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.

Device Description

Not Found

AI/ML Overview

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.

Summary

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April 20, 2018

Smith & Nephew Medical Limited % Kulsum Master Director Regulatory Affairs, US Region Smith & Nephew Austin, Texas 78735

Re: K180618

Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 6, 2018 Received: March 9, 2018

Dear Kulsum Master:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may: therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180618 Device Name

PICO Singe Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

-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.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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