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The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.

The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).

This document is a 510(k) summary for a Nasal Pillow Mask, indicating that the device is substantially equivalent to a previously cleared predicate device. As such, it highlights the lack of a new study to demonstrate acceptance criteria because the device is deemed identical to its predicate in all relevant aspects.

Here's the breakdown of why the requested information cannot be fully provided based solely on the input, and what can be extracted:

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

The document explicitly states: "The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Therefore, no new non-clinical testing is required."

This means that for the current 510(k) submission (K243225), no new acceptance criteria or reported device performance data was generated or provided for the subject device. The acceptance criteria and performance data would have been established and demonstrated for the predicate device (K120920) in its original submission.

The table in the document provides specifications for Deadspace Volume, Resistance, Therapy pressure, Noise level, Environmental Conditions, Weight, and Size Flow, which are common technical specifications for such devices. These are not explicitly stated as "acceptance criteria" but rather as "Specifications" that are "Same" as the predicate.

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The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

· The Genadyne DUO NPWT System, in the absence of instillation is intended 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 exudate and infectious material. • Instillation therapy is indicated for patients who would benefit from vacuum assisted drainery of topical wound treatment solutions and suspensions over the wound bed.

The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The Genadyne DUO NPWT is a Negative Pressure Wound Therapy unit with instillation option. The DUO NPWT features an interface touch panel which provides user selectable therapy modes (continuous mode and variable mode) and multi pressure options from 40 m m H g to 200 mmHg). The DUO NPWT is packaged in a box that includes a universal charger, power cable, a user manual and a user carry bag. The dressing kits includes the transparent film dressings, the Genadyne foam dressing and the Genadyne Port. The DUO NPWT is designed to be used with a canister collection system. The canister will have 3 sizes available (600cc, 800cc and 1100cc). All the dressings and canisters are single use disposable items. To help ensure safe and effective use, the DUO NPWT are to be used only with the Genadyne supplied dressings and canisters. There is an instillation option on the device for instillation therapy for the patient that requires it. The installation option provides a controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The instill mode consists of NPWT combined with the automatic, controlled delivery and removal of wound treatment solutions to and from the wound bed. It offers a more conducive dressing environment for wound bed management with adjustable target pressure, vacuum time, instill volume, and soaking time. With the adjustable target pressure, negative pressure in mmHg is applied to the wound.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Genadyne DUO NPWT), but it does not include details about acceptance criteria, specific study results proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily focuses on:

• Device Description and Indications for Use: What the device is and what it's used for.
• Substantial Equivalence: How the device is similar to a legally marketed predicate device.
• Regulatory Compliance: Information about general controls, quality system regulations, UDI, and adverse event reporting.
• Non-clinical Testing: Mentions that bench tests were performed per ISO10079-1 to show the device functions appropriately, including "Pressure precision test, absorption test, alert capacity test, instill therapy test." It also mentions software documentation and a "Moderate" level of concern for software.

It does not provide the quantitative results or the methodology of these tests in detail, nor does it define acceptance criteria for these tests or relate them to clinical performance metrics. The information needed for a detailed description of acceptance criteria and the study proving performance (as outlined in your request) is simply not present in the provided text.

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Genadyne Hybrid Foam Dressings when used in conjunction with the XLR8+, UNO30 and UNO Plus NPWT System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The Genadyne Hybrid foam dressings are designed to be used with the Genadyne XLR8+ NPWT (K143726), UNO30 (K190028) and UNO Plus (K210107). The dressing has a layer of silicone that will be placed as a contact layer to the patients wound. All the dressings are single use disposable items. To help ensure safe and effective use, the Genadyne Hybrid foam dressings are to be used only with the Genadyne supplied devices. The decision to use clean versus sterile/aseptic technique for wound cleaning is dependent upon wound pathophysiology, physician/clinician preference, and institutional protocol.

This document is an FDA 510(k) clearance letter for a medical device called "Genadyne Hybrid Foam Dressings." It does not contain any information about an AI/ML device or a study proving its performance against acceptance criteria.

The information provided describes a dressing used in Negative Pressure Wound Therapy (NPWT) and compares it to a predicate device. The review focuses on the device's technological characteristics and intended use, asserting substantial equivalence based on bench testing of the dressings' function with existing NPWT systems.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text doesn't concern such a device.

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Genadyne UNO Negative Pressure Wound Therapy System is in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed Surgical Incision
  Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.

The Genadyne UNO Negative Pressure Wound Therapy System is a single patient use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO Negative Pressure Wound Therapy System has a pre-determined lifespan. The unit has an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and has selections of Continuous Mode at 80mmHg/ 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Negative Pressure Wound Therapy System Therapy Kits include a therapy unit. 200 ml and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System.

