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The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudates via the application of negative pressure wound therapy.

The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) System. The ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) system consists of:

• ACTIV.A.C. TM Therapy Unit (the subject of this submission)
• disposable canister which collects wound exudate
• a wound interface dressing
• . semi-occlusive wound drape
• sensing pad and lumen

The ACTIV.A.C. ™ Therapy Unit is a portable, battery-powered, reusable, software-controlled therapy unit that can provide continuous or intermittent applications of negative pressure to the wound bed in the selectable range of -25mmHg to -200mmHg. The ACTV.A.C.™ Therapy Unit is designed for the application of Negative Pressure Wound Therapy in the home, acute or extended care setting. The open cells of the dressing, to which the therapy unit is connected via pad and lumen, enables distribution of the negative pressure across the surface of the wound bed, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.

Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that contains preset therapy settings based on wound type, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.

The provided text describes the ACTIV.A.C.™ Therapy Unit, a negative pressure wound therapy (NPWT) system. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to pre-existing devices (predicates K063692 and K120033) rather than defining specific, quantifiable acceptance criteria with numerical performance targets in the context of a "device performance" column. Instead, the "reported device performance" is described as the device functioning "as intended" and all test results being "as expected."

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

The document describes non-clinical testing for the ACTIV.A.C.™ Therapy Unit. It does not refer to a "test set" in the context of patient data or clinical trials. The tests conducted are:

• Conformance to 60601-1 standards: This likely involved laboratory testing of the device itself.
• Software assessment: This involved reviewing the software against FDA guidance.
• Negative Pressure Maintenance System Test: This involved testing the device's ability to maintain negative pressure and manage fluid.
• Extreme Environmental Storage Conditions test: This involved subjecting the device to various temperatures.

Therefore, there is no patient-specific sample size for a test set, and no data provenance in terms of country of origin or retrospective/prospective study design as these were non-clinical, in-vitro tests of the device's engineering performance.

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

Not applicable. As described above, this was non-clinical engineering and software testing. Ground truth in this context would be defined by engineering specifications and regulatory standards, not by expert medical opinion on patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no need for adjudication of patient data.

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

No. This document describes a 510(k) submission for a medical device (ACTIV.A.C.™ Therapy Unit), which focuses on demonstrating substantial equivalence through non-clinical performance and technological characteristics. It does not involve a multi-reader multi-case (MRMC) study or evaluate the improvement of human readers with or without AI assistance. The device is a physically applied NPWT unit, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. The ACTIV.A.C.™ Therapy Unit is a hardware and software system, not an algorithm. The software is integral to the device's function (e.g., controlling pressure, alarms). Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests described would be based on:

• Engineering specifications and design requirements: For tests like negative pressure maintenance and environmental conditions.
• Regulatory standards: Specifically, IEC 60601-1 for basic safety and essential performance.
• FDA guidance documents: For software assessment.

This is primarily engineering and regulatory compliance-based ground truth, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set of data. The "software" mentioned refers to the operational software embedded in the device, not an AI model trained on a dataset.

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

Not applicable, as there is no training set for a machine learning algorithm.

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The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Motion NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Liberty NPWT system is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The Invia Gauze Dressing Kit with FitPad in comunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:

• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts
• Closed surgical incisions

The labeling of the Invia Motion Negative Pressure Wound Therapy (NPWT) System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad has been modified to expand the indications for use to include closed surgical incisions. When used on closed surgical incisions, the devices are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

INVIA MOTION NPWT SYSTEM
The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Motion suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.

INVIA LIBERTY NPWT SYSTEM
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.
A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.

INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD
The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.

This document describes the premarket notification for the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems, and their associated Foam and Gauze Dressing Kits with FitPad. The submission seeks to expand the indications for use to include closed surgical incisions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a "table of acceptance criteria" with numerical targets and corresponding device performance values in a typical format for a medical device study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implied by demonstrating substantial equivalence to predicate devices for the new expanded indication (closed surgical incisions) and by successful completion of various non-clinical performance and safety tests.

The "reported device performance" is described qualitatively through these tests.

