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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.

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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.

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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.

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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.

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