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PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are 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)
• Venous Leg Ulcers - PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
• Flaps and grafts
• Closed surgical incisions

PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.

The PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems consist of:
• PICO Pump
• Batteries
• PICO Dressing (s)
• Instructions for Use
• Fixation Strips

PICO Fluid Management Packs consist of 5 individually packaged PICO dressings designed for use with PICO devices.

PICO 7 and PICO 14 are canister-free single use Negative Pressure Wound Therapy Systems and use an absorbent dressing connected to the PICO pump via a tubing and port.

Wound exudate is managed by PICO dressing using a combination of absorption and evaporation. The PICO pump provides the additional benefit of -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy to the wound.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study designed to prove the device meets specific performance criteria.

The document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K202157) for an expanded Indication for Use: the use of PICO in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of the device itself (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device), cannot be extracted from this document.

The document does include:

• Clinical information (Page 6-7): References a Randomized Controlled Trial (RCT) by Kirsner et al. (2019) and a Cochrane Review by O'Meara et al. (2012) to demonstrate the safety of PICO when used with compression therapy for Venous Leg Ulcers, especially regarding adverse events (AEs). This is a safety comparison, not a performance study against acceptance criteria.
  • Study Design: Randomized, multi-centre, open-label, controlled trial.
  • Sample Size: 164 patients for safety analysis. 101 subjects with venous leg ulcers (VLU) and 60 subjects with diabetic foot ulcers were in the ITT population (n=161 total). 80 received PICO treatment, of which 51 (63.8%) had a VLU.
  • Data Provenance: Not specified, but likely multi-center, implying various locations. Retrospective or prospective is not explicitly stated, but RCTs are typically prospective.
  • Ground Truth: The study evaluated adverse events and their frequency, comparing them to historical controls. The "ground truth" here is the occurrence and classification of adverse events by clinical observation as per the study protocol.
  • Acceptance Criteria (Safety): The conclusion drawn is that "PICO used in conjunction with compression therapy does not generate any increased frequency in the number or severity of AEs in patients compared to compression therapy alone." This acts as a comparative safety criterion rather than a performance metric.
  • Reported Device Performance (Safety): Percentage of subjects reporting a device-related AE was 13.7% for PICO + 4-Layer Bandage (4LB) group, compared to 31.9% for historical 4LB control.
  • Experts, Adjudication, MRMC studies, Standalone Performance, Training Set: These are not relevant to the safety study presented in the document, which focuses on device-related adverse events in patients, not on an algorithmic or AI performance.

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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 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System. PICO 14 Single Use Negative Pressure Wound Therapy System. and the PICO Fluid Management Pack are 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 7, PICO 7 Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use in both a hospital and homecare setting.

All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices.

The provided text is a 510(k) premarket notification for a medical device, specifically the PICO Single Use Negative Pressure Wound Therapy System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study on its performance in treating wounds.

Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria (such as sample size, expert adjudication, MRMC studies, ground truth establishment for training, etc.) is not present in this type of regulatory submission. The document explicitly states:

"Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence."

Instead of a new clinical performance study, the document focuses on:

• Comparison of Technological Characteristics: Demonstrating that the subject device's features, indications for use, environment of use, patient population, materials, sterilization methods, biocompatibility, pump type, and electrical safety testing methods are the same as the predicate device.
• Minor Changes and Supporting Data: Addressing specific minor changes in the device (updated magnet warning text, removal of pump warning label) and providing additional data to support these changes. This additional data includes:
  • Bench testing: For magnetic field strength.
  • Analysis of postmarket surveillance: Including a systematic literature review on IMDs and magnetic interference, and a review of MAUDE database and company complaint data.
  • Risk analysis: Updating the risk assessment based on the above.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document does not present a table of acceptance criteria in the traditional sense of a clinical trial (e.g., Sensitivity X%, Specificity Y%). Instead, the "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate device for various technical and clinical characteristics. The "performance" is primarily demonstrated by showing that the characteristics are identical or that any changes do not raise new questions of safety or effectiveness.

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

• Test Set (for the current K202157 submission):
  • Magnetic Field Testing: This was bench testing, not involving human subjects. The sample size for devices tested is not specified, but it implies a measurement on the PICO Family pumps.
  • Post Market and Risk Analysis: Reviewed over 60,000 records from the MAUDE database (USA, retrospective) and Smith +Nephew PICO devices complaint data (provenance not specified, but likely global, retrospective).
• Provenance: MAUDE data is from the United States. The literature review is not geographically specified but typically covers international publications. Smith +Nephew complaint data is likely global. All are retrospective analyses.
• The document states that clinical performance data was provided in previously cleared 510(k)s. This suggests the initial clinical data was obtained for those initial clearances, not for this specific submission which focuses on minor labelling changes and supporting evidence for those changes through non-clinical 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)

• Not applicable to this 510(k) submission. This is not a study assessing diagnostic or clinical performance against expert ground truth. The "ground truth" for the current changes is based on:
  • Bench testing results (magnetic field strength)
  • Regulatory requirements (for labeling updates)
  • Analysis of real-world adverse event data (MAUDE database, company complaints) and scientific literature review. This analysis would have been performed by internal regulatory/safety/scientific experts, but the specifics of their number or qualifications are not provided as it's not a reader study.

