Search Results

The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

Instillation Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C.ULTA™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Negative Pressure Wound Therapy in the absence of instillation may also be used for:

The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

The management of 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 V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions.

The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.

Here's a breakdown of the acceptance criteria and study information for the V.A.C.ULTA™ Negative Pressure Wound Therapy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for a specific "device." Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and a human factors assessment. The "acceptance criteria" can be inferred from the tests performed and their documented positive results.

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

• Software and Electrical/EMC Testing: The sample sizes for these tests are not explicitly stated in terms of "cases" or "patients." These are typically engineering and laboratory tests performed on the device itself.
• Negative Pressure Performance Testing: The sample size for materials/configurations tested is not explicitly stated. This would involve laboratory testing of the device under various conditions (exudate, leaks, dressing configurations) rather than human subjects.
• Human Factors Engineering Assessment (Test Set):
  • Sample Size: 30 subject nurses and doctors.
  • Data Provenance: This was a prospective study, likely conducted in a controlled environment (e.g., simulation lab, usability testing facility) to assess the new software features. The country of origin is not specified but would presumably be the US given the FDA submission.

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

• For the non-clinical engineering tests (software, electrical, negative pressure performance), the "ground truth" is established by the specifications and standards themselves, and the expertise lies with the engineers and testing personnel who perform and verify compliance. The number and qualifications of these experts are not detailed in this summary.
• For the human factors engineering assessment, the "ground truth" is the ability of all 30 subject nurses and doctors to safely and effectively use the new features. These 30 subjects are the "test set" and implicitly establish the "ground truth" through their direct interaction and feedback, as they represent the intended end-users. Their overarching qualification is that they are healthcare professionals (nurses and doctors) who would typically use such a device. The summary does not specify their years of experience or sub-specialties.

4. Adjudication Method for the Test Set

• Non-clinical Tests: Adjudication is typically based on whether the device meets predefined technical specifications and standards. This would involve internal engineering verification and validation processes, and potentially third-party certification. The summary does not detail a specific adjudication method beyond stating that the device was "certified" and "documented" to meet standards.
• Human Factors Engineering Assessment: The summary states that the assessment "indicated that the new features could be safely and effectively used by all test subjects." This implies a consensus or universal success among the 30 subjects, effectively meaning no formal "adjudication" (like 2+1) was needed if all participants demonstrated safe and effective use. If there were discrepancies or difficulties, a different adjudication mechanism might have been employed, but it is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (Negative Pressure Wound Therapy System) with updated software features. It is not an AI-powered diagnostic or interpretive device, so an MRMC study comparing human readers with and without AI assistance is not applicable here.

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

• Not applicable. The V.A.C.ULTA™ system is a therapy device that involves a human operator to apply and manage the therapy. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that performs a standalone function without human interaction for which standalone performance would be measured. The software updates are for user enhancements and control of the therapy, not an autonomous diagnostic or interpretive function.

7. The type of ground truth used

• Non-clinical performance specifications and user experience.
  • For software, electrical safety, EMC, and negative pressure performance, the ground truth is established by adherence to recognized national and international standards (e.g., AAMI/ANSI ES60601-1, IEC 60601 series) and the internal performance specifications of the device (e.g., specific mmHg ranges for therapy).
  • For the human factors assessment, the ground truth is the demonstrable ability of typical users (nurses and doctors) to safely and effectively operate the device with its new features.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a non-AI medical device. The software updates are for user interface and control enhancements, not for an AI model that requires a "training set" of data.

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

• Not applicable. As there is no AI model requiring a training set, the concept of establishing ground truth for a training set does not apply here.

Ask a specific question about this device

The PREVENA DUO 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 va the application of negative pressure wound therapy.

The PREVENA PLUS DUO 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.

Both the PREVENA DUO™ Incision Management System (with the PREVENA 125 Therapy Unit) and the PREVENA PLUS DUO™ Incision Management System (with the PREVENA PLUS 125 Therapy Unit) are negative pressure wound therapy systems designed for the management of two surgical incisions simultaneously with one PREVENA Therapy Unit. Both systems provide two PREVENA PEEL & PLACE Dressings (which can be for linear incisions up to 13 or 20 cm in length) which are connected to their respective therapy units via a new PREVENA Y-Connector. Therapy is continuously applied to each incision at -125 mmHg for 2 to 7 days. Length of therapy is per surgeon preference.

