Search Results

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. Each NPseal dressing is intended to be used up to 7 days. The total therapy time across multiple NPseal dressing changes is up to 14 days. NPseal therapy must be discontinued after 14 days. NPSeal dressing wear time may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for dressing change.

• The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
• The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
• The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
• The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm.
• The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.

The provided 510(k) clearance letter and summary describe a modification to an existing medical device, the NPseal. The core of this submission is to extend the allowed "Total Therapy Time" from 7 days to 14 days, while the "Single Dressing Wear Time" remains 7 days.

Crucially, the document states that no functional, performance, or clinical testing was conducted for this specific submission (K251156) to support the extended therapy time. Instead, it relies on the safety and effectiveness established for the predicate device (K250708) and asserts that the labeling update itself does not raise new safety or effectiveness concerns.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available within this document for the K251156 submission. The document explicitly states: "No functional or performance testing was completed based on the change" and "No clinical testing was applicable to this submission."

However, we can infer some information based on the nature of a 510(k) submission for a device like this and the reliance on a predicate. The original clearance (K250708) for the predicate device would have involved such testing.

Based on the provided text, here's what can be extracted and what cannot:

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

Not Applicable (N/A) for this specific K251156 submission.
The document explicitly states: "No functional or performance testing was completed based on the change." The acceptance criteria and performance data would have been part of the predicate device's (K250708) submission. Since no new testing was performed for K251156, no new performance data or specific acceptance criteria for the change are reported.

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

N/A for this specific K251156 submission.
No new test set was used, as no new functional, performance, or clinical testing was conducted. The reliance is on prior V&V data from the predicate device.

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 for this specific K251156 submission.
No new test set was evaluated with expert ground truth, as no new studies were conducted.

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

N/A for this specific K251156 submission.
No new test set was adjudicated.

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 device (Negative Pressure Wound Therapy Non-Powered Suction Apparatus) is not an AI/imaging device that would typically involve human readers or MRMC studies.

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

N/A. This device does not incorporate an algorithm in the typical sense (e.g., for automated diagnosis or image analysis). It is a mechanical device.

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

N/A for this specific K251156 submission.
No new ground truth was established for the purpose of this submission, as no new studies were conducted. For the predicate device, ground truth for performance would likely have been established through physical and mechanical testing (e.g., pressure measurements, exudate absorption capacity, material biocompatibility) rather than clinical "ground truth" as seen in diagnostic device studies.

8. The sample size for the training set

N/A. This device does not involve machine learning or a "training set."

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

N/A. This device does not involve machine learning or a "training set."

Summary of Device and Rationale for Clearance without New Testing:

The K251156 submission is a Special 510(k) based on the "The Special 510(k) Program" guidance. This program is for modifications to a manufacturer's own legally marketed device where the change does not pose new questions of safety or effectiveness.

• Device Name: NPseal
• Device Type: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy (NPWT)
• Modification: Extension of the "Total Therapy Time" from 7 days to 14 days. Crucially, the "Single Dressing Wear Time" remains 7 days. This implies that therapy over 14 days would involve at least one dressing change.
• Rationale for No New Testing: The FDA's clearance suggests that changing the total therapy duration from 7 to 14 days, while keeping the single dressing wear time at 7 days, was considered a minor labeling change that does not introduce new risks or alter the fundamental performance of the device that was already proven safe and effective for up to 7 days, presumably including multiple dressing changes within that 7-day period. The assumption is that if a patient can safely use the device for two 7-day periods (with a dressing change) in sequence, then extending the total therapy time to 14 days doesn't inherently change the device's mechanism of action or safety profile. The previous verification and validation data from the predicate (K250708) were deemed sufficient to support this extended timeframe.

Ask a specific question about this device

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range.

The NPseal is intended for 7 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change.

• The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
• The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
• The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
• The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm.
• The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.

The provided text is a 510(k) clearance letter for a medical device called NPseal. It is crucial to understand that this document describes a Special 510(k) submission, which is used for minor changes to an already cleared device. In this case, the changes were:

• Adding an MR safety statement to labeling.
• Minor labeling updates regarding wear time and latex content.
• Adding an alternate source for a material (hydrophilic polyurethane foam).

The core of a Special 510(k) is to demonstrate that the minor modifications do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the cleared predicate device. This is different from a de novo submission or a traditional 510(k) for a novel device or significant change, which would typically involve more extensive clinical performance studies.

