intended to fixate the wound filler and seal tight to the skin.
• The Invia FitPad is intended to distribute negative pressure to the wound and transport exudates from the abdominal cavity to the canister of the Invia Liberty Negative Pressure Wound Therapy (NPWT) pump.
  The components of the Invia Abdominal Dressing Kit are packaged sterile and are for single use only.

The provided document is a 510(k) summary for the Medela AG Invia Abdominal Dressing Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, a standalone study, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is largely not directly applicable or available in this document. This submission relies heavily on non-clinical tests to show that the new device performs similarly to its predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical outcome. Instead, it demonstrates performance equivalence through non-clinical testing by comparing the Invia Abdominal Dressing Kit to its predicate. The "acceptance" can be inferred as successfully demonstrating equivalent functionality in laboratory settings.

2. Sample Size for Test Set and Data Provenance:

• Non-clinical Performance Testing (Wound Model): The document mentions "a wound model, simulated wound exudates, and multiple pressure sensors." It also states "Multiple vacuum settings over 30 minutes and 73 hours were used." However, a specific numerical sample size (e.g., number of test runs, number of models) is not provided. The provenance is laboratory testing.
• Human Factors Validation Testing: "15 surgeons" were used. The provenance is internal usability testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Usability Experts: "Three usability experts" conducted heuristic evaluations. No specific qualifications beyond "usability experts" are provided in the document.
• Surgeons for Human Factors Validation: "15 surgeons with experience operating on open abdomens" were used. This indicates relevant expertise for the device's intended use. No further detailed qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set:

• There is no mention of an adjudication method in the context of the non-clinical or human factors testing. These were primarily performance-based or observation-based assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Abdominal Dressing Kit to its predicate device." This type of study focuses on device performance in a laboratory setting compared to a predicate, not how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This question is not applicable. The Invia Abdominal Dressing Kit is a physical medical device (dressing kit for negative pressure wound therapy), not an AI algorithm. Its performance is inherent to its physical properties and interaction with the NPWT system, not an algorithm.

7. Type of Ground Truth Used:

• Non-clinical Performance Testing: The "ground truth" was established by physical measurements and simulated conditions within a controlled laboratory wound model, using established scientific principles and comparison to a legally marketed predicate device under identical test conditions.
• Human Factors Validation: The "ground truth" was established by observing user performance (surgeons) against predefined usability scenarios and identifying errors or successful task completion.

8. Sample Size for the Training Set:

• This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established:

• This question is not applicable as there is no training set.

In summary:

This 510(k) submission primarily relies on non-clinical (laboratory) performance testing and human factors validation (usability) to demonstrate substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. The "acceptance criteria" are therefore implicit in the successful demonstration that the device performs functionally and safely at least as well as the predicate in relevant non-clinical and simulated use environments.

Ask a specific question about this device

The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia White Foam is appropriate for use for the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts

The Invia White Foam is a single packed, sterile, polyvinyl alcohol (PVA) foam intended for use in conjunction with the previously cleared Invia Foam Dressing Kit with FitPad (K170088), Invia Motion (K161128) and Invia Liberty (K142626) negative pressure wound therapy (NPWT) systems. It is a stand-alone wound dressing used as an alternative or as a supplement to the wound dressing in the Invia Foam Dressing Kit with FitPad. The Invia White Foam is available in two sizes (small, large). The Invia White Foam is for use by healthcare professionals in acute, extended and home care settings.

The Invia White Foam NPWT is an open cell, hydrophilic, PVA foam moistened in sterile water. Like other NPWT foams, the Invia White Foam NPWT is an effective wound dressing, allowing a controlled application of sub-atmospheric pressure to the local wound environment to remove wound exudate. The Invia White Foam NPWT allows the passage of fluid through the foam and away from the wound bed. The foam can be used with both constant and intermittent NPWT delivery. It is able to be cut to size to suit a particular wound size.

This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Invia White Foam NPWT". It outlines the device's characteristics, intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required.

