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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:

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

The "test set" for this submission is comprised of studies identified through a systematic literature review. This means the data is retrospective, as it relies on previously published research. The provenance of the data is global, as the literature review included studies from various researchers and institutions, not limited to a single country.

• Overall SSI Meta-analysis:

  • Evaluable patients: 2,737 in the PICO Family therapy group, 2,936 in the SOC (control) group.
  • Total studies: 17 (12 RCTs, 5 prospective observational).

• Superficial SSI Meta-analysis:

  • Evaluable patients: 356 in the PICO Family therapy group, 367 in the SOC (control) group.
  • Total studies: 8 (5 RCTs, 3 prospective observational).

• Deep SSI Meta-analysis:

  • Evaluable patients: 1,146 in the PICO Family therapy group, 1,138 in the SOC (control) group.
  • Total studies: 6 (4 RCTs, 2 prospective observational).

• Post-operative Seroma Meta-analysis:

  • Evaluable patients: 608 in the PICO Family therapy group, 618 in the SOC (control) group.
  • Total studies: 10 (7 RCTs, 3 prospective observational).

• Dehiscence Meta-analysis:

  • Evaluable patients: 551 in the PICO Family therapy group, 656 in the SOC (control) group.
  • Total studies: 7 (6 RCTs, 1 prospective observational).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the test set (the outcomes of the studies included in the meta-analysis) was established by the original researchers and clinicians who conducted each individual study. The document states:

• "Two (2) independent reviewers performed the study selection."
• "In case of disagreement a third reviewer made the final decision after reading the full text paper or conference abstract."
• "Data was extracted from included studies by one reviewer using a predefined and standardized data extraction form and checked by a second reviewer for accuracy."

The qualifications of these specific reviewers are not provided in the document. However, the outcomes themselves (SSI, seroma, dehiscence) are medical diagnoses and complications identified by the healthcare professionals directly involved in the patient care and study follow-up within the original research for each of the 25 articles. These would typically be surgeons, nurses, and other medical personnel, under the guidance of the study investigators.

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

For the selection of studies for inclusion in the meta-analysis:

• "Two (2) independent reviewers performed the study selection."
• "If either reviewer deemed an article as potentially relevant, then the article progressed to full text screening."
• "In case of disagreement a third reviewer made the final decision after reading the full text paper or conference abstract."
  This indicates a 2-reviewer initial screening with a third reviewer for adjudication in case of disagreement (2+1 method) for study selection.

For data extraction:

• "Data was extracted from included studies by one reviewer using a predefined and standardized data extraction form and checked by a second reviewer for accuracy."
  This implies a single reviewer for initial extraction with a second reviewer for verification, which is a form of 1+1 review.

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 MRMC comparative effectiveness study was done, nor is this device an AI-powered diagnostic tool. The document describes a medical device (Negative Pressure Wound Therapy System) and its clinical effectiveness compared to standard care through a meta-analysis of existing clinical trials, not an AI system. Therefore, details regarding human reader improvement with/without AI assistance are not applicable.

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

This refers to a medical device, a wound therapy system, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) is not applicable. The device operates independently of human interpretation in its direct therapeutic action (applying negative pressure), but its application and management involve healthcare professionals.

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

The ground truth for the effectiveness claims of the PICO family of devices (reduction in SSI, seroma, and dehiscence) is based on outcomes data from various clinical studies. These outcomes (e.g., incidence of infection, presence of seroma, occurrence of dehiscence) were reported by the original study investigators, presumably determined through clinical assessment, and potentially supported by other diagnostic methods (e.g., microbiology for infection, imaging for seroma, clinical examination for dehiscence), depending on the specific protocols of each individual study included in the meta-analysis. For infection, the CDC guidelines for defining SSI were used, which involve clinical criteria.

8. The sample size for the training set

This document describes a medical device and its clinical effectiveness evaluated through a meta-analysis of clinical studies, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable here.

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

As explained in point 8, the concept of a "training set" is not applicable to this submission.

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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

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes in terms of number of devices or number of tests for each "bench test" conducted. The descriptions refer to "all dressings" or "the PICO 7Y device" without quantifying the number of units tested. This is common for this type of K submission where the focus is on demonstrating that the device can meet the specification, rather than statistical significance derived from large sample sizes.

• Sample Size: Not explicitly stated for specific tests (e.g., "Wound model testing was conducted on the PICO 7Y system..." implies multiple dressings/tests, but exact number unknown).
• Data Provenance: The tests are described as "Non-Clinical Tests (Bench)" indicating laboratory-based testing. A "summative study" for Human Factors was "carried out in the US." The origin of the actual materials used in testing (e.g., simulated wounds) is not detailed. All data appears to be prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this device. As a powered suction pump, the "ground truth" is based on objective physical measurements (e.g., pressure, flow rate, volume) and engineering standards, not on expert interpretation of medical images or clinical outcomes that require human consensus. No experts were used to establish ground truth in the typical sense for an AI/software device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used in studies involving human interpretation (e.g., radiology reads) where there might be inter-reader variability. For objective bench tests of a physical device, results are based on defined measurement protocols and pass/fail criteria, not on human judgment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of AI/software assistance on human performance (e.g., how AI improves a radiologist's ability to detect disease). This device is a physical therapy system, not a diagnostic or AI-assisted interpretation tool. Therefore, no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device. There is no "algorithm only" component in the sense of a diagnostic or interpretive AI. Its performance is measured directly through its mechanical and functional operation.

7. Type of Ground Truth Used

The ground truth for the performance of the PICO 7Y system was based on:

• Engineering Specifications and Benchmarking: Pre-defined ranges for pressure (e.g., -60 to -100 mmHg), flow rates (e.g., 0.6 g/cm²/24 hours), and time intervals (e.g., <100 seconds to reach target pressure, 24-hour indicator activation).
• Simulated Clinical Scenarios: Use of simulated wounds (25% of dressing absorbent pad area) and simulated fluid volumes (50ml, 600ml) to mimic real-world conditions in a controlled laboratory environment.
• Industry Standards: Compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601 series).

This is analogous to "bench testing" against defined performance parameters and safety standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in the context of device development described here.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as point 8.

Ask a specific question about this device

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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