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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.

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.

Not Found

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

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.

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.

This document pertains to a 510(k) premarket notification for the PICO Single Use Negative Pressure Wound Therapy System. The submission declares the device substantially equivalent to a previously cleared predicate device (K172521). The changes are specifically for alternative, non-critical components within the printed circuit board assembly due to resourcing issues.

Therefore, the study's purpose is to demonstrate that the new component changes do not adversely affect the device's original performance and that it remains substantially equivalent to the predicate.

Here's an analysis based on the provided text, addressing your questions:

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

Relevant IEC Standards for Compliance:

• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 – C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
• IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
• IEC 60601-1-6 Edition 3.1 2016-10 – Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability
• IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment

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

• Sample Size for Test Set: Not explicitly stated. The document indicates "Testing demonstrated that the alternative, non-critical components perform equivalently..." and "The pumps were able to operate...", implying a sample of devices (pumps) was tested, but the specific number is not provided.
• Data Provenance: The testing was conducted by Smith & Nephew Medical Ltd. No country of origin for specific testing data is mentioned, but the submitter is based in the United Kingdom and the application correspondent in the USA. The study design appears to be internal verification/validation testing.

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

• This information is not applicable as this study is a technical/performance verification for component changes, not a clinical study requiring expert diagnosis or ground truth establishment in a medical context. The "ground truth" here is the established performance specifications of the predicate device and relevant industry standards.

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

• Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving expert review of medical images or outcomes. This study is an engineering verification of component performance against established standards, so an adjudication method in this sense is not applicable. The 'adjudication' would be the comparison of test results against the specified performance ranges and regulatory standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a negative pressure wound therapy system (a medical device, not an AI diagnostic tool), and the study described focuses on technical performance verification of component changes. Therefore, there's no AI component and no measure of human reader improvement.

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

• This question is not applicable. The PICO Single Use Negative Pressure Wound Therapy System is a physical medical device, not an algorithm or AI system. The study focused on the functional performance of the device's electrical components.

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

• The "ground truth" in this context refers to the established performance specifications and regulatory standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, etc.) for negative pressure wound therapy devices, as well as the prior performance of the predicate device. The goal was to prove the new components maintained this established level of performance.

8. The sample size for the training set

• This information is not applicable. This is not an AI/machine learning study that requires a training set. The study involves hardware component testing.

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

• This information is 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.

This submission K172521 is for a PICO Single Use Negative Pressure Wound Therapy System. The submission states that "The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601." This means that the device itself has not changed, only the testing and certifications for electrical safety and electromagnetic compatibility to updated standards. Therefore, there are no "acceptance criteria" or "reported device performance" in the typical sense of a clinical or analytical study, as the device's functional performance and efficacy are assumed to be the same as the predicate device.

Instead, the "acceptance criteria" for this submission are related to compliance with updated electrical and usability standards, and the "study" proving it meets these is the retesting and certification by a new testing house.

Here's how the provided information relates to your request:

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

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

This information is not applicable as this is not a study involving patient data or a test set in the clinical/performance sense. The "test set" here refers to the device itself being subjected to engineering tests for compliance with electrical and safety standards.

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

This information is not applicable. Ground truth, in the context of clinical or diagnostic studies, is not relevant here. The "ground truth" for compliance with electrical standards is the standard itself, and the experts are the personnel at the testing and certification body (Intertek Testing Service NA, Inc (USA)) who conducted and verified the tests. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance, but specific numbers and detailed qualifications are not provided in this document.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or image interpretation. Here, the "adjudication" is the formal process of testing and certifying by a recognized body (Intertek) against defined standards.

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

This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices. This device is a negative pressure wound therapy system, not an AI diagnostic tool.

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

This information is not applicable. This is not an algorithm-only device.

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

As explained above, "ground truth" in the typical clinical context is not applicable. The "ground truth" for this submission is compliance with the specified electrical safety, EMC, usability, and home healthcare environment standards (AAMI / ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-6, IEC 60601-1-11).

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable as this is not an AI/machine learning device.