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

• Not applicable. This document describes a substantial equivalence claim for a physical medical device, not an AI/imaging algorithm requiring adjudication of interpretations. The analysis of post-market data and literature would involve methods of synthesizing evidence and risk assessment, but not "adjudication" in the context of clinical interpretation.

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 device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its clearance.

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

• Not applicable. This is a physical medical device, not software or an algorithm with standalone performance metrics.

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

• For the magnetic field testing, the "ground truth" is measured physical properties based on calibrated equipment.
• For the post-market surveillance and risk analysis, the "ground truth" is derived from:
  • Reported adverse events/complaints (MAUDE database, company data). These are real-world reported events, which serve as evidence of actual outcomes (or lack thereof).
  • Published scientific literature on magnetic interference with implantable medical devices. This represents the established scientific understanding and reported cases in medical literature.

8. The sample size for the training set

• Not applicable. This device does not use machine learning where a "training set" would be relevant.

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

• Not applicable.

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PICO 14 is indicated for patients who would benefit from a suction device (NPWT) as it may promote would 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 14 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

PICO 14 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.

The provided text describes the PICO 14 Single Use Negative Pressure Wound Therapy System and its substantial equivalence to the predicate device, PICO 7. However, the information presented primarily focuses on demonstrating equivalence through bench testing and a clinical study on patient outcomes rather than a traditional setup of acceptance criteria and a study dedicated to proving the device meets those specific criteria in a formal, AI-centric evaluation.

The device itself is a powered suction pump for wound therapy, not an AI/ML-driven diagnostic or treatment device, which explains the absence of some of the requested AI-specific information.

Here's an attempt to extract and present the information as requested, aligning it as closely as possible to the nature of the provided text:

Acceptance Criteria and Device Performance Study for PICO 14 Single Use Negative Pressure Wound Therapy System

The PICO 14 device is an electro-mechanical pump system and does not appear to involve AI/ML. Therefore, typical AI-specific acceptance criteria (like sensitivity, specificity, AUC) and an AI-specific study structure are not applicable to the information provided. Instead, "acceptance criteria" here refers to the demonstrated performance aspects that allow the device to be considered substantially equivalent and safe/effective for its intended use. The "study" refers to the non-clinical bench tests and the clinical evidence presented for the device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a medical device clearance and not an AI/ML product, the "acceptance criteria" are derived from the demonstrated functionalities and safety profiles required for its intended use and comparison to the predicate device.

2. Sample Size and Data Provenance for the Test Set (Clinical Evidence)

• Sample Size for Clinical Evidence:
  • Total patients followed: 3,159
  • Patients using PICO device: 917
  • PICO patients with wound depths > 2 cm: 409 (comprising 233 DFUs, 18 PUs, 147 dehisced surgical wounds, and 11 VLUs).
  • Patients discontinuing PICO: 32 out of 917 (2.8%).
• Data Provenance: Retrospective, from two community care access centers.
• Country of Origin: Not explicitly stated but "community care access centers" suggests a real-world setting. Assuming within the country where the company operates or where the study was managed, which might be the UK (Smith & Nephew Medical Limited is in Hull, UK) or another location.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

The clinical evidence provided appears to be an observational study of patient outcomes rather than a ground truth establishment by experts for a specific test set in the context of an AI device.

• Number of Experts: Not specified. The study involved patient care in community care access centers, suggesting healthcare professionals (e.g., nurses, doctors) were involved in patient admission, care, and data recording including wound depth and healing.
• Qualifications of Experts: Not specified, but implied to be healthcare professionals involved in wound care. Clinicians decided if exudate rate increased beyond indicated levels.

4. Adjudication Method for the Test Set

Not applicable. The clinical study was an observational study of patient outcomes, not an evaluation where expert adjudication of individual cases was performed to establish a definitive ground truth for device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a physical therapy system, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases with and without AI assistance. The clinical evidence compared patient outcomes with PICO vs. non-PICO treatment.

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

Yes, in a sense, the functionality of the device itself (the PICO 14 system delivering negative pressure) was evaluated in "standalone" bench tests, demonstrating its mechanical and software performance over 14 days and for deep wounds. This is not "algorithm only" in the AI sense, but rather the device's inherent function.

7. The Type of Ground Truth Used (Clinical Evidence)

The "ground truth" for the clinical evidence was based on patient outcomes data (time to healing, number and duration of dressing changes, and adverse events) and clinically observed wound parameters (wound depth, exudate levels, and clinicians' decisions).

8. Sample Size for the Training Set

Not applicable. The PICO 14 is an electro-mechanical device. There is no mention of an AI/ML algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would be engineering and design iterations.

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

Not applicable, as there is no AI/ML component or "training set" described for this medical device in the provided text.

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