Therefore, many of the requested details about acceptance criteria, study sample size, expert involvement, and ground truth establishment for a human-AI comparative study or standalone algorithm performance are not applicable to this document. This submission did not involve a study for an AI-powered diagnostic device, but rather a negative pressure wound therapy (NPWT) foam.

However, I can extract the information related to the acceptance criteria and performance of this non-AI device from the "Summary of Non-Clinical Tests" section.

Here's a breakdown of the requested information, indicating where it's not applicable (N/A) for this specific FDA submission:

1. A table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL TESTS" section, the device's performance was evaluated against established standards and predicate device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This refers to the number of physical devices or samples tested in the non-clinical studies (e.g., how many foam samples for biocompatibility, how many units for sterilization testing, how many test runs in the wound model). The document does not specify the exact number of samples tested for each non-clinical evaluation (e.g., "The Invia White Foam was tested..." rather than "100 samples of the Invia White Foam were tested...").
• Data Provenance: The document does not specify the country of origin for the data or whether the non-clinical studies were prospective or retrospective. These types of studies are inherently prospective as they involve conducting new tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This device is a negative pressure wound therapy foam, not an AI-powered diagnostic device that requires expert review for "ground truth" establishment in a clinical setting. The "ground truth" for its performance is based on engineering and materials science principles and direct measurement of physical properties (e.g., pressure, fluid removal).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. As above, this is not an AI diagnostic study requiring multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI diagnostic device. No human-in-the-loop studies or MRMC studies were conducted. The non-clinical studies focused on the performance of the device itself and its equivalence to predicate devices, not on human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI algorithm. Its "standalone performance" refers to its physical and functional properties, as described in the table above, not an algorithmic output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by:

• Adherence to recognized standards (e.g., ISO-10993 for biocompatibility).
• Direct measurement against physical and functional specifications (e.g., achieving constant vacuum, efficient fluid removal).
• Comparative performance against a legally marketed predicate device in a wound model.

8. The sample size for the training set

N/A. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

N/A. As above, this is not an AI device, so there is no training set or ground truth establishment in that context.

Ask a specific question about this device

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Motion NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Liberty NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Gauze Dressing Kit with FitPad in comunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The labeling of the Invia Motion Negative Pressure Wound Therapy (NPWT) System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad has been modified to expand the indications for use to include closed surgical incisions. When used on closed surgical incisions, the devices are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

INVIA MOTION NPWT SYSTEM
The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Motion suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.

INVIA LIBERTY NPWT SYSTEM
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.
A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.

INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD
The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.

This document describes the premarket notification for the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems, and their associated Foam and Gauze Dressing Kits with FitPad. The submission seeks to expand the indications for use to include closed surgical incisions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" with numerical targets and corresponding device performance values in a typical format for a medical device study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implied by demonstrating substantial equivalence to predicate devices for the new expanded indication (closed surgical incisions) and by successful completion of various non-clinical performance and safety tests.

The "reported device performance" is described qualitatively through these tests.

Implied Acceptance Criteria and Reported Device Performance:

• A steady rise of negative pressure at test onset to the set vacuum level.
• A uniform and constant vacuum level throughout the test period.
• The vacuum level corresponds to the selected set vacuum level of the pump.
• The volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister.
• Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model.
• Compared equivalently to the predicate ActiV.A.C. Therapy Unit (K120033) for use on closed surgical incisions. |
  | Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices for the expanded indication. | The non-clinical tests described demonstrate that the device is substantially equivalent to the predicate devices for the new indication of closed surgical incisions. The differences do not introduce new intended uses or raise different questions of safety and effectiveness. |
  | Functional Equivalence: Non-significant changes to components (software, hardware, labeling, sterile packaging) maintain performance. | Software verification and validation testing were completed for non-significant changes. |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical performance testing using simulated wound models.

