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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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The SNaP® Wound Care System is indicated for patients who would benefit from wound 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, single-use, 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 able to generate negative pressure to allow for the removal of wound exudate/fluid from a wound bed or from a closed incision, utilizing dedicated constant-force springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. This 510(k) premarket notification is for design modifications to the 60cc SNaP Cartridge component of the predicate SNaP Wound Care System, in order to introduce a larger capacity 150cc cartridge available with 125mmHg pressure setting.

The provided document is a 510(k) premarket notification for the SNaP® Wound Care System, specifically for a design modification introducing a larger capacity cartridge. This is not typically a document that includes detailed acceptance criteria and a comprehensive study report in the same way a clinical trial or AI device validation would.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K132080). This means the manufacturer is showing that the modified device is as safe and effective as the existing one, not necessarily proving that it meets specific, quantifiable performance criteria against a disease outcome with a new, standalone study.

However, I can extract the relevant information from the document to construct an answer based on its content, acknowledging the limitations of a 510(k) summary.

Acceptance Criteria and Study for SNaP® Wound Care System (K142272)

The SNaP® Wound Care System's acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a predicate device. The primary performance criteria revolve around the device's ability to generate and maintain negative pressure and manage exudate, aligning with its intended use in wound therapy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of cartridges tested for pressure, number of dressing kits for pressure transmission). It generically states "All necessary bench testing was conducted."
• Data Provenance: The studies were retrospective in the sense that they were conducted by the manufacturer, Spiracur Inc., in support of their 510(k) application. The data provenance is internal to the manufacturer in sunnyvale CA USA, as it is bench testing to demonstrate equivalance. There is no information about global or specific country of origin for the data beyond the manufacturer's location.

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

• This information is not applicable as the studies described are bench tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here is based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

• Not applicable. Bench testing involves objective measurements against predefined engineering specifications, not subjective human assessments requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical medical device (Negative Pressure Wound Therapy system), not an AI algorithm for diagnostic or prognostic purposes. Therefore, the concept of human readers and AI assistance is not relevant to this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study

• Not applicable. This document describes a physical medical device, not an AI algorithm. The performance described is the standalone performance of the device itself (its mechanical and material properties).

7. Type of Ground Truth Used

• The ground truth used for the bench testing was based on engineering specifications, regulatory requirements (e.g., biocompatibility standards), and the established performance characteristics of the predicate device. For example, the "ground truth" for negative pressure generation was 125mmHg ± 17.5mmHg.

8. Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning. The design and modification of the device are based on engineering principles and previous product iterations, not data-driven machine learning training.

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

• Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in that context. The design process for this medical device relies on established engineering and manufacturing standards.

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The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, 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.

The SNaP® Wound Care System ("SNaP System") is an existing (K081406, K111393, K112341, K 113032) non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The proposed SNaP Wound Care System will have the same indication for use as the predicate device, the SNaP Wound Care System (K113032). In addition, Spiracur has added the SNaP® Bridge Dressing Kit ("SNaP Bridge Dressing") and SNaP® SecurRing" Hydrocolloid ("SNaP SecurRing") to the SNaP Dressing Kit product family.

This document is a 510(k) summary for the SNaP® Wound Care System, focusing on modifications and additions to the existing device and dressing components. It primarily addresses substantial equivalence to predicate devices and does not contain detailed acceptance criteria and study results in the format requested for proving performance.

Based on the provided text, the device in question is the SNaP® Wound Care System, described as a "Non-powered suction apparatus device intended for negative pressure wound therapy." The submission is for modifications and additions (SNaP® Bridge Dressing Kit and SNaP® SecurRing™ Hydrocolloid) to an already cleared device, along with labeling changes.

Therefore, much of the requested information regarding a study that proves the device meets specific acceptance criteria is not present in this 510(k) summary, as the submission focuses on demonstrating substantial equivalence through bench testing rather than a clinical performance study with predefined acceptance criteria for a new device.

However, I can extract the information that is present:

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

The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria in a table format. Instead, it describes various "bench testing" categories performed to ensure "conformance to design specifications" and "substantial equivalence." The performance is generally described qualitatively as being "comparable to the predicate device."

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 mentions "bench testing" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for any of the tests conducted.

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 information is not provided. The text describes bench testing, which typically does not involve human expert ground truth establishment in the way clinical studies with diagnostic devices do.

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

This information is not provided. As the testing is bench-based, an adjudication method for human readers would not be applicable.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any AI assistance. The device is a non-powered wound care system, not a diagnostic or AI-powered device.

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

There is no mention of an algorithm or standalone algorithm performance. The device is a physical medical device.

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

For the bench testing described, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The document states that testing was done "to ensure conformance to design specifications" and to assess "ability... to deliver negative pressure wound therapy comparable to the predicate device." No clinical ground truth (like pathology or outcomes data) is mentioned for these bench tests.

8. The sample size for the training set

There is no mention of a training set. This document describes the submission for a physical medical device undergoing bench testing for substantial equivalence, not an AI or diagnostic algorithm that would require a training set.

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

As there is no mention of a training set, this information is not applicable and not provided.

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The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious naterial 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.

The SNaP® Wound Care System ("SNaP System") is a portable, non-powered suction device intended for wound management via application of negative pressure to the wound bed for removal of fluids, including wound exudate, irrigation fluids and infectious materials.

