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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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The Cork Medical Products Nisus Negative Pressure Wound Therapy 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.

Cork Medical Products has developed a negative pressure wound therapy system. The Cork Medical Products Nisus Negative Pressure Wound Therapy 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 components included within the Cork NPWT System are:

• Nisus Negative Pressure Wound Therapy Pump
• Nisus NPWT Canister 250-mL
• Nisus Pump Battery Charger
• Cork Medical Products NPWT Wound Dressing Kit – Medium
• Cork Medical Products NPWT Wound Dressing Kit - Large

This document is a 510(k) premarket notification for the "Cork Medical Products Nisus Negative Pressure Wound Therapy System." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each performance test in a tabular format with corresponding reported performance metrics for the Cork Medical Products Nisus NPWT System. Instead, it states that "All biocompatibility test results were negative and passed the pre-defined test acceptance criteria," and that nonclinical tests were conducted "to ensure the Cork Medical Products Nisus Negative Pressure Wound Therapy System is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing." This implies the acceptance criteria for the nonclinical tests were equivalence to the predicate device's performance characteristics.

The comparison table on pages 5 and 6 provides a direct comparison of technical data between the new device and the predicate device. This essentially serves as the 'performance' of both devices that the FDA used to determine substantial equivalence.

Here's a summarized table based on the provided "Predicate Product Comparison Table" and "Nonclinical Tests" section, inferring acceptance criteria as being substantially equivalent to the predicate:

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

• Sample size for nonclinical tests: Not explicitly stated for each test beyond "head to head performance testing," "Canister Real-Time Aging," and "Wound Dressing Kit Aging." For the biocompatibility tests, the sample size refers to the "wound foam and wound drape components" and "individual components included in the Cork Medical Products Wound Dressing Kit." Specific numbers are not provided.
• Data provenance: The tests were conducted internally by Cork Medical Products ("Cork Medical conducted head to head performance testing") and a Biocompatibility Risk Assessment was completed by "Nelson Laboratories." The data origin is thus from Cork Medical's testing and a third-party lab. No information about country of origin of the data or whether it was retrospective or prospective is mentioned, which is typical for premarket notifications focus on non-clinical engineering and bench testing.

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

Not applicable. This device is a negative pressure wound therapy system, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (pressure, flow, alarm functionality) and standardized biocompatibility testing.

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for establishing ground truth, as it's a mechanical/electrical device.

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

Not applicable. This device is not an AI-assisted diagnostic or imaging tool.

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

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

7. The type of ground truth used

• Nonclinical Performance Tests: The "ground truth" for the nonclinical performance tests (e.g., pressure, alarms) was established through engineering and bench testing protocols using "simulated wound exudate" and a "wound test bed fixture." The implicit ground truth standard for these tests was the demonstrated performance of the legally marketed predicate device.
• Biocompatibility Tests: The ground truth was based on international standards, specifically ISO 10993 testing standards, with predefined acceptance criteria for cytotoxicity, intracutaneous reactivity, and sensitization.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have "training sets" in that context. Its performance is based on engineering design and testing, not learned data.

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

Not applicable (as above).

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