This document is a 510(k) summary for medical devices, specifically the PREVENA DUO and PREVENA PLUS DUO Incision Management Systems. It details the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, this document does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria in the way typically expected for an AI/algorithm-based medical device.

The devices in question are mechanical negative pressure wound therapy systems, not AI algorithms. Therefore, the questions posed, which are highly relevant to the evaluation of AI/ML-based medical devices, are not directly addressed in this regulatory submission.

Here's a breakdown based on the provided document and the non-applicability of the questions:

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

• Not Applicable. This document pertains to a mechanical device, not an AI/ML algorithm. There are no "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, AUC) for an AI model.
• The document mentions "Negative pressure performance testing indicates that the PREVENA DUO and PREVENA PLUS DUO Incision Management Systems are able to provide negative pressure within specification to each dressing over a 7 day use test and under test conditions of maximum air leak and simulated wound fluid input." This describes engineering performance testing, not clinical or AI performance.

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

• Not Applicable. No computational "test set" in the context of AI/ML is mentioned or used. The performance testing described is engineering/bench testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not Applicable. No ground truth establishment for an AI model is relevant to this device.

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

• Not Applicable. No test set adjudication is relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a mechanical device, not an AI system. No human reader interaction or improvement is relevant.

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

• Not Applicable. There is no standalone algorithm.

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

• Not Applicable. No ground truth for an AI model is used. The "performance data" refers to validation that the device physically generates negative pressure as designed and functions correctly.

8. The sample size for the training set:

• Not Applicable. No training set for an AI model is mentioned or used.

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

• Not Applicable. No training set or associated ground truth establishment is relevant to this device.

In summary: The provided document is a 510(k) submission for a non-AI medical device. The questions are tailored for AI/ML-based devices and thus do not apply to the information presented in this document. The "study" mentioned is "Negative pressure performance testing," which is an engineering validation to ensure the device maintains specified negative pressure and alerts correctly.

Ask a specific question about this device

The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C. Uta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.

The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.

The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.

The provided document is a 510(k) premarket notification for the V.A.C. VeraFlo Cleanse Choice Dressing System, which is a modification of an existing device, the V.A.C. VeraFlo Cleanse Dressing System (K103156). The document focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed clinical study report with extensive statistical analysis of performance metrics. Therefore, some of the requested information, particularly regarding specific performance metrics for acceptance criteria and human superiority studies, is not explicitly available in the document in the format requested.

However, I can extract and infer information about the acceptance criteria and the study conducted to prove the device meets these criteria based on the provided text.

Acceptance Criteria and Reported Device Performance

The document states that the new device is "substantially equivalent" to the predicate device, implying that its performance should be comparable. The key performance aspects tested relate to the mechanical properties of the dressing and its ability to function within the V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System for both negative pressure delivery and instillation.

Study Details

The study described is a bench verification testing and animal testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify exact numerical sample sizes for the bench or animal testing. It states "Bench Verification testing was performed" and "Bench and animal testing have demonstrated."
   • Data Provenance: The document does not explicitly state the country of origin of the data. Given KCI USA, Inc. is based in San Antonio, Texas, it is highly likely the testing was conducted in the USA or by labs commissioned by them. The studies are prospective in nature, as they were conducted to verify the performance of the new device configuration.

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

   • This type of verification study for a device modification (dressing configuration) typically relies on engineering specifications and established biological response models, rather than expert human interpretation of images or patient outcomes for "ground truth." The "ground truth" here is adherence to mechanical and functional specifications derived from the predicate device's performance and general wound healing principles. Therefore, it's unlikely a panel of experts established "ground truth" in the way it would for AI/diagnostic studies. Engineers and scientists involved in the testing would have evaluated the results against pre-defined success criteria.

3. Adjudication method for the test set:

   • Not applicable in the context of this type of engineering and animal testing. Adjudication methods like "2+1" are relevant for expert consensus in diagnostic or clinical trial settings. Here, data would be analyzed against quantitative or qualitative pass/fail criteria.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This study concerns a medical device, specifically a wound dressing system, not an AI or diagnostic imaging system that would involve human readers or AI assistance in interpretation.

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

   • Not applicable. This is a physical medical device, not a software algorithm.

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

   • The "ground truth" for the test set was based on engineering specifications and functional performance criteria derived from the predicate device and established medical device standards. For instance, the tensile strength has a hard numerical "ground truth" (≥230kPa). For negative pressure and instillation distribution, the ground truth is successful operation mimicking the predicate device in controlled bench and animal models.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning system that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set.

