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PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

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 incisions

PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

This document pertains to a 510(k) premarket notification for the PICO Single Use Negative Pressure Wound Therapy System. The submission declares the device substantially equivalent to a previously cleared predicate device (K172521). The changes are specifically for alternative, non-critical components within the printed circuit board assembly due to resourcing issues.

Therefore, the study's purpose is to demonstrate that the new component changes do not adversely affect the device's original performance and that it remains substantially equivalent to the predicate.

Here's an analysis based on the provided text, addressing your questions:

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

Relevant IEC Standards for Compliance:

• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 – C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
• IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
• IEC 60601-1-6 Edition 3.1 2016-10 – Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability
• IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment

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

• Sample Size for Test Set: Not explicitly stated. The document indicates "Testing demonstrated that the alternative, non-critical components perform equivalently..." and "The pumps were able to operate...", implying a sample of devices (pumps) was tested, but the specific number is not provided.
• Data Provenance: The testing was conducted by Smith & Nephew Medical Ltd. No country of origin for specific testing data is mentioned, but the submitter is based in the United Kingdom and the application correspondent in the USA. The study design appears to be internal verification/validation testing.

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 this study is a technical/performance verification for component changes, not a clinical study requiring expert diagnosis or ground truth establishment in a medical context. The "ground truth" here is the established performance specifications of the predicate device and relevant industry standards.

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

• Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving expert review of medical images or outcomes. This study is an engineering verification of component performance against established standards, so an adjudication method in this sense is not applicable. The 'adjudication' would be the comparison of test results against the specified performance ranges and regulatory 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a negative pressure wound therapy system (a medical device, not an AI diagnostic tool), and the study described focuses on technical performance verification of component changes. Therefore, there's no AI component and no measure of human reader improvement.

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

• This question is not applicable. The PICO Single Use Negative Pressure Wound Therapy System is a physical medical device, not an algorithm or AI system. The study focused on the functional performance of the device's electrical components.

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

• The "ground truth" in this context refers to the established performance specifications and regulatory standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, etc.) for negative pressure wound therapy devices, as well as the prior performance of the predicate device. The goal was to prove the new components maintained this established level of performance.

8. The sample size for the training set

• This information is not applicable. This is not an AI/machine learning study that requires a training set. The study involves hardware component testing.

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

• This information is not applicable for the same reason as point 8.

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