(137 days)
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 suction device consisting of an electric motor driven, twin-diaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.
The provided document, a 510(k) Summary for the PICO Single Use Negative Pressure Wound Therapy System, describes non-clinical (bench) tests to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing an AI device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, expert ground truth, and comparative effectiveness studies is not present in this document.
However, based on the provided text, the following can be extracted regarding the device performance against certain test requirements:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Requirement) | Reported Device Performance |
|---|---|
| Manage fluid at flow rate modeling moderately exuding wound (1.1 g/cm²/24 hours) | All dressings managed fluid at this flow rate. |
| Maintain negative pressure within -60 mmHg to -100 mmHg for ≥95% of test time at simulated wound base | Dressings maintained pressure within range for ≥95% of test time. |
| Manage fluid at flow rate modeling low exuding wound (0.6 g/cm²/24 hours) | All dressings managed fluid at this flow rate. |
| Maintain negative pressure within -60 mmHg to -100 mmHg for ≥95% of test time at simulated wound base | Dressings maintained pressure within range for ≥95% of test time. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions testing "PICO kits 10x20cm, 25x25cm, small multisite 15x20cm, large multisite 20x25cm dressings" for different flow rates and orientations. It also specifically states "PICO kits 25x25cm dressings" were tested for vertical orientation. The exact number of individual dressings or tests within each category is not specified beyond listing the types/sizes.
- Data Provenance: The tests are explicitly described as "Non-Clinical Tests (Bench)". Therefore, the data originates from laboratory bench testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a bench test, not a study requiring expert ground truth for clinical cases. The "ground truth" here is the physical measurement of fluid management and negative pressure maintenance capabilities of the device in a controlled environment.
4. Adjudication method for the test set:
- Not applicable. This was a bench test, not a study requiring expert adjudication of clinical cases. The results are from direct physical measurements.
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. This document describes a medical device (Negative Pressure Wound Therapy System), not an AI diagnostic/treatment support system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. As mentioned above, this is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used:
- The "ground truth" in these bench tests was established through direct physical measurements against predefined performance specifications for fluid management and negative pressure maintenance in a simulated wound model. This is analogous to a physical performance standard or engineering specification.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth for it.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.