Therefore, the "studies" mentioned in this document are primarily non-clinical performance testing to ensure the alternative material performs equivalently, and no clinical trials or human-in-the-loop studies (like MRMC studies) were conducted or needed for this specific Special 510(k) submission. The FDA's acceptance is based on the equivalency demonstrated through bench testing and material assessments, not on clinical performance criteria like diagnostic accuracy.

Analysis of the Provided Information against the Request:

Based on the nature of a Special 510(k) for these specific changes, many of the requested elements (especially those related to clinical performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this document. The "device performance" here refers to physical and material performance, not diagnostic accuracy or human-in-the-loop clinical benefit.

Here's an attempt to answer your questions based only on the provided text, highlighting what is applicable and what isn't:

Acceptance Criteria and Device Performance for NPseal (K250708)

The acceptance criteria for this Special 510(k) submission primarily revolved around demonstrating that the modifications (specifically, the alternative foam source) maintained the same performance and safety profile as the predicate device (K241522). This is centered on non-clinical performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of number of units or patients for performance testing. As this is a Special 510(k) focused on material equivalency, "test sets" would refer to units used in bench testing.
• Data Provenance: Not specified. Performance and shelf-life testing would typically be conducted in a laboratory setting, likely at the manufacturer's or a contract lab's facility. It's non-clinical data, not patient data. This was not a clinical study.

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

• Not Applicable. No ground truth in the sense of clinical diagnoses or expert consensus was established for a "test set" from patient data, as this was not a clinical study assessing diagnostic performance or clinical outcomes. The "ground truth" here is the technical specification of the predicate device, against which the modified device's bench test results were compared.

4. Adjudication Method for the Test Set

• Not Applicable. There was no expert adjudication process as this was non-clinical performance testing, not a clinical study requiring human interpretation of medical images or data.

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

• No. An MRMC study was not done. This type of study is relevant for AI/imaging devices to show how AI assists human readers. The NPseal is a physical wound therapy device, and this particular submission involved material and labeling changes, not development or modification of an AI component or a diagnostic aid.

• Effect Size: Not applicable, as no MRMC study was performed.

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

• Not Applicable. The NPseal is a physical medical device, not a diagnostic algorithm. Therefore, "standalone performance" of an algorithm is not relevant. The closest analogous concept would be the device's physical performance (e.g., maintaining negative pressure), which was assessed via bench testing to be equivalent.

7. The Type of Ground Truth Used

• Technical Specifications / Predicate Device Performance Data: The "ground truth" for affirming substantial equivalence in this context was the established, documented performance specifications and safety profile of the legally marketed predicate NPseal device (K241522). The new material and changes had to meet or exceed these existing, validated specifications through non-clinical testing.

8. The Sample Size for the Training Set

• Not Applicable. There was no "training set" in the context of machine learning or AI, as this submission did not involve an AI/algorithm.

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

• Not Applicable. (See #8)

In summary, this document highlights a Special 510(k) for minor changes to an already cleared physical medical device. The "study" proving acceptance was primarily non-clinical bench testing to demonstrate that the revised device, particularly with an alternate material source, met the same performance specifications as its predicate. Clinical trials, human reader studies, or AI algorithm training/testing were not part of this specific submission.

Ask a specific question about this device

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 7 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm. The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.

The provided text is a U.S. FDA 510(k) summary for the NPseal device. It states that the device is a Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy. The document describes modifications to an already cleared device, specifically the introduction of longer versions (NPseal 20 and NPseal 25).

Crucially, the document does not describe the specific acceptance criteria or a study that proves the device meets those acceptance criteria in the context of typical AI/ML medical device performance studies (e.g., sensitivity, specificity, AUC). This is because the device, Guard Medical's NPseal, is a negative pressure wound therapy device, not an AI/ML diagnostic or prognostic device. The 510(k) submission is for a physical medical device with design modifications (longer versions), not a software or AI algorithm.

Therefore, many of the requested information points (like AI performance metrics, sample size for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable to this type of device and submission.

However, I can extract information related to the performance testing that was conducted for this device modification, which served as the "proof" that the modified device is substantially equivalent to its predicate.