• Sample size: Not explicitly stated as a numerical count of "cases" or "patients." Performance testing was conducted on "a closed surgical incision model and simulated wound exudates." The typical approach for such tests involves a sufficient number of runs or samples to demonstrate consistent performance within the system. Specific sample sizes for individual tests (e.g., bioburden, materials testing) are not detailed.
• Data Provenance: The studies are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human patients. Therefore, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply. The submitter is Medela AG, based in Baar Zug, Switzerland, implying the tests were likely conducted under their quality system, possibly internally or at contract labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is a non-clinical submission, and no ground truth established by medical experts (like radiologists) is relevant or mentioned. The "ground truth" for the performance testing cited would be engineering specifications and validated test methods to measure parameters like pressure, flow, and fluid removal accuracy against established standards and predicate device performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As a non-clinical performance study using simulated models, there is no need for adjudication by human experts as would be required for clinical image interpretation or diagnostic performance studies. The "results" are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The submission is for Negative Pressure Wound Therapy (NPWT) systems and dressings, which are physical medical devices, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its mechanical and functional design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the "ground truth" is based on:

• Engineering Specifications: The device's predetermined operational parameters (e.g., set vacuum levels, flow rates).
• Validated Test Methods: Standardized procedures for measuring device performance (e.g., pressure output, fluid removal volume).
• Predicate Device Performance: Direct comparison to the established performance characteristics of the legally marketed predicate devices (ActiV.A.C. Therapy Unit K120033).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that uses training sets.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Ask a specific question about this device

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Foam Dressing Kit with FitPad is appropriate for use on the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts

Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad are to be used only with the approved therapy units.

Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and Grafts

INVIA FOAM DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a foam, a suction interface (Invia FitPad) and transparent film (one or more pieces depending on the kit size). The foam is manufactured using a reticulate flexible polyether and polyurethane hydrophobic material, with a high tensile strength (20 PSI*) and charcoal color. The FitPad suction interface features a quick connecting interface to the canister tubing for easy and secure connection. The transparent film is designed with self-explanatory markings to facilitate the ease of use.

INVIA GAUZE DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a gauze pad, one or two transparent films (depending on the kit size), a suction interface (Invia FitPad), and saline.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Invia Dressing Kits with FitPad:

This document primarily describes non-clinical and one specific clinical test related to the Invia Foam Dressing Kits with FitPad and Invia Gauze Dressing Kits with FitPad. It is a 510(k) summary for premarket notification, aiming to establish substantial equivalence to predicate devices, rather than a detailed report of a clinical trial proving specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in the context of this traditional medical device submission.

However, I can extract the acceptance criteria and study information that are present.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria with corresponding reported device performance values in the way one would expect for an AI/ML device (e.g., "sensitivity > 90%"). Instead, it lists compliance with established standards and general performance characteristics demonstrated.

Missing Information and Not Applicable Categories for this Device Type:

2. Sample size used for the test set and the data provenance: Not specified in this document for the non-clinical tests. For the clinical skin irritation study, the sample size is not stated, nor is the data provenance beyond "a clinical study was conducted". This is not a study on an AI/ML algorithm or diagnostic device with a "test set" in the common sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests (biocompatibility, sterilization, pressure maintenance) is established through standardized laboratory analyses and measurements, not expert consensus on images or medical records.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the types of tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an NPWT dressing kit, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • For biocompatibility: In vitro and in vivo models according to ISO 10993 series.
   • For sterilization: Microbiological tests (e.g., sterility assurance level verification).
   • For pressure performance: Engineering measurements and functional testing.
   • For skin irritation: Clinical observation and assessment as per ISO 10993-10 Annex C.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia Motion NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts

The Invia Motion Negative Pressure Wound Therapy (NPWT) system is available in six versions with different run times:

• 7 Days
• 15 Days
• 30 Days
• 60 Days
• 120 Days
• Endure: lasts for one patients entire therapy, max. 3 years

The Invia Motion Negative Pressure Wound Therapy system is comprised of the Invia Motion pump, Invia Motion Canister/Tubing Set 0.15l, Invia Motion Power Supply and Invia Motion Carrying Case. Additionally, several separately cleared accessories and kits are compatible with the Invia Motion NPWT System.

