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

When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7 Single Use Negative Pressure Wound Therapy System 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. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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

When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7Y Single Use Negative Pressure Wound Therapy System 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. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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

When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

• Superficial incisional surgical site infections for high risk patients in Class I wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 14 Single Use Negative Pressure Wound Therapy System 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. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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

When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
• Post-operative seroma
• Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:

• PICO Pump
• Dressing (s)
• Fixation strips
• Batteries
• Connection tubing
• Instructions for Use

The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.

The PICO family of devices (PICO, PICO 7, PICO 7Y, and PICO 14) are Negative Pressure Wound Therapy Systems intended for use in wound treatment.

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

The provided document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it demonstrates the device's effectiveness through a systematic literature review and meta-analyses, aiming to show a "statistically significant reduction" in the incidence of certain wound complications compared to standard care. The reported device performance is presented as Odds Ratios (OR) with 95% Confidence Intervals (CI). A favorable effect is suggested by an OR less than 1.

Here's a summary of the meta-analysis results as reported:

| Outcome | Device Performance (Odds Ratio [95% CI]) | Interpretation (Favorable Effect if OR

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PICO 7Y 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 Systems are suitable for use both in a hospital and homecare setting.

PICO 7Y Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a Yshaped tube known as the "Y-Connector" to two super-absorbent, gentle adhesive dressings. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressings and fixation strips are supplied sterile and for single use. PICO 7Y was designed to deliver negative pressure wound therapy to low and moderate exudate levels of acute and chronic wound types. PICO 7Y Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

The provided text describes the PICO 7Y Single Use Negative Pressure Wound Therapy System, focusing on performance testing and regulatory clearance. It is important to note that this device is a physical medical device (a powered suction pump) and not an AI device or software. Therefore, the typical acceptance criteria and study designs associated with AI/software devices (e.g., MRMC studies, expert consensus on image interpretation, training/test set ground truth establishment for algorithms) are not applicable here.

However, I can extract the acceptance criteria and study details relevant to this physical medical device based on the information provided in the K182323 submission.

Acceptance Criteria and Device Performance for PICO 7Y Single Use Negative Pressure Wound Therapy System

Given that this is a physical medical device (a Negative Pressure Wound Therapy system) and not an AI or software product, the acceptance criteria and study focus on mechanical and performance-based metrics, rather than diagnostic accuracy or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

Here's an analysis of the provided text regarding the PICO Single Use Negative Pressure Wound Therapy System, focusing on acceptance criteria and supporting studies.

Based on the provided K172519 FDA 510(k) summary, the device PICO Single Use Negative Pressure Wound Therapy System is stated to be substantially equivalent to a previously cleared predicate device (K163387). The core of this submission is not about proving new clinical effectiveness or performance claims for a novel device, but demonstrating continued compliance with updated safety and performance standards for an existing design.

Therefore, many of the requested points related to clinical studies (sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this specific submission. The submission focuses on engineering and regulatory compliance testing, rather than clinical performance evaluation.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

Explanation: The "acceptance criteria" in this context are the updated versions of international safety and performance standards for medical electrical equipment. The "reported device performance" is the assertion by the manufacturer, accepted by the FDA for substantial equivalence, that the device meets these updated standards. No specific numerical performance metrics (e.g., suction pressure, battery life, etc.) are explicitly detailed as "acceptance criteria" distinct from the standards themselves in this document, as the core device design is unchanged from the predicate.

Regarding Clinical Performance Studies:

The document states, "The subject device and the predicate device are the same. The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601." This means the submission does not include new clinical performance studies to establish efficacy or clinical acceptance criteria beyond what was demonstrated for the predicate device. The focus is on updated safety and usability standards. Therefore, the following points are largely not applicable (N/A) in the context of this specific 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. This submission focuses on engineering and regulatory compliance testing rather than clinical performance testing with human subjects. The device itself was retested against updated standards, not a clinical "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. No clinical "ground truth" was established as part of this submission, as it's not a clinical performance study. The "ground truth" here is the adherence to technical standards, validated by testing laboratories.

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

• N/A. No clinical "test set" requiring adjudication methods was used.

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

• N/A. This is not an AI-enabled device and no MRMC studies were conducted.

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

• N/A. This device does not involve an algorithm or AI that would require standalone performance evaluation in that sense.

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

• N/A (for clinical ground truth). The "ground truth" for this submission refers to the specifications and requirements defined by the international medical device standards (e.g., IEC60601 series). Testing houses (CSA Group and Intertek Testing Service NA, Inc) performed evaluations to confirm the device met these technical requirements.

8. The sample size for the training set

• N/A. No training set was used as this is not an AI/ML device or a clinical study requiring data training.

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

• N/A. No training set and thus no ground truth for a training set was established for this submission.

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