Here's the reinterpretation of your request based on the provided document:

Device: Guard Medical NPseal (Negate Pressure Wound Therapy Device)

Nature of the Submission: Special 510(k) for device modification – introducing longer versions (NPseal 20 and NPseal 25) of an already cleared negative pressure wound therapy (NPWT) device.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

Since this is a physical medical device and not an AI/ML product, the "acceptance criteria" and "performance" relate to its physical and functional characteristics remaining equivalent or safe despite the size change.

The document refers to "Verification and validation data" supporting substantial equivalence. Based on the "Summary of Functional and Performance Testing," the acceptance criteria would be that the modified devices maintain the crucial functionalities of the predicate device.

Table of Performance Testing and Implied Acceptance Criteria:

Study that Proves the Device Meets the Acceptance Criteria:

The studies conducted were benchtop performance and functional tests, not clinical trials in the sense of large patient cohorts, as this was a Special 510(k) for a modification (size increase).

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated as a numerical sample size of "patients" or "images" as it's a physical device. For benchtop testing, typically multiple units of the device would be tested to ensure consistency and reliability. The document states testing was performed "exclusively on the NPseal 25 as it represents the most challenging device size," implying tests were sufficient to address the change.
• Data Provenance: Not applicable in terms of country of origin for clinical data or retrospective/prospective collection, as no clinical testing was performed for this submission (as stated in Section 9: "No clinical testing was applicable to this submission."). The data originates from internal engineering and quality validation testing by Guard Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This information is relevant for AI/ML diagnostic devices where human experts establish ground truth for image or data interpretation. For a physical device like NPseal, "ground truth" is typically defined by engineering specifications, material properties, and established medical standards for wound care devices, validated through physical and functional testing.

4. Adjudication Method for Test Set:

• Not applicable. No human interpretation or adjudication of test results in the context of diagnostic agreement was required here. Performance was assessed against engineering specifications and functional requirements.

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

• No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. It is not relevant to a negative pressure wound therapy device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The NPseal is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device modification was based on engineering specifications, functional requirements, and performance data from the predicate device. The aim was to demonstrate that the increased sizes (NPseal 20 and NPseal 25) perform equivalently to the predicate devices (NPseal 5, 10, and 15) in terms of established parameters like negative pressure maintenance, exudate handling, and material integrity.

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device. The "training" in a broad sense would be the cumulative design and manufacturing experience for the predicate device.

9. How Ground Truth for Training Set was Established:

• Not applicable. See point 8.

In summary: The provided document is a 510(k) notice for a physical medical device modification, not an AI/ML software device. Therefore, the detailed questions pertaining to AI/ML study methodologies (e.g., AI performance metrics, expert labeling, MRMC studies) are not relevant to this specific FDA submission. The "proof" of meeting acceptance criteria for this device involved benchtop functional and performance testing to demonstrate substantial equivalence to an already cleared predicate device, despite the change in size.

Ask a specific question about this device

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 7 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal Small is intended to remove small amounts of exudate from surgically closed incisions up to 5 cm × 0.5 cm. The NPseal Medium is intended to remove small amounts of exudate from surgically closed incisions up to 10 cm x 0.5 cm. The NPseal Large is intended to remove small amounts of exudate from surgically closed incisions up to 15 cm x 0.5 cm.

The provided text is a 510(k) summary for a medical device called NPseal. This document does not contain information about acceptance criteria for device performance in the context of diagnostic or prognostic accuracy, nor does it describe a study that uses a test set, expert ground truth, or addresses human reader performance with or without AI.

The document describes a submission for a modification to an existing device (NPseal K212971) to allow for 7 days of wear time instead of 6, and some manufacturing-related design changes. The document explicitly states: "No clinical testing was applicable to this submission."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating device performance against acceptance criteria for a diagnostic/prognostic device.

The study described in this document is a non-clinical bench testing and verification/validation study to support the modified device's safety and effectiveness compared to its predicate.