The provided text is a 510(k) Premarket Notification for the Spiracur SNaP® Wound Care System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets said criteria.

The 510(k) filing states:
"The SNaP System is an existing device to which no design changes have been made as a result of the labeling changes. As such, no further testing has been conducted."

This means that for this specific 510(k) application (K113032), no new study was performed to establish acceptance criteria or demonstrate device performance against new criteria. The application is based on substantial equivalence to previously cleared devices and merely expanded the indications for use based on existing data or predicate device similarities.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study, as this information is not present in the provided text.

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The SNaP® Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, 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 or pressure), surgically closed incisions, flaps and grafts.

The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, 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 or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.

This document describes a Special 510(k) premarket notification for the SNaP® Wound Care System, focusing on a minor design modification. Due to the nature of a Special 510(k) and the specific information provided, a detailed performance study with acceptance criteria in the typical sense for a new diagnostic device is not presented. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device through bench testing.

Here's an analysis based on the provided text:

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

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

The document mentions "Bench testing" and "Biocompatibility testing." For bench testing, typical sample sizes would involve a certain number of manufactured units or material samples. However, specific sample sizes for the bench tests are not provided in the supplied text. Similarly, data provenance (country of origin, retrospective/prospective) is not specified. Biocompatibility testing usually follows ISO standards, which dictate the types and number of samples.

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 not applicable in the context of this Special 510(k). The evaluation is based on bench testing and biocompatibility assessments related to the physical performance and material properties of the device, not on diagnostic accuracy requiring expert interpretation of results. Therefore, there are no "experts to establish ground truth" in the clinical diagnostic sense. The "ground truth" here is adherence to design specifications and comparable performance to the predicate device, assessed through engineering and material science testing.

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

Not applicable. As noted above, this submission focuses on bench testing and biocompatibility, not clinical diagnostic performance requiring adjudication of interpretations.

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 non-powered suction apparatus for negative pressure wound therapy, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is outside the scope of this submission.

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

Not applicable. This device is a medical device for wound therapy, not an algorithm.

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

The "ground truth" for this submission is related to the engineering specifications and performance characteristics of the device, as well as biocompatibility standards. This is established through:

• Design specifications: The device is evaluated to ensure conformance to its own design specifications.
• Predicate device performance: The modified device's ability to deliver negative pressure is compared to that of the already cleared predicate device (K111393). The established performance profile of the predicate serves as a benchmark for "ground truth" comparability.
• Biocompatibility standards: The materials used are tested against established biocompatibility standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a medical device, not a machine learning algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

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The CI-SNaP™ Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.

The CI-SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including exudate, irrigation fluids and infectious materials. The CI-SNaP Wound Care System is designed to provide active wound treatment to help promote healing in surgical incisions that continue to drain following sutured or stapled closure. The CI-SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The CI-SNaP™ Wound Care System is used in conjunction with the CI-SNaP™ Dressing Kit.

This 510(k) premarket notification for the CI-SNaP™ Wound Care System (K111006) does not contain specific acceptance criteria or an analytical study demonstrating device performance against such criteria in the way a diagnostic AI/ML device submission would.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SNaP™ Wound Care System, K081406). The testing described is primarily design verification rather than a clinical effectiveness study.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that bench testing was done to "assess the ability to deliver negative pressure wound therapy." However, it does not specify what negative pressure range it must deliver, for how long, or with what accuracy/consistency, which would be typical acceptance criteria for performance. Similarly, while biocompatibility testing was done, the specific acceptance criteria (e.g., passing ISO 10993 cytotoxicity, sensitization, irritation tests) are not detailed.

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

• Sample Size: Not specified. The "bench testing" would likely involve a sample of manufactured devices, but the number is not provided.
• Data Provenance: The device is a physical, non-powered suction apparatus. The testing described is non-clinical bench testing rather than testing on patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

• Not applicable. This device is a mechanical negative pressure wound therapy system, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The efficacy is based on the physical application of negative pressure.

4. Adjudication Method for the Test Set

• Not applicable. As there's no "ground truth" derived from expert consensus on a test set (e.g., imaging, clinical diagnoses), no adjudication method is relevant.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret cases (e.g., radiology images) and compare performance with and without AI assistance. This is a non-powered wound care device.

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

• Not applicable. This device does not involve an algorithm. It's a mechanical device.

7. The Type of Ground Truth Used

• The "ground truth" for this type of device is its physical performance specifications (e.g., ability to generate and maintain negative pressure, fluid removal capacity, biocompatibility, sterility). The testing described aims to verify these engineering and safety specifications through bench testing and biocompatibility assessments, rather than comparing against a clinical "ground truth" like pathology or patient outcomes for a diagnostic claim. The "intended use" is based on the predicate device's established efficacy.

8. The Sample Size for the Training Set

• Not applicable. This device does not utilize AI/ML and therefore does not have a "training set."

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

• Not applicable. As there is no training set.

In summary: The provided 510(k) notification for the CI-SNaP™ Wound Care System focuses on demonstrating substantial equivalence to a predicate device through engineering design verification and biocompatibility testing. It does not involve the types of clinical studies, expert-adjudicated ground truth, or AI/ML specific evaluations that would be described for a diagnostic device. The acceptance criteria are implicitly tied to the device's design specifications and its ability to perform its mechanical function (delivering negative pressure and removing exudate) safely and effectively, as demonstrated by bench testing and biocompatibility.

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