The Invia Motion pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling. The Invia Motion NPWT pump provides treatment status through a display and acoustic signals. It is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.

This document is a 510(k) Premarket Notification from Medela AG for their Invia Motion Negative Pressure Wound Therapy System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices, not to prove the device's efficacy through new clinical studies. Therefore, the information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device (such as performance metrics, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in this document.

This submission focuses on engineering, non-clinical, and usability testing to show that the new version of the device, despite some changes (like a new canister/tubing set and improved blockage detection), performs equivalently and safely to its predecessors.

Here's a breakdown of what can be extracted based on the provided document, and what cannot be answered as it's not relevant to a 510(k) for this type of device:

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical/electromechanical device and not an AI/ML one, the acceptance criteria are based on functional performance, electrical safety, usability, and biocompatibility, rather than diagnostic accuracy metrics. The document summarizes the tests performed and states they were successful in demonstrating intended performance. Specific numerical "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not applicable or provided here.

2. Sample size used for the test set and the data provenance

Not applicable in the context of an AI/ML test set for diagnostic accuracy. The "test set" here refers to physical tests on the device and its components (e.g., specific wound models for performance, various environmental conditions for electrical safety). The provenance is from Medela AG's internal R&D and external testing laboratories. These are non-clinical bench tests, not data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of this device refers to physical properties and functional accuracy (e.g., actual vacuum pressure, correct fluid flow, sterility). These are established by engineering standards and measurement, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth for image interpretation or diagnosis. This document pertains to device functionality and safety.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, and no clinical studies (including MRMC studies) were required or performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Motion Negative Pressure Wound Therapy System to its predicate device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm with diagnostic performance or human-in-the-loop interaction for diagnosis. Its "performance" is its ability to generate negative pressure, collect exudate, and alert to issues.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering and medical device standards, physical measurements, and simulated physiological conditions. Examples include:

• Physical measurements: Verification of vacuum levels, fluid volume dispensed/removed, motor runtime.
• Standards compliance: e.g., IEC 60601 series for electrical safety, ISO 14971 for risk management, ISO 11135-1 for sterilization, ISO 10993-1 for biocompatibility.
• Simulated environments: Use of "wound models and simulated wound exudates" to test pressure delivery, leakage, and blockage detection.

8. The sample size for the training set

Not applicable. There is no AI/ML component requiring a training set for diagnostic or predictive purposes.

9. How the ground truth for the training set was established

Not applicable. See #8.

Ask a specific question about this device

The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bed-side.

Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.

The Medela Vario 8/18/ci suction pump is an AC or AC/DC-powered aspirator and incorporates in its medium sized housing a motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHg, a membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.

With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.

The Models Vario 18 "high vacuum" suction pump have a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHg). The pump is marked "low flow high vacuum".

The Model Vario 18 c/i "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -55 kPa (-375 mmHg). The pump is marked "low flow medium vacuum".

The Models Vario 8 "low vacuum" suction pump have a suction capacity of 8 liters per minute and a maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".

A variety of reusable and disposable accessories are available.

This document describes the FDA's acceptance of the Medela Vario 8/18/ci Suction Pump. As such, it details testing and compliance with various standards but does not include a comparative study with a test set, ground truth established by experts, or any elements that involve analyzing performance against a specific set of criteria where the "device performance" would be distinct from simply meeting regulatory standards.

Therefore, many of the requested sections (2-8) cannot be answered from the provided text. The document focuses on showing substantial equivalence to a predicate device rather than a standalone performance study as would be seen for AI/ML devices or novel therapies.

Here's a summary of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating compliance with recognized voluntary standards and showing that the device's technical characteristics are substantially equivalent to a predicate device, with expanded specifications supported by testing. The "reported device performance" is essentially that the device met these standards and specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The testing described is primarily engineering and bench testing against standards and specifications, not clinical data with a "test set" in the context of device performance on patients or specific cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. "Ground truth" established by experts is typically for clinical data assessment (e.g., image interpretation, diagnosis), which was not part of this submission as per section 10 ("SUMMARY OF CLINICAL TESTS: Clinical testing was not required...").