Ask a specific question about this device

The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate yia the application of negative pressure wound therapy.

The Prevena 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 Prevena 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 Incision Management System consists of: A Prevena Dressing (Prevena Peel & Place Dressing or Prevena Customizable Dressing and A source of negative pressure wound therapy, which may be one of the following KCI therapy units with its associated canisters: Prevena 125 Therapy Unit ActiV.A.C. Therapy Unit V.A.C. Freedom Therapy Unit InfoV.A.C. Therapy Unit

The provided text describes the Prevena Incision Management System and its substantial equivalence to predicate devices. It presents a "Prevena Dressing Pressure Manifold Test" as the primary performance data, but the description of this test does not align with the typical structure of acceptance criteria and reported performance for an AI/ML device, nor does it provide the detailed information requested in the prompt.

Based on the provided information, it is not possible to fully answer the request as it pertains to an AI/ML device. The document is a 510(k) summary for a medical device that uses negative pressure wound therapy, not an AI/ML-driven diagnostic or prognostic tool. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "how ground truth for training set was established" are not applicable in this context.

However, I can extract the information that is present concerning the device's performance testing for the non-AI device.

1. 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)

• Test set sample size: Not specified. The test involved a "simulated wound bed."
• Data provenance: Not specified, but likely laboratory testing. This was a non-clinical test.

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)

• Number of experts: Not applicable. This was a physical performance test of a mechanical device.
• Qualifications of experts: Not applicable.

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

• Not applicable. This was a physical performance test, not one requiring expert human judgment or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI device. The document mentions usability testing with clinicians and patients for instructional materials, but this is not an MRMC study comparing AI performance.

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

• Not applicable. This is not an AI algorithm. The pressure manifold test is inherently a "standalone" test of the device's physical performance, but not in the context of AI.

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

• The ground truth was based on the physical measurement of negative pressure distribution on a simulated wound bed. This is a functional performance metric, not a clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no training set for an algorithm.

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

• Not applicable. There is no training set for an AI algorithm.

Ask a specific question about this device

The Prevena 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.

Negative pressure wound therapy system for application to surgically closed incisions.

This K133232 510(k) summary describes the Prevena Incision Management System, a negative pressure wound therapy device.

Here's an analysis of the provided text regarding acceptance criteria and studies:

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

The provided document does not contain explicit acceptance criteria or a direct table comparing them to reported device performance. This 510(k) is a submission for a labeling change for an existing device, and it relies on substantial equivalence to previously cleared predicate devices (K123878 and K100821). The submission states: "There have been no technological changes to the predicate device for the purpose of the proposed labeling change."

Instead of performance criteria, the document asserts:

• "The Prevena Incision Management System and its predicate are substantially equivalent in terms of safety, function and indications for use."
• "The safety and effectiveness of the Prevena Incision Management System is adequately supported by the substantial equivalent information and data provided in this Premarket Notification."

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

• Sample Size for Test Set: Not applicable. No new clinical or non-clinical tests were performed for this particular 510(k) submission.
• Data Provenance: The document states that KCI conducted a systematic literature review of studies involving the Prevena Incision Management System and is adding a bibliography of published studies to the labeling. This suggests the data provenance is from retrospective, published clinical studies potentially from various countries, but specific details on the countries of origin are not provided in this summary.

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

• Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was created for this submission. The systematic literature review might have reviewed studies where expert consensus was used, but this is not detailed in the provided text.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No new test set required adjudication for this submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device in question is a medical device (Negative Pressure Wound Therapy System), not an AI diagnostic tool that would involve human readers and AI assistance.

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

• Standalone Performance Study: No. This is not an AI algorithm. It's a medical device that provides negative pressure wound therapy.

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

• Type of Ground Truth: For the systematic literature review, the "ground truth" would implicitly refer to the outcomes reported in the published clinical studies. These outcomes would likely include measures relevant to wound healing, infection rates, drainage management, and patient safety, which are typically derived from clinical observation, patient records, and potentially pathology reports depending on the specific study designs. The document states the system "is intended to manage the environment of surgical incisions that continue to drain... by maintaining a closed environment and removing exudate," implying ground truth would relate to these aspects.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document pertains to a resubmission for a labeling change for an existing medical device, not a new device requiring a training set or an AI algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable.

