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The portable Medela® Invia Motion negative pressure wound therapy (NPWT) system is indicated to create 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 exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts.

The Medela Invia Motion Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Motion NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The INVIA Motion is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.

Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Invia Motion NPWT pump is a single patient use pump for continuous or intermittent operation and has a lifetime of 60 days.

Invia Motion NPWT pump is portable and can be operated independent of the electrical Invia Motion power supply due to a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.

Invia Motion NPWT system is intended for use in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity.

The provided text describes the Medela AG Invia Motion Negative Pressure Wound Therapy System and its 510(k) summary. However, it does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria in a quantifiable manner as commonly expected for medical device evaluations that utilize AI or advanced diagnostics.

Instead, the non-clinical tests described focus on regulatory compliance, usability, and bench testing to demonstrate performance equivalence to predicate devices, rather than establishing direct clinical efficacy or performance against predefined, quantitative acceptance criteria via a clinical study with a specified sample size and ground truth.

Therefore, many sections of your requested output cannot be populated from the provided text. I will fill in what information is available and note when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Study (a form of test set):

  • Sample Size: 15 Healthcare Professionals (HCPs) and 15 patient Lay Users (LUs).
  • Data Provenance: Conducted in the United States. Prospective (evaluation of users interacting with the device).

• Bench Testing:

  • Sample Size: Not specified.
  • Data Provenance: Not specified (likely in-house lab testing).

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

• Usability Study: The "ground truth" for the usability study was the successful completion of tasks and the identification/resolution of use errors. This was observed and assessed by the study administrators/evaluators, whose qualifications are not specified.
• Bench Testing: The "ground truth" for bench testing would be the engineering specifications and performance characteristics of the predicate device for comparison. No experts in the sense of clinical decision-makers were involved in establishing this ground truth from the provided text.

4. Adjudication method for the test set

• Usability Study: The text implies direct observation and assessment of user performance against predefined tasks and safety criteria. There is no mention of independent adjudication or a consensus method (like 2+1 or 3+1) among multiple observers.

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 MRMC study was done. The device is a Negative Pressure Wound Therapy System, not an AI-assisted diagnostic or imaging interpretation device.

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

• This is not applicable as the device is a therapeutic system, not an algorithm, and is operated by a human user (HCP or lay user).

7. The type of ground truth used

• Usability Study: Expert observation/assessment of user task completion and safety during device operation.
• Bench Testing: Engineering specifications and performance data of the device itself, and comparative performance data from predicate devices in simulated wound environments.
• Clinical: No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Not applicable. The device is a therapeutic system, not a machine learning algorithm that requires a training set.

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

• Not applicable. (See point 8).

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AC Wound Management System is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Examples of appropriate wound types include: Diabetic/Neuropathic ulcers, Pressure ulcers, Chronic wounds, Acute wounds, Dehisced wound, Partial-thickness burns, and Flaps and Grafts.

The AC Wound Management System is a powered suction pump that utilizes a pump drive to generate light negative pressure. The pump drive is powered by a rechargeable battery. Optionally the unit can be connected to mains power using an included power converter. AC Wound Management System has a negative pressure setting range of -50 mmHg to -175 mmHg which is electronically monitored and controlled. The system includes a keyboard for user interface as well as audible and visual alarm indicators. The system includes a 300cc canister. The system can be set on a countertop, carried using a shoulder bag or mounted to an IV pole or bedside rail using the AC Wound Management System's mount. The AC Wound Management System includes the following three components: The pump drive, The waste canister, with its suction tube (the two are connected permanently), FDA cleared generic NPWT dressing, which will be distributed by NanoVibronix. The pump drive is a non-disposable unit which contains a motor, a battery and a user interface. The drive has a piston which protrudes the drive and reciprocates to activate the suction pump, which is integral to the canister. In the drive there is also a vacuum level monitor which monitors the vacuum at all times and maintains the required set therapy. The waste canister attaches to the drive. The pump creates vacuum within the waste canister for the purpose of suctioning exudates from the wound and collecting them in the canister. The canister has a hydrophobic filter. The suction tube connects the waste canister to the wound dressing applying the vacuum generated within the waste canister to the wound site. The tube also transfers the exudates from the wound to the waste canister by maintaining flow from the wound site towards the waste canister at all times.