Here's what information can be extracted or inferred from the provided text, related to the nature of this submission:

• Type of Study: Bench testing, verification, and validation of physical device modifications and extended wear time.
• Purpose of Study: To demonstrate substantial equivalence of the modified NPseal to the predicate device, particularly regarding the extended wear time and manufacturing changes.
• Tests Performed (Functional and Performance Testing):
  • Pressure and Exudate Handling Over Time
  • Benchtop Usability Testing
  • Pull Testing
  • Shipping Validation
• Ground Truth: For the "Pressure and Exudate Handling Over Time" test, the "ground truth" would be defined by pre-determined engineering specifications for negative pressure range (-75 to -125 mmHg nominal range) and exudate handling capabilities, both over the extended 7-day period. For "Pull Testing," it would be mechanical strength requirements. For "Usability" and "Shipping," it would be performance against established protocols and acceptance limits for functionality and integrity after use/transport.
• No Clinical Testing: The document explicitly states, "No clinical testing was applicable to this submission." This means there's no clinical trial data to evaluate device performance in patients, nor any data related to diagnostic accuracy, sensitivity, specificity, or human reader performance.
• Sample Size: The document does not specify sample sizes for the bench tests.
• Experts: Not applicable in the context of diagnostic/prognostic device evaluation. Engineering and quality control personnel would have designed, executed, and reviewed these bench tests.

In summary, the provided FDA 510(k) document is for a non-diagnostic device modification and does not contain the type of study data (clinical, AI performance, expert review, etc.) that your request targets.

Ask a specific question about this device

The NPseal is indicated for patients who would management via application of a negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Neqative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range.

The NPseal is intended for 6 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days.

The NPseal Small is intended for surgically closed incisions up to 5cm x 0.5 cm

The NPseal Medium is intended for surgically closed incisions up to 10 cm x 0.5 cm.

The NPseal Large is intended for surgically closed incisions up to 15 cm x 0.5 cm.

The provided text is a 510(k) Summary for the NPseal device, specifically for the Medium and Large versions. It outlines the device description, indications for use, comparison to a predicate device, and functional/performance testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes (e.g., number of devices/units) for each of the performance tests. It mentions that testing was performed "exclusively on the NPseal Large as it represents the worst-case device size," indicating that the tests were conducted using physical samples of the NPseal Large.

• Sample Size: Not explicitly stated for each test (e.g., how many NPseal Large devices were tested for pressure, usability, or packaging).
• Data Provenance: The studies described appear to be prospective benchtop and in-house laboratory testing conducted by Guard Medical (or their designated testing facilities) as part of their design control and 510(k) submission process. There is no indication of external or retrospective data from patients. The country of origin of this testing data is not specified, but the applicant and consultant are based in the USA.

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

There is no mention of experts being used to establish ground truth for the test set. The tests described (Pressure and Exudate Handling, Benchtop Usability, Packaging Validation) are objective functional and performance tests with predefined acceptance criteria that do not typically require expert consensus for ground truth establishment. For usability, a group of users might be involved, but they would be testers, not "experts" establishing ground truth in the sense of a diagnostic interpretation.

4. Adjudication Method for the Test Set

Since the described studies are objective functional and performance tests (e.g., measuring pressure, observing exudate absorption, confirming sterilization seal integrity), an "adjudication method" as typically understood in studies involving subjective interpretations (like medical imaging) is not applicable and therefore not mentioned. The results are based on direct measurements and observations against pre-defined engineering and performance specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was applicable to this submission." The submission focuses on demonstrating substantial equivalence through bench testing, comparing the larger NPseal sizes to the already cleared smaller NPseal predicate.

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

This question is not applicable to this device. The NPseal is a physical medical device (a non-powered negative pressure wound therapy device), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant. The focus is on the device's mechanical and material performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims are based on pre-defined engineering specifications, regulatory standards (e.g., ISO 10993-1), and the performance characteristics of the predicate device.

• For pressure maintenance, the ground truth is the specified pressure range (-75 to -125 mmHg).
• For exudate handling, the ground truth includes criteria like "capable of absorbing simulated exudate" and "less than 50% foam pad coverage."
• For usability, the ground truth is the successful completion of specific tasks (pump actuation, removal from packaging, application, generation of negative pressure).
• For packaging, the ground truth is maintaining seal integrity.
• For biocompatibility, the ground truth is compliance with ISO 10993-1.

These are objective, measurable standards rather than subjective expert consensus, pathology, or outcomes data typically used for diagnostic or treatment effectiveness claims.

8. The Sample Size for the Training Set

This question is not applicable. The NPseal is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The design and development process for a physical device involves engineering principles, material science, and iterative testing, not data-driven training of a model.

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

This question is not applicable for the same reason as point 8. There is no training set for a physical device.