Implied Acceptance Criteria and Reported Device Performance:

• A steady rise of negative pressure at test onset to the set vacuum level.
• A uniform and constant vacuum level throughout the test period.
• The vacuum level corresponds to the selected set vacuum level of the pump.
• The volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister.
• Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model.
• Compared equivalently to the predicate ActiV.A.C. Therapy Unit (K120033) for use on closed surgical incisions. |
  | Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices for the expanded indication. | The non-clinical tests described demonstrate that the device is substantially equivalent to the predicate devices for the new indication of closed surgical incisions. The differences do not introduce new intended uses or raise different questions of safety and effectiveness. |
  | Functional Equivalence: Non-significant changes to components (software, hardware, labeling, sterile packaging) maintain performance. | Software verification and validation testing were completed for non-significant changes. |

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 non-clinical performance testing using simulated wound models.

• Sample size: Not explicitly stated as a numerical count of "cases" or "patients." Performance testing was conducted on "a closed surgical incision model and simulated wound exudates." The typical approach for such tests involves a sufficient number of runs or samples to demonstrate consistent performance within the system. Specific sample sizes for individual tests (e.g., bioburden, materials testing) are not detailed.
• Data Provenance: The studies are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human patients. Therefore, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply. The submitter is Medela AG, based in Baar Zug, Switzerland, implying the tests were likely conducted under their quality system, possibly internally or at contract labs.

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)

This is a non-clinical submission, and no ground truth established by medical experts (like radiologists) is relevant or mentioned. The "ground truth" for the performance testing cited would be engineering specifications and validated test methods to measure parameters like pressure, flow, and fluid removal accuracy against established standards and predicate device performance.

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

Not applicable. As a non-clinical performance study using simulated models, there is no need for adjudication by human experts as would be required for clinical image interpretation or diagnostic performance studies. The "results" are objective 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

Not applicable. The submission is for Negative Pressure Wound Therapy (NPWT) systems and dressings, which are physical medical devices, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its mechanical and functional design.

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

For the non-clinical performance testing, the "ground truth" is based on:

• Engineering Specifications: The device's predetermined operational parameters (e.g., set vacuum levels, flow rates).
• Validated Test Methods: Standardized procedures for measuring device performance (e.g., pressure output, fluid removal volume).
• Predicate Device Performance: Direct comparison to the established performance characteristics of the legally marketed predicate devices (ActiV.A.C. Therapy Unit K120033).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that uses training sets.

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

Not applicable, as no training set was used.

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The Prevena Plus Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment, and removing exudate via the application of negative pressure wound therapy.

The Prevena Plus Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The system is applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The Prevena Plus Incision Management System consists of: A Prevena Dressing (Prevena Plus Peel & Place Dressing or Prevena Plus Customizable Dressing) and One of the following KCI Negative Pressure Wound Therapy Units: Prevena Plus 125 Therapy Unit*, ActiV.A.C. Therapy Unit, V.A.C. Freedom Therapy Unit, InfoV.A.C. Therapy Unit, V.A.C. ATS Therapy Unit, V.A.C. Ulta Therapy Unit. * The Prevena Plus 125 Therapy Unit is a slightly modified V.A.C.Via Therapy Unit, previously cleared under K132741, that provides continuous negative pressure at -125mmHg only. The V.A.C.Via Therapy Unit serves as a reference device for 510(k) K153199.

This document describes a 510(k) premarket notification for the Prevena Plus Incision Management System. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on showing that the new device is as safe and effective as a previously approved device, often through a comparison of technological characteristics and performance data, rather than extensive clinical trials for new medical devices.

Therefore, the typical acceptance criteria and study design elements you'd find for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable in the same way here. This is a conventional medical device submission focused on physical and functional equivalence to an existing device.

Here's an interpretation based on the provided text, addressing your points where possible within the context of a 510(k) submission for a non-AI device:

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

For this 510(k) submission, the "acceptance criteria" revolve around demonstrating the new device performs equivalently to the predicate device in key functional areas. The "reported device performance" is the result of non-clinical bench testing.

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

• Sample Size: The document does not specify a "sample size" in the context of a patient-based test set, as this was a non-clinical bench study. The "test set" consisted of simulated wound beds and the components of the device (Prevena Plus Customizable Dressing, Prevena Plus 125 Therapy Unit, tubing set).
• Data Provenance: The studies were non-clinical tests (bench testing/simulations) conducted to support the substantial equivalence determination. The country of origin is not explicitly stated, but the submission is from KCI USA, Inc. in San Antonio, TX, suggesting the testing was likely conducted in the US or by KCI-affiliated entities. It is prospective in the sense that the testing was performed to support this specific submission.