Ask a specific question about this device

The Prevena 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.

Negative pressure wound therapy system for application to surgically closed incisions.

The provided document is a 510(k) Summary for the Prevena Incision Management System with Customizable Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance, sample sizes for test and training sets, expert ground truthing, and MRMC studies is not present in this document.

However, based on the information provided, here's what can be extracted and what cannot:

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

Study Proving Acceptance Criteria:

The document states: "The Prevena Incision Management System with Customizable Dressing was evaluated under a number of design verification and validation tests to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device."

Specifically, the following tests were conducted:

• Biocompatibility testing according to ISO 10993-1.
• Equivalency testing with respect to delivery of negative pressure wound therapy.

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 for test set: Not specified. The document only mentions "design verification and validation tests" and "non-clinical tests."
• Data provenance: Not specified. As these were non-clinical tests, the concept of "country of origin" for patient data isn't directly applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. The tests mentioned are non-clinical (biocompatibility and functional equivalency) and do not involve human interpretation or ground truthing by medical experts in the way an AI diagnostic device would.

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

• Not applicable. The tests mentioned are non-clinical and do not require expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "No clinical tests were necessary." This device is not an AI diagnostic tool that would typically involve MRMC studies.

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

• Not applicable. This is a medical device (negative pressure wound therapy system), not an algorithm or AI. The "performance" refers to its mechanical and biological functionality, not an analytical algorithm's output.

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

• For biocompatibility: Ground truth would be established by validated laboratory assays and compliance with ISO 10993-1 standards.
• For equivalency in negative pressure delivery: Ground truth would be established by engineering specifications and direct measurement/comparison to the predicate device's performance.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set.

Ask a specific question about this device

The Prevena 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.

Negative pressure wound therapy system for application to surgically closed incisions.

The provided text describes a 510(k) submission for the "Prevena Incision Management System with Customizable Dressing." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria in the typical sense of a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance is not present in this regulatory document.

However, based on the provided text, I can extract and infer some information regarding the "acceptance criteria" (understood here as the demonstration of substantial equivalence) and the studies conducted to support it.

1. Table of "Acceptance Criteria" and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally framed around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The key "performance" here is equivalence to the predicate.

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

The document does not explicitly state the sample sizes for any test sets used in the biocompatibility, equivalency, or software verification and validation tests. The term "test set" as typically used in AI/Machine Learning evaluation (i.e., a dataset of cases used to evaluate an algorithm's performance) is not applicable here as this is a medical device regulatory submission focused on mechanical and functional equivalence, not an AI product.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the studies are likely laboratory-based and engineering verification/validation tests, not clinical studies with patient data in the typical sense.

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

This information is not applicable to the type of studies described. The "ground truth" for these tests would be established by engineering specifications, validated measurement techniques, and regulatory standards (e.g., ISO 10993-1) rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI datasets where expert opinions might differ. The studies mentioned (biocompatibility, equivalency testing, software V&V) are engineering and laboratory-based.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned. This device is not an AI-assisted diagnostic or prognostic tool for human readers; it is a negative pressure wound therapy system.

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

This question is not applicable. The device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this context refers to the established standards or predicate device performance against which the new device is compared.

• Engineering Specifications: For functional performance (e.g., negative pressure delivery).
• Regulatory Standards: For biocompatibility (ISO 10993-1).
• Predicate Device Performance: For demonstrating equivalence in indicated wound types, functional components, and therapy unit operation.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

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

Ask a specific question about this device

The ABThera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this system is in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

The therapy system consists of a therapy unit which delivers negative pressure through a tubing set to the dressing which is placed into the open abdomen. Controls within the therapy unit monitor delivery of negative pressure and provide safety alarms. The dressing manifolds negative pressure from the therapy unit and protects abdominal contents. A canister collects wound fluids removed under negative pressure.

The document describes the ABThera Open Abdomen Negative Pressure Therapy System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text only mentions "laboratory tests" for functional equivalence. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document. The device in question is a medical therapy system (Negative Pressure Wound Therapy System), not an AI/imaging diagnostic device that would require expert consensus for ground truth. The evaluation focused on the physical performance of the system against predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

A MRMC comparative effectiveness study was not done as this is not an AI/imaging diagnostic device intended to be used by human readers for interpretation.

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

A standalone study in the context of AI algorithms was not done. The "standalone" performance here would refer to the device's ability to maintain negative pressure and remove fluid, which