Ask a specific question about this device

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 6 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing result in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.

This document describes a Special 510(k) submission for the NPseal device, focusing on a labeling modification to extend the wear time from 3 days to 6 days. Due to this being a Special 510(k) and the nature of the device (non-powered suction apparatus for negative pressure wound therapy), the study performed is primarily performance and functional testing rather than a complex clinical or AI-based study.

Here's the breakdown of the acceptance criteria and the study, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes (e.g., number of devices or test units) used for the pressure and exudate handling over time, or for the shelf-life testing. These would typically be determined based on statistical justification for engineering bench testing, but are not disclosed in this summary.

The data provenance is from bench testing (laboratory-based performance and functional testing). The country of origin for the data is implicitly the United States, given Guard Medical Inc.'s location in Miami, FL, and the FDA submission. The testing would be considered prospective in the sense that it was conducted specifically to support this 510(k) submission for the modified device.

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

This type of submission (Special 510(k) for a non-AI/imaging device with a labeling change based on performance testing) does not involve medical experts establishing ground truth in the way an AI diagnostic tool would. The "ground truth" here is based on engineering specifications, validated test methods, and performance against established benchmarks (i.e., the predicate device's performance over its shorter wear time). The experts involved would be engineers, materials scientists, and quality/regulatory personnel who designed and executed the tests and interpreted the results against defined acceptance criteria. Their qualifications would be in their respective technical fields.

4. Adjudication Method for the Test Set

No adjudication method as typically understood in human-reader studies (e.g., 2+1, 3+1 consensus) was performed. The data generated is from objective, quantitative bench testing, assessed against predefined engineering specifications and performance targets from the predicate device.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the performance of human readers with and without AI assistance is compared. The NPseal is a physical medical device, and the changes relate to its wear time and shelf-life, not its diagnostic capability or a human-in-the-loop diagnostic process.

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

No, this question is not applicable. The NPseal is a physical device, not an algorithm. Its "standalone" performance refers to its ability to maintain negative pressure and manage exudate, which was evaluated through the "Pressure and Exudate Handling Over Time" and "Shelf-Life Testing" mentioned.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Specifications and Performance Benchmarks: The device must maintain specific negative pressure ranges and manage exudate effectively over the specified wear time.
• Predicate Device Performance: The modified device's performance must be substantially equivalent to, or better than, the predicate device's performance regarding safety and effectiveness, even with the extended wear time.
• International Standards: Compliance with standards like ISO 10993-1 for biocompatibility is also a form of established "ground truth" for material safety.

It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.

8. The Sample Size for the Training Set

This question is not applicable. The NPseal is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable as there is no training set for this device.

Ask a specific question about this device

The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHq to -125 mmHq nominal range. The NPseal is intended for 3 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing results in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.

(1) A table of acceptance criteria and the reported device performance:

The provided text does not contain explicit acceptance criteria in a table format with corresponding reported device performance, as one might find in a detailed study report. Instead, it lists the types of performance data submitted for FDA's substantial equivalence determination.

Summary of Performance Data Submitted:

The "Conclusions" section states: "The test data support the safety of the device and the hardware verification and validation demonstrate that the NPseal shall perform as intended in the specified use conditions." This implies that the device met the internal acceptance criteria for each of these tests, although the specific numerical or qualitative targets for these criteria are not detailed in this summary.

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

The provided document is a 510(k) summary for a medical device (NPseal). It summarizes the performance data used to support substantial equivalence. It does not provide details on the sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective for the various tests mentioned (Biocompatibility, Bench, and Human Factors). These details would typically be found in the full study reports, which are not part of this summary document.

(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 provided in the document. The NPseal is a physical device (non-powered suction apparatus for negative pressure wound therapy), not an AI/imaging diagnostic device that would typically rely on expert ground truth for a "test set" in the way an AI algorithm for image analysis does. The studies mentioned (biocompatibility, bench testing, human factors) involve laboratory or user-based assessments, not an expert panel reviewing diagnostic outcomes for ground truth establishment.

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

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving expert interpretation of data (e.g., medical images) where discrepancies need to be resolved to establish ground truth. As the NPseal is a physical medical device for wound therapy and the studies mentioned are largely laboratory or performance-based, such adjudication would not be relevant.

