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

PICO 7 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 7 was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

The PICO 7 Single Use Negative Pressure Wound Therapy System is intended to promote wound healing by removing low-to-moderate levels of exudate and infectious materials. The device was evaluated against specific acceptance criteria for its performance indicators and safety. The study that proves the device meets the acceptance criteria is detailed in the "Non-Clinical Tests (Bench)" section of the 510(k) summary (pages 6-10).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical (bench) tests. Specific numerical sample sizes for each test are not consistently provided in this summary. For example, "Wound model testing was conducted on PICO 7 Kits (10x20cm and 25x25cm dressings) at low and moderate flow rate..." implies testing was done on multiple kits/dressings but doesn't state the exact number. Similarly for "Dressing Full Indicator" and "Low Battery Indicator" tests, it states "All test results showed...", suggesting multiple tests were carried out, but without giving a precise count.

Data provenance: These are bench tests, meaning they are conducted in a controlled laboratory environment rather than on human subjects. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense.

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

Not applicable. These were non-clinical, bench testing experiments conducted against engineering and performance specifications, not based on expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set:

Not applicable. This pertains to clinical studies often involving expert interpretation of medical images or patient outcomes, not bench testing against pre-defined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This 510(k) summary only describes non-clinical bench testing. MRMC studies are typically for evaluating diagnostic or predictive AI systems in a clinical context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The tests described are for the device's standalone performance, albeit within a simulated or controlled bench environment rather than a clinical human-in-the-loop setting. The device's indicators (dressing full, air leak, low battery) and its physical performance (fluid management, pressure maintenance, noise) are tested "algorithm only" in the sense that their automated function is evaluated.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on pre-defined engineering specifications, performance metrics, and compliance standards. For example:

• Wound model testing: Based on specified fluid flow rates (0.6 and 1.1 g/cm²/24 hours) and negative pressure ranges (-60 mmHg to -100 mmHg).
• Indicator testing: Based on the device correctly activating indicators within specified timeframes or conditions (e.g., "dressing full" within 2 hours, "low battery" for 12 hours).
• Acoustic testing: Based on noise level limits defined by ANSI/AAMI HE75:2009/(R)/2013 (e.g., maximum 35dB LAFmax).
• EMC/Electrical Safety: Compliance with specific IEC and AAMI/ANSI standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical/electronic negative pressure wound therapy system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.

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

Not applicable for the same reason as above.

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PICO 7 is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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 7 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

PICO 7 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, magnet containing 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 7 was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

Based on the provided text, the acceptance criteria and the study proving the device meets them can be summarized as follows:

The device in question is the PICO 7 Single Use Negative Pressure Wound Therapy System.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a formal "acceptance criteria" table with specific quantitative benchmarks for each test. Instead, it describes the conditions under which tests were performed and states that the device "meets the test requirements" or "can be used for their intended purposes." The table below synthesizes the implied criteria and reported performance from the "Non-Clinical Tests (Bench)" section.

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

The document does not specify a numerical sample size for the "test set" in the traditional sense of a clinical trial. The "Non-Clinical Tests (Bench)" section refers to "Wound Model Testing of PICO 7 Kits" with various dressing sizes (10x20cm, 25x25cm, small multisite 15x20cm, large multisite 20x25cm dressings). This suggests a variety of kits were tested.

The data provenance is from bench testing and human factors studies. There is no mention of country of origin for this testing, but the submitting company is "Smith & Nephew Medical Limited" from the "United Kingdom." The tests are described as "Non-Clinical Tests (Bench)" and a "summative study" for human factors, indicating controlled laboratory or simulated environment testing, not retrospective or prospective clinical data from human subjects for performance evaluation.

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

This information is not provided in the given document. The "Non-Clinical Tests (Bench)" section describes physical assessments of fluid management and pressure, which do not typically involve human experts establishing a "ground truth" in the same way clinical image analysis would.

For the "Human Factors" study, "Critical tasks were identified following a risk management process and a series of preliminary testing carried out with the two identified user groups. Healthcare Professionals and Lay Users, in order to optimize the design." While it mentions "Healthcare Professionals," the number and specific qualifications of any experts involved in defining "safe and effective" for the human factors study are not detailed.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human observers or readers interpreting data to establish ground truth. As the primary performance evaluation here relies on bench tests measuring physical parameters (fluid management, pressure), an adjudication method is not applicable or described. For the human factors study, there's no mention of an adjudication process for observed user performance or feedback.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing, human factors, biocompatibility, and electrical safety to demonstrate substantial equivalence, not a comparative clinical effectiveness study involving human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (negative pressure wound therapy system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant in this context. The standalone performance here would refer to the device's ability to maintain pressure and manage fluid, which was assessed in the bench tests.

7. Type of Ground Truth Used

For the "Non-Clinical Tests (Bench)":

• Physical measurements/parameters: The "ground truth" for these tests was defined by the physical test requirements and measured outcomes (e.g., fluid flow rates, pressure ranges, test time percentages). These are objective, quantifiable criteria.

For the "Human Factors" study:

• User observation and feedback against safety/effectiveness criteria: The "ground truth" for determining if the device was "safe and effective for its intended users" was established through the human factors study findings, likely including observed user actions, task completion rates, error analysis, and user feedback against pre-defined usability and safety criteria.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable. As mentioned above, there is no AI algorithm or training set for this device.

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