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there was no test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered suction pump and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

"Standalone" performance in this context refers to the device's ability to operate according to its specifications (e.g., flow, vacuum, battery life). The non-clinical tests described are indeed standalone tests of the device's physical and functional performance. It is not a standalone algorithmic performance as might be seen for an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests was established by published voluntary standards (e.g., ISO, IEC, EN ISO) for safety and performance, as well as the manufacturer's own internal specifications which were validated against the predicate device. There was no expert consensus, pathology, or outcomes data used to establish ground truth in this context.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product and does not involve a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

The Symphony breast pump is intended to be used by lactating women to express and collect milk from their breasts. The pumping can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Symphony breast pump is a multi-user breast pump and therefore, designed for a safe and hygienic use by different mothers. The Symphony breast pump employs a control knob for the user to adjust the applied vacuum. The suction patterns are programmed with either constant or variable cycles (pump speed). The Symphony breast pump is capable of providing vacuum levels from -50 to -250 mmHg with cycling rates up to 120 cycles per minute.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medela Symphony Breast Pump. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria against a clinical outcome. Therefore, some requested information, particularly around clinical acceptance criteria and related study details, may not be explicitly present or not applicable in the same way it would be for a novel device.

Acceptance Criteria and Device Performance for Medela Symphony Breast Pump (K151632)

The provided document (510(k) summary) focuses on demonstrating substantial equivalence of the Medela Symphony Breast Pump (current version) to a legally marketed predicate device (K020518). The "acceptance criteria" are primarily based on meeting the same performance specifications as the predicate device or demonstrating that modifications do not adversely affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance testing primarily to demonstrate physical and functional specifications.

• Sample Size for Performance Testing:
  • For testing with the Standard 2.0 program card: Six pumps were used (three with each of the two approved motor types).
  • For testing with the Preemie+ program card: One pump of each motor type was used (total of 2 pumps).
  • Additional tests (battery operation, varying input voltages, different breast shield sizes, single pumping) were conducted, but specific sample sizes for these sub-tests are not explicitly stated beyond implying they were performed on the tested pumps.
• Data Provenance: The tests are non-clinical, laboratory-based performance tests, likely conducted at the manufacturer's facilities in Switzerland (Medela AG is based in Baar, Switzerland). The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate compliance with specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) summary for a powered breast pump. The "ground truth" for the performance tests (e.g., vacuum levels, cycle rates, battery life) is established by direct measurement against engineering specifications and industry standards, not by expert consensus or interpretation of complex medical imagery/data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for diagnostic devices where human reader interpretations are being assessed against a consensus ground truth. For performance testing of a physical device like a breast pump, measurements are objective and directly compared to specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Symphony breast pump to its predicate device." Therefore, there is no mention of human readers, AI assistance, or effect size improvements related to such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to this device. The Medela Symphony Breast Pump is a mechanical device with integrated software for controlling its operation (e.g., 2-Phase Expression, Preemie+ program). It does not involve "algorithms only" or "AI" in the sense of a standalone diagnostic or predictive algorithm being evaluated independently. The software is integral to the device's function, and its performance is assessed as part of the overall device performance (e.g., ensuring correct vacuum and cycle rates as programmed).

7. The Type of Ground Truth Used

The "ground truth" for the device's technical performance is based on:

• Engineering Specifications: Defined vacuum ranges, cycle speeds, and battery life.
• Voluntary Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home use safety (IEC 60601-1-11), and suction equipment performance (EN ISO 10079-1).
• Regulatory Guidance: Adherence to FDA guidance for sterility, biocompatibility, and software validation.

8. The Sample Size for the Training Set

This information is not applicable. The Medela Symphony Breast Pump is a traditional electromechanical medical device. It does not use "training sets" in the context of machine learning or artificial intelligence. Its software is programmed based on predefined algorithms and fixed parameters and validated through traditional software verification and validation, not through learning from data like an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device