(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 and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. The NPseal is a non-powered suction apparatus for negative pressure wound therapy, not a diagnostic imaging device or an AI assistance tool for human readers.

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

This information is not applicable and therefore not provided. The NPseal is a physical medical device, not a standalone algorithm. The performance data provided relate to the physical and functional aspects of the device, as well as its interaction with users (human factors).

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

The concept of "ground truth" in the context of an AI or diagnostic study does not directly apply to the testing of the NPseal device as described. The testing (biocompatibility, bench testing, human factors) would have established expected performance parameters and safety profiles against predetermined engineering specifications, international standards (e.g., ISO 10993-1), and user requirements. For example:

• Biocompatibility: Ground truth would be the established safety limits and biological responses as defined by ISO standards.
• Bench Testing: Ground truth would be the engineering specifications for pressure, exudate handling, material strength, etc.
• Human Factors Testing: Ground truth would be the user performance against predefined usability objectives and safety critical tasks.

(8) The sample size for the training set:

This information is not applicable and therefore not provided. The NPseal is a physical medical device, not an AI algorithm that requires a training set. The various tests performed (biocompatibility, bench, human factors) are part of the verification and validation process for a hardware device, not model training.

(9) How the ground truth for the training set was established:

This information is not applicable and therefore not provided, as there is no "training set" for this physical medical device.

Ask a specific question about this device

SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.

SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:

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

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description.

SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately.

SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use.

SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.

The provided text describes a 510(k) premarket notification for a medical device (Anscare SIMO Negative Pressure Wound Therapy (NPWT) System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. It does not present a study proving the device meets acceptance criteria in the format of a clinical trial or a machine learning model's performance evaluation against specific metrics.

Therefore, I cannot extract the information required to answer your request in the specified format, as the document details bench testing, biocompatibility, and sterilization, but not a study designed to evaluate performance against the kind of "acceptance criteria" you've outlined (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).

The provided text details the following:

• Device: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
• Intended Use: Promotes wound healing via removal of excess exudate and infectious materials. Suitable for hospital and homecare settings for various wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts, closed surgical incisions).
• Predicate Device: SNaP® Wound Care System (K151710) and Reference Device: PICO Single Use Negative Pressure Wound Therapy System (K151436).
• Testing Performed:
  • Bench Testing: Tubing Tensile Strength Test, Adhesive test, Function Test after Drop Testing, Life Time for 30 Days Test (pump performance over 150 presses), Simulation Test (performance with low/moderate exudate, pressure stability, exudate management, fluid reflux rate), HFE/UE Report (Human Factors and Usability Engineering).
  • Biocompatibility Testing: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Skin irritation, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Pyrogen Test, Subacute/subchronic toxicity, Implantation study, Phthalate leachables study.
  • Sterilization Testing: Verification of Ethylene Oxide (EO) sterilization process and residual testing per ISO standards.

This documentation serves to demonstrate that the device is as safe and effective as a legally marketed predecessor, not to provide statistical performance metrics typically seen in AI/ML device submissions or clinical trials.

Ask a specific question about this device

SNaP System with SNaP Cartridge (60cc):

The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

SNaP System with SNaP Plus Cartridge (150cc):

The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, singleuse, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is based on the concept of forced expansion of volume to produce negative pressure at the wound bed or at the closed incision, utilizing dedicated constantforce springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. It is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician.

This document is a 510(k) premarket notification for a medical device called the "SNaP® Wound Care System." It describes modifications to an already cleared device, not a new device requiring a full efficacy study. As such, the information typically found in a study proving a device meets acceptance criteria, such as detailed clinical study results with specific sample sizes, ground truth establishment, adjudication methods, or multi-reader multi-case studies, is not present here.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical, bench testing. The acceptance criteria are essentially met by showing the modified device performs similarly to the predicate devices and existing specifications, and that the changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The testing was nonclinical (bench testing), not a clinical trial with a "test set" of patients. The sample sizes would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical trial data. This refers to in-house laboratory testing of the device components and system.

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

• Not applicable. This was a nonclinical submission. "Ground truth" in this context would refer to the established performance requirements and specifications for the device, likely determined by engineering and regulatory standards, and internal quality control. No external experts or medical professionals were involved in establishing "ground truth" for nonclinical bench testing results presented here.

