(42 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.
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Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the PICO Single Use Negative Pressure Wound Therapy System. However, it's important to note that the provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement, not a detailed study report. Therefore, much of the requested information (like specific acceptance criteria values, detailed study design, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document.
The document primarily focuses on establishing substantial equivalence for the device based on its intended use and comparison to legally marketed predicate devices, rather than presenting a detailed performance study with explicit acceptance criteria for an AI/algorithm-based device.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Indications for Use" and device description) | Reported Device Performance (Inferred from FDA Clearance) |
|---|---|
| Primary Function: Promote wound healing via removal of low to moderate levels of exudate and infectious materials. | The device is deemed "substantially equivalent" to legally marketed predicate devices, implying it is expected to perform its primary function effectively. |
| Appropriate Wound Types: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (diabetic or pressure), Flaps and grafts, Closed surgical incisions. | FDA clearance for these stated indications implies the device is considered safe and effective for these wound types, in line with predicate devices. |
| Usability Setting: Suitable for use in both a hospital and homecare setting. | The device is cleared for both hospital and homecare settings, indicating it meets necessary safety and usability requirements for these environments. |
| Negative Pressure Application: Functions as a suction device (negative pressure wound therapy). | This is the core mechanism of action and is accepted as part of its substantial equivalence. |
| Exudate Management: Removal of low to moderate levels of exudate. | The device is cleared with this specific capability for exudate removal. |
| Infectious Material Management: Removal of infectious materials. | The device is cleared with this capability for infectious material removal. |
Missing specific quantifiable acceptance criteria. The document does not specify quantitative metrics like "achieves X% reduction in wound area" or "maintains Y mmHg pressure for Z hours." The "performance" is implicitly accepted through the substantial equivalence determination to predicate devices.
2. Sample size used for the test set and the data provenance
Not present in the document. This 510(k) clearance letter does not describe a clinical study in terms of sample size for a test set or data provenance. It references a "premarket notification" which would have contained this information, but it's not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not present in the document. This information is typically found in study protocols and reports, which are not part of this FDA clearance letter. Since this is not an AI device, the concept of "ground truth" and expert adjudication in the context of an AI algorithm is largely irrelevant here.
4. Adjudication method for the test set
Not applicable/Not present. As this is not an AI/algorithm-based device and no specific "test set" in that context is described, there is no mention of adjudication methods.
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. The PICO system is a physical medical device (a Negative Pressure Wound Therapy System), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used
Not applicable. For a physical wound therapy device, "ground truth" would typically refer to clinical outcomes (wound healing rates, infection reduction, etc.) observed in clinical trials, rather than expert consensus on diagnostic images or pathology. However, the details of such clinical outcomes are not present in this document. The "ground truth" for FDA clearance in this context is essentially the established safety and effectiveness of the predicate device(s) to which this device is deemed substantially equivalent.
8. The sample size for the training set
Not applicable/Not present. As this is not an AI/machine learning device, there is no "training set" in the computational sense. If refers to clinical data for device development, that information is not in this document.
9. How the ground truth for the training set was established
Not applicable/Not present. See point 8.
Summary of what the document does tell us about the "studies" and "acceptance":
- Device Type: PICO Single Use Negative Pressure Wound Therapy System (a physical medical device).
- Regulatory Pathway: 510(k) Premarket Notification.
- Acceptance Basis: Substantial equivalence to legally marketed predicate devices. This means the FDA compared PICO to existing devices with similar indications for use, technological characteristics, and safety/effectiveness profiles.
- "Study" Implied: The 510(k) submission would have included comparisons to predicate devices, potentially including performance data, but these details are not in this letter. The letter itself is the result of the FDA's review of that submission, not the study report itself.
- Key "Acceptance Criteria" (Implicit): The device must be safe and effective for its stated "Indications for Use" (promoting wound healing via removal of low to moderate exudate and infectious materials for specific wound types in hospital and homecare settings) and must not raise new questions of safety or effectiveness compared to predicate devices.
§ 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.