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.

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 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

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.

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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 in both 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 document provided is a 510(k) premarket notification clearance letter for the PICO Single Use Negative Pressure Wound Therapy System. It describes the device, its indications for use, and the modifications compared to a predicate device. The document also details the non-clinical (bench) tests performed to demonstrate substantial equivalence for the modified device.

Here's an analysis of the requested information based on the provided text:

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

The document details specific performance as part of the "Non-Clinical Tests (Bench)". Since these are bench tests and not clinical studies comparing performance against specific acceptance criteria for a new clinical endpoint, the 'acceptance criteria' are primarily related to maintaining the performance of the predicate device and ensuring the modifications (like the microfuse) do not negatively impact its functionality.

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

The document primarily describes bench testing. It does not specify sample sizes in terms of human patients or clinical data. Instead, it refers to tests on the device components (microfuse, pumps, dressings) in simulated environments. For example, "all of the dressings" in wound model testing implies a sample of dressings, but the exact number isn't quantified. The data provenance is laboratory/bench testing. No country of origin for clinical data is applicable as no clinical data is presented. The tests are prospective in the sense that they were conducted specifically for the 510(k) submission to evaluate the modified device.

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)

Not applicable. The document describes bench testing of mechanical and electrical performance, not a study requiring expert clinical assessment to establish ground truth.

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

Not applicable. There is no clinical test set or need for adjudication in the context of the bench tests described.

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. This is a non-clinical evaluation of a modified Negative Pressure Wound Therapy System, not an AI-assisted diagnostic device.

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

Not applicable. This is a medical device for wound therapy, not an algorithm. The performance described is for the device operating as intended.

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

For the bench tests, the "ground truth" is based on established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993-1, ISO 10993-7) and the pre-defined performance characteristics of the predicate device. The tests aim to demonstrate that the modified device's performance meets these objective criteria in simulated environments.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning/AI device.

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

Not applicable. There is no training set for this device.

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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. Examples of 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 in both a hospital and homecare setting.

PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphragm, 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 PICO Single Use Negative Pressure Wound Therapy System's acceptance criteria and studies focused on demonstrating biocompatibility and electrical/software safety rather than a comparative effectiveness study with human readers or standalone algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not detail a "test set" in the context of clinical performance or algorithm evaluation with human data. The tests described are primarily non-clinical bench and lab-based studies focused on biocompatibility and safety.

• Biocompatibility Tests: These involved laboratory samples of the PICO dressing and secondary fixation strips. The specific "sample sizes" (e.g., number of animals for sensitisation, number of cell cultures for cytotoxicity) are not explicitly stated in the summary, but the methods were conducted in accordance with ISO 10993 standards.
• Electrical, Electromagnetic, and Software Tests: These involve testing the physical device and its software, not human data.

Data Provenance: Not applicable in the context of human data. The biocompatibility tests are lab-based, not involving human subjects or real-world clinical data from specific countries.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The "ground truth" for these non-clinical tests is established by adhering to international recognized standards (e.g., ISO, IEC protocols) and achieving predefined outcomes (e.g., "non-sensitising," "Grade 0 Cytotoxicity," compliance with electrical safety limits). These are objective measurements rather than expert consensus on a subjective output.

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective measurements against established standards (biocompatibility, electrical safety), an adjudication method for conflicting expert opinions is not relevant.

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 as this device is a medical device (Negative Pressure Wound Therapy System), not an AI-driven diagnostic or interpretative tool designed to assist human readers. The regulatory submission focuses on the safety and efficacy of the physical device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The PICO system is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is defined by:

• International Standards: Compliance with specific ISO (e.g., 10993 for biocompatibility) and IEC (e.g., 60601 for electrical safety, 62304 for software) standards.
• Objective Laboratory Measurements: Results from cytotoxicity assays, sensitization tests (e.g., Guinea Pig Maximisation Test), irritation tests, and residual analyses, all yielding quantitative or qualitative results that are evaluated against pre-defined acceptable limits within the standards.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data.

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

Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data or associated ground truth.

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