Here's a breakdown of the acceptance criteria and study information for the AC Wound Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:

Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large.

Gauze Kits: Antimicrobial qauze wound filler, a Softport assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use.

The Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.

This submission describes the RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™, which adds a Softport assembly to existing Negative Pressure Wound Therapy (NPWT) dressing kits. The evaluation focuses on demonstrating that the new Softport assembly maintains the safety and effectiveness of the previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on functional performance and biocompatibility of the new Softport component, ensuring it performs comparably to the predicate device and does not introduce new risks.

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

The document does not explicitly state the sample sizes for the "verification and validation tests" conducted for the Softport. It mentions that these tests were performed to ensure performance requirements were met.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of the tests (functional and biocompatibility), they are typically conducted in a controlled laboratory or testing environment.

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

No information is provided regarding the use of "experts" to establish ground truth for this device's testing. The ground truth for functional performance is established by engineering specifications and objective measurements against those specifications. For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993) and the results of laboratory tests.

4. Adjudication Method for the Test Set

No adjudication method for a "test set" is mentioned, as the testing described is primarily objective performance and safety testing, not human-read evaluation.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a critical component. This submission is for wound dressing kits, and the testing focuses on the functional performance and biocompatibility of the device itself.

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

Yes, the described testing is akin to standalone performance. The verification and validation tests evaluate the physical device's ability to meet its functional specifications and biocompatibility requirements independently, without human interaction as part of the evaluated performance metric.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Engineering Specifications and Performance Standards: For functional aspects (negative pressure transmission, exudate collection, leak path control, 72-hour functionality, and performance under compression).
• International Biocompatibility Standards: Specifically, ISO 10993 for Cytotoxicity, Skin Irritation, and Skin Sensitization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device, as it is a physical medical device (wound dressing kit) undergoing traditional engineering and biological compatibility testing, not an artificial intelligence/machine learning algorithm that requires training data.

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

As noted above, there is no training set for this type of medical device submission.

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The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.

The RENASYS™ EZ NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ is suitable for use in both a hospital and homecare setting.

RENASYS™ EZ is compatible with existing Smith & Nephew wound dressing kits currently on the market.

The provided information does not contain details about acceptance criteria or a specific study proving the device meets those criteria beyond general statements. The document is a 510(k) summary for the RENASYS™ EZ Negative Pressure Wound Therapy system, focusing on demonstrating substantial equivalence to predicate devices.

Here's what can be extracted and what is missing based on your request:

Missing Information: Most of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. This type of detail is typically found in the full 510(k) submission, not the summary.

Here's a breakdown of the available information:

• Device: RENASYS™ EZ Negative Pressure Wound Therapy (NPWT) system.
• Purpose of the K091470 submission: To demonstrate substantial equivalence to previously cleared predicate devices (RENASYS™ EZ NPWT System K082426 and RENASYS™ GO NPWT System K083375).
• Method for demonstrating substantial equivalence: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use."

What we know about the "study":

The document states: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was conducted, but it does not describe the specific study methodologies, acceptance criteria, or results in detail. The testing was likely designed to show that the new device performs comparably to the predicate devices in terms of its core functionality (creating negative pressure, removing fluids).

Based on the provided text, I cannot complete most of the requested table and sections.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of a negative pressure wound therapy device, the "test set" would likely refer to physical device testing rather than a clinical dataset of patients.

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

• Number of Experts: Not applicable/Not specified. For a device like this, the "ground truth" would likely be based on engineering specifications and direct measurement against those specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

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

• MRMC Study: No, this is highly unlikely for a negative pressure wound therapy device. MRMC studies are typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a therapeutic device.

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

• Standalone Performance: Not applicable. This device is not an AI algorithm. Its performance is inherent to its mechanical and electronic function.

7. The type of ground truth used

• Type of Ground Truth: Likely engineering specifications and direct physical measurements (e.g., pressure gauges, flow meters). The document only broadly mentions "Performance testing."

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/machine learning device that would require a 'training set.'

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

• Ground Truth Establishment: Not applicable.

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