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. As a non-clinical bench study, ground truth in terms of expert clinical assessment is not established in the same way as an AI/ML diagnostic or prognostic device. The "ground truth" for the bench tests would be the established engineering specifications and validation methods for negative pressure delivery and alarm functionality.

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

• Not applicable. This was a non-clinical bench study testing physical and functional specifications. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., radiology images) by multiple experts.

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/ML diagnostic or interpretive device that would involve human readers. Therefore, an MRMC study is not relevant.

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

• Not applicable directly in the AI/ML sense. However, the performance data presented is essentially "standalone" device performance, as it evaluates the device's ability to meet its technical specifications (-125 mmHg pressure, alarm function) without human patient interaction as part of the primary measurement.

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

• For the non-clinical tests, the "ground truth" would be the engineering specifications and established validation protocols for negative pressure wound therapy systems. This includes:
  • Target negative pressure level (-125 mmHg).
  • Duration of therapy (7 days).
  • Conditions for testing (simulated wound bed, wet conditions, maximum air leak).
  • Functional requirements for alarms (leak, blockage, full canister).

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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SNaP System with SNaP Cartridge (60cc):

The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

SNaP System with SNaP Plus Cartridge (150cc):

The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, singleuse, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is based on the concept of forced expansion of volume to produce negative pressure at the wound bed or at the closed incision, utilizing dedicated constantforce springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. It is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician.

This document is a 510(k) premarket notification for a medical device called the "SNaP® Wound Care System." It describes modifications to an already cleared device, not a new device requiring a full efficacy study. As such, the information typically found in a study proving a device meets acceptance criteria, such as detailed clinical study results with specific sample sizes, ground truth establishment, adjudication methods, or multi-reader multi-case studies, is not present here.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical, bench testing. The acceptance criteria are essentially met by showing the modified device performs similarly to the predicate devices and existing specifications, and that the changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The testing was nonclinical (bench testing), not a clinical trial with a "test set" of patients. The sample sizes would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical trial data. This refers to in-house laboratory testing of the device components and system.

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

• Not applicable. This was a nonclinical submission. "Ground truth" in this context would refer to the established performance requirements and specifications for the device, likely determined by engineering and regulatory standards, and internal quality control. No external experts or medical professionals were involved in establishing "ground truth" for nonclinical bench testing results presented here.

4. Adjudication Method for the Test Set

• Not applicable. This was a nonclinical submission. Adjudication methods are typically relevant for clinical studies where expert consensus or review is needed to classify findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. An MRMC study was not done. This is a nonclinical submission for a wound care system, not an imaging device requiring human reader interpretation.

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

• Not applicable. This is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic tool.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: For nonclinical bench testing, the "ground truth" is defined by established engineering design specifications, internationally recognized standards for medical devices (e.g., for materials, sterilization, pressure levels, and biocompatibility), and internal test protocols. The device's performance is compared against these predetermined specifications.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve an AI algorithm that requires a "training set."

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

• Not applicable. As there is no AI algorithm or training set, this question is irrelevant to this submission.

Summary of the Study (Bench Testing):

The "study" described in the 510(k) notification is a series of nonclinical, bench tests designed to demonstrate that minor design changes and additions to the SNaP Wound Care System do not alter its safety or effectiveness compared to its predicate devices. The modifications included a simplified reset feature, minor material/design changes for commercial scale production, and the addition of a Long Dressing Kit and a SNaP Plus Strap.

The testing covered:

• Device design verification at baseline and after 2-year accelerated aging.
• User requirements verification for the SNaP Plus Strap.
• Verification of 7-day use for the SNaP cartridges.
• Sterilization validation for the new dressing kit.
• Biocompatibility testing.
• Packaging and shelf life testing.

No clinical testing was performed. The collective results of these nonclinical tests formed the basis for concluding that the device meets established specifications and is substantially equivalent to the predicate devices, not raising new questions concerning safety or effectiveness. The removal of a contraindication for use on actively infected wounds was supported by comparison to other NPWT products and published clinical evidence (though not clinical evidence specifically generated for this submission).

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