4. Adjudication Method for the Test Set

• Not applicable. This was a nonclinical submission. Adjudication methods are typically relevant for clinical studies where expert consensus or review is needed to classify findings.

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

• No. An MRMC study was not done. This is a nonclinical submission for a wound care system, not an imaging device requiring human reader interpretation.

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

• Not applicable. This is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic tool.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: For nonclinical bench testing, the "ground truth" is defined by established engineering design specifications, internationally recognized standards for medical devices (e.g., for materials, sterilization, pressure levels, and biocompatibility), and internal test protocols. The device's performance is compared against these predetermined specifications.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve an AI algorithm that requires a "training set."

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

• Not applicable. As there is no AI algorithm or training set, this question is irrelevant to this submission.

Summary of the Study (Bench Testing):

The "study" described in the 510(k) notification is a series of nonclinical, bench tests designed to demonstrate that minor design changes and additions to the SNaP Wound Care System do not alter its safety or effectiveness compared to its predicate devices. The modifications included a simplified reset feature, minor material/design changes for commercial scale production, and the addition of a Long Dressing Kit and a SNaP Plus Strap.

The testing covered:

• Device design verification at baseline and after 2-year accelerated aging.
• User requirements verification for the SNaP Plus Strap.
• Verification of 7-day use for the SNaP cartridges.
• Sterilization validation for the new dressing kit.
• Biocompatibility testing.
• Packaging and shelf life testing.

No clinical testing was performed. The collective results of these nonclinical tests formed the basis for concluding that the device meets established specifications and is substantially equivalent to the predicate devices, not raising new questions concerning safety or effectiveness. The removal of a contraindication for use on actively infected wounds was supported by comparison to other NPWT products and published clinical evidence (though not clinical evidence specifically generated for this submission).

Ask a specific question about this device

The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, single-use, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is able to generate negative pressure to allow for the removal of wound exudate/fluid from a wound bed or from a closed incision, utilizing dedicated constant-force springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. This 510(k) premarket notification is for design modifications to the 60cc SNaP Cartridge component of the predicate SNaP Wound Care System, in order to introduce a larger capacity 150cc cartridge available with 125mmHg pressure setting.

The provided document is a 510(k) premarket notification for the SNaP® Wound Care System, specifically for a design modification introducing a larger capacity cartridge. This is not typically a document that includes detailed acceptance criteria and a comprehensive study report in the same way a clinical trial or AI device validation would.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K132080). This means the manufacturer is showing that the modified device is as safe and effective as the existing one, not necessarily proving that it meets specific, quantifiable performance criteria against a disease outcome with a new, standalone study.

However, I can extract the relevant information from the document to construct an answer based on its content, acknowledging the limitations of a 510(k) summary.

Acceptance Criteria and Study for SNaP® Wound Care System (K142272)

The SNaP® Wound Care System's acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a predicate device. The primary performance criteria revolve around the device's ability to generate and maintain negative pressure and manage exudate, aligning with its intended use in wound therapy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of cartridges tested for pressure, number of dressing kits for pressure transmission). It generically states "All necessary bench testing was conducted."
• Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer, Spiracur Inc., in support of their 510(k) application. The data provenance is internal to the manufacturer in sunnyvale CA USA, as it is bench testing to demonstrate equivalance. There is no information about global or specific country of origin for the data beyond the manufacturer's location.

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

• This information is not applicable as the studies described are bench tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here is based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

• Not applicable. Bench testing involves objective measurements against predefined engineering specifications, not subjective human assessments requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical medical device (Negative Pressure Wound Therapy system), not an AI algorithm for diagnostic or prognostic purposes. Therefore, the concept of human readers and AI assistance is not relevant to this 510(k) submission.

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

• Not applicable. This document describes a physical medical device, not an AI algorithm. The performance described is the standalone performance of the device itself (its mechanical and material properties).

7. Type of Ground Truth Used

• The ground truth used for the bench testing was based on engineering specifications, regulatory requirements (e.g., biocompatibility standards), and the established performance characteristics of the predicate device. For example, the "ground truth" for negative pressure generation was 125mmHg ± 17.5mmHg.

8. Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning. The design and modification of the device are based on engineering principles and previous product iterations, not data-driven machine learning training.

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

• Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in that context. The design process for this medical device relies on established engineering and manufacturing standards.

Ask a specific question about this device