This document is a 510(k) Summary for the Genadyne UNO Negative Pressure Wound Therapy System, seeking FDA clearance for a modified version of an existing device (K190028). The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with detailed performance metrics. Instead, it relies on demonstrating compliance with recognized electrical safety and electromagnetic compatibility standards, and on a comparison of technical specifications with a legally marketed predicate device.

However, based on the non-clinical testing mentioned and the comparison table, we can infer the acceptance criteria are met by demonstrating conformity to relevant standards and maintaining equivalent performance to the predicate device for critical specifications.

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: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for performance. The testing involved compliance with IEC standards for electrical safety and EMC. These standards typically involve a defined set of tests on representative units of the device rather than a "sample size" in the statistical sense for clinical studies. The number of devices used for these engineering tests is not disclosed.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are described as "non-clinical" and implicitly prospective as they were performed on the new device model to demonstrate compliance.

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

This information is not applicable as the submission relies solely on non-clinical testing (electrical safety, EMC) and comparison to a predicate device's specifications. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes for this submission.

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

This information is not applicable as there was no clinical study with a test set requiring adjudication of findings. The assessment was based on engineering test results against established compliance standards.

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:

This information is not applicable. No MRMC comparative effectiveness study was performed as this is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic imaging device. The changes relate to the pump's power source and housing, not its interaction with clinical interpretation.

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

This information is not applicable. This device is a Negative Pressure Wound Therapy System, which is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.

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

The concept of "ground truth" as typically understood in the context of diagnostic AI or clinical studies (e.g., pathology, expert consensus) is not applicable to this submission. The "ground truth" for the non-clinical tests would be the established requirements and limits defined by the IEC 60601-1 and IEC 60601-1-2 standards. The device's performance (e.g., maintaining 125 mmHg vacuum) is directly measured and compared against its own specifications and the predicate device's specifications.

8. The sample size for the training set:

This information is not applicable. This device is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set."

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

This information is not applicable for the reasons stated in point 8.

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. Genadyne UNO is a single patient use device.

The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and study information for the Genadyne UNO Negative Pressure Wound Therapy System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for performance tests in a tabular format with corresponding reported values. Instead, it states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, based on the non-clinical testing discussion, we can infer the types of performance aspects tested.

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

The document mentions "A clinical case series from 15 patients with closed surgical incisions were provided as supplementary performance data in support of the safety of the device."

• Sample Size for Test Set: 15 patients
• Data Provenance: Not explicitly stated, but clinical case series generally imply prospective or retrospective data from a clinical setting.
  • Retrospective/Prospective: Not specified, but "case series" can be either.

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

This information is not provided in the document. The document refers to a "clinical case series" as "supplementary performance data," but it does not describe how the outcomes for these 15 patients were adjudicated or evaluated by experts to establish a 'ground truth' for device performance in the context of an AI/algorithm. This device is a physical pump, not an AI diagnostic tool, therefore, the concept of "ground truth" as typically applied to image analysis or diagnostic algorithms doesn't directly apply in the same way. The "ground truth" here would relate to the patient's actual wound healing and safety outcomes, which would likely have been determined by the treating clinicians.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As noted above, this isn't an AI diagnostic device where expert adjudication of outputs would typically be required. The "clinical case series" would involve patient follow-up and clinical assessment by healthcare professionals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation where multiple readers evaluate cases with and without AI assistance). The Genadyne UNO is a Negative Pressure Wound Therapy System, which is a therapeutic device, not a diagnostic one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Genadyne UNO is a physical medical device (a powered suction pump for wound therapy), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the clinical case series, the "ground truth" would be the clinical outcomes observed in the 15 patients regarding wound healing, removal of exudates/infectious material, and absence of adverse events associated with the device's use. This would be based on clinical assessment and patient follow-up by healthcare professionals. For the bench tests, the ground truth would be based on objective measurements of physical parameters (pressure, absorbance, alert function) against predefined engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As the Genadyne UNO is a physical medical device and not an AI/Machine Learning algorithm, there is no "training set." The device's performance is established through bench testing and clinical observations, not through a learning process from data.

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

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

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts

Genadyne UNO is a single patient use device.

The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Genadyne UNO Negative Pressure Wound Therapy System:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical trial. As such, detailed human clinical study data proving the device meets acceptance criteria in the same way a new drug or novel device might is not typically included in these summaries. The "acceptance criteria" here largely refer to comparison against the predicate device's characteristics and meeting relevant safety standards.

Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" for this 510(k) submission is demonstrating that the Genadyne UNO is substantially equivalent to the predicate device, the Pico Single Use Negative Pressure Wound Therapy System (K151436), and that it meets applicable safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The document primarily describes non-clinical testing to support substantial equivalence.

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

• Test Set Sample Size: Not specified for individual tests. For the non-clinical testing, sample sizes would typically refer to the number of units tested per bench test (e.g., n=3, n=5, n=10 devices). The document states "Bench testing was done with in house protocol to establish ensure the performance and outcome."
• Data Provenance: The testing appears to be prospective bench testing conducted in-house by Genadyne Biotechnologies, Inc., and potentially by third-party labs for standards compliance (e.g., biocompatibility, IEC). The country of origin for the data generation would likely be the USA, as this is a US-based company submitting to the FDA.

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

• This information is not provided in the document. For bench/non-clinical testing, "ground truth" is typically established by engineering specifications, recognized standards (e.g., ISO, IEC), and scientific principles, not by expert medical consensus on individual cases.

4. Adjudication method for the test set:

• This is not applicable to the type of non-clinical, bench testing described. Adjudication methods like 2+1 or 3+1 are used for reviewing patient cases, often in diagnostic studies to establish a consensus ground truth.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The Genadyne UNO is a therapeutic negative pressure wound therapy system, not a diagnostic imaging device with AI interpretation.

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

• No, this is not applicable. The Genadyne UNO is a medical device (a powered suction pump) used directly on patients for wound therapy, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is its functional operation (e.g., maintaining negative pressure, managing exudate).

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

• For the non-clinical testing described, the "ground truth" or reference standards used would be:
  • Engineering specifications for device function (e.g., vacuum pressure, battery life).
  • International standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility).
  • Predicate device characteristics as a benchmark for comparison.

8. The sample size for the training set:

• Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

Summary of Device Meeting Acceptance Criteria:

The document concludes that the Genadyne UNO meets its acceptance criteria by demonstrating substantial equivalence to the predicate device and by passing relevant safety and performance non-clinical tests.

• Biocompatibility Testing: The dressing kit (silicone foam dressing, PU film strips) met accepted criteria.
• Electrical Safety & EMC Testing: The pump successfully met acceptance criteria for all applicable IEC testing.
• Bench Testing: In-house protocols were used to ensure the device's performance and outcome were as expected.
• Design & Function Comparison: While some technical specifications differ (e.g., max vacuum, battery type, canister use), these differences are highlighted and determined not to raise new issues of safety or effectiveness. The fundamental intended use, indications, and contraindications are presented as similar to the predicate.

The basis for acceptance is that the device is as safe and effective as a legally marketed predicate device, as evidenced by these non-clinical comparisons and standard compliance.

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The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

The XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from the wound.

This document describes a 510(k) premarket notification for the Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.

Therefore, the typical metrics and study designs associated with proving a device meets specific acceptance criteria via a study (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) are not present in this document. The "acceptance criteria" here are primarily met by demonstrating comparable performance and characteristics to the predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device (A4-XLR8 Wound Vacuum System, K090638). The new device, XLR8 Plus, aims to be substantially equivalent. The table provided is a comparative table, not a pure acceptance criteria table with a "pass/fail" for an independent study.

Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: For the 510(k) process, the new device can be better than the predicate in some aspects (like suction capacity or additional canister size) as long as it doesn't raise new questions of safety or effectiveness.

2. Sample Size for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of an AI/ML device validating performance on a dataset of patient cases. The testing conducted for this device is focused on engineering verification and validation (e.g., measuring suction, power, verifying dimensions, and confirming compliance with electrical safety standards). These tests are typically performed on a small number of production or pre-production units.

• Sample Size: Not specified in terms of patient data or clinical cases, as this is not an AI/ML driven device requiring such clinical validation. Laboratory (bench) testing of the device itself would likely involve a small number of units (e.g., 3-10).
• Data Provenance: Not applicable in the context of patient data. The provenance for the device's technical specifications would be from internal engineering and manufacturing. This is a physical medical device, not a software device processing patient data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a negative pressure wound therapy system, not an imaging analysis or diagnostic AI/ML device requiring expert interpretation for ground truth establishment.

4. Adjudication Method

Not applicable. There is no expert review or adjudication process outlined for this type of device submission. Performance is based on engineering specifications and bench testing.

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

Not applicable. This is not an AI/ML diagnostic or assistive device that would participate in an MRMC study to compare human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. Ground truth for an AI/ML context doesn't apply here. The "truth" for this device lies in its adherence to engineering specifications, safety standards, and functional performance metrics (like creating negative pressure). Bench testing and electrical safety compliance form the basis of "truth."

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model is involved.

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Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

XLR8 White Foam Dressing is appropriate for use on the following wounds:

• Pressure ulcers
• Diabetic/Neuropathic Ulcers
• Venous insufficiency Ulcers
• Traumatic wounds
• Post-operative and dehisced surgical wounds
• Skin flap and grafts

The Genadyne XLR8 White Foam Dressing Kit is a Rx only device.

The Genadyne XLR8 White Foam Kit consists of a XLR8 Port, XLR8 Transparent Film and a XLR8 White Foam. Each component are packaged, sealed and sterilized individually and then bagged.

The provided text describes a 510(k) premarket notification for a medical device and includes summaries of non-clinical tests. However, it does not contain the kind of detailed information typically found in a study proving a device meets specific clinical acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and biocompatibility/bench testing. It does not describe a study involving human patients or AI algorithms in the ways requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

Acceptance Criteria and Study Details

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

   The document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes (e.g., wound healing rates, infection reduction) against specific numerical targets. The "Acceptance Criteria" mentioned for non-clinical tests are qualitative (e.g., "not considered to have a cytotoxic effect," "meets the requirements of the ISO 10993-10 guidelines," "performs up to the acceptability criteria").

   Acceptance Criterion (Non-Clinical)	Reported Device Performance (Non-Clinical)
   ISO 10993-5 Cytotoxicity Test	"not considered to have a cytotoxic effect."
   ISO 10993-10 Kligman Maximization	"Grade 1 reaction" and "classified as having weak allergenic potential." "Grade 1 sensitization rate is not considered significant and the test article meets the requirements of the ISO 10993-10 guidelines."
   ISO 10993-10 Intracutaneous	"test article sites did not show a significantly greater biological reaction than the sites injected with the control article." "the test article meets the requirements of the ISO 10993-10 guidelines."
   Bench Tests for Performance	"dressing kit components are all compatible and performs up to the acceptability criteria." (Specific numerical criteria not provided)
   Stability Test	"Devices has passed and met all expectations of the stability tests in terms of bioburden, packaging, seal integrity and performance." (Specific numerical criteria/results for "expectations" not provided)

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

   • Test Set Sample Size: Not applicable. The tests described are non-clinical (biocompatibility and bench tests), not a clinical 'test set' in the context of AI or diagnostic performance studies. The specific number of test items (e.g., foam samples) used for each non-clinical test is not provided.
   • Data Provenance: Not applicable for clinical data. For the non-clinical tests, the provenance is a laboratory setting. No country of origin for clinical data is relevant here.
   • Retrospective or Prospective: Not applicable as no clinical study is described.

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. No clinical test set or ground truth established by experts is described. The non-clinical tests are evaluated against established laboratory protocols and standards (e.g., ISO 10993 guidelines).

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

   Not applicable. No test set requiring expert adjudication is 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

   No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This document pertains to a wound dressing kit, not an AI-powered diagnostic or assistive tool.

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

   Not applicable. The device is a physical wound dressing kit, not an algorithm, so a standalone algorithm performance study is irrelevant.

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

   Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" or reference for passing is established by adherence to recognized international standards (e.g., ISO 10993) and pre-defined acceptance criteria within those standards.

8. The sample size for the training set

   Not applicable. There is no AI model or algorithm described that would require a training set.

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

   Not applicable. As there is no AI model or training set, this question is not relevant to the provided text.

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The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.

The Melodi Prime breast pump is a battery operated breast pump. It operates with 4 AA size batteries. It comes with a power adapter as it can be used with a power adapter without batteries as well. The power adapter does not charge the batteries.

The Melodi Prime breast pump is designed to be a single patient use device. It consists of a LCD display that allows the user to see the current settings of the device. It is an easy to use device, consist of 5 buttons (On/Off, + , - , Phase 1/ Phase 2, & Single/ Double Pumping).

The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.

The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Melodi Prime Breast Pump:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabulated format. However, it describes performance characteristics that were tested and deemed acceptable for demonstrating substantial equivalence.

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

• Sample Size for Test Set: Not specified. The document refers to "bench tests" and "back flow tests" but does not detail the number of units or test repetitions.
• Data Provenance: Not explicitly stated, but the context indicates these were conducted internally by the manufacturer or a contract lab as part of the 510(k) submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective experimentation.

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

• Number of Experts: Not applicable. The "ground truth" for technical performance criteria (like pressure consistency, back-flow prevention, and durability) is typically established through objective measurements and engineering standards, not expert clinical consensus in this context.
• Qualifications of Experts: Not applicable for the described tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests described are objective bench tests, not subjective evaluations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a breast pump, and its effectiveness is determined by mechanical performance, safety, and functionality, not by interpretation by human readers.

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

• Standalone Study: Yes, in essence, the "Performance Data" section describes standalone testing of the device's mechanical and functional characteristics without human intervention influencing the fundamental performance results. It's not an "algorithm" in the typical software sense, but the device's inherent operation was tested.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance tests was based on objective measurements against engineering specifications and physical principles. For example, pressure levels are measured by sensors, back-flow is visually or mechanically confirmed, and durability is timed.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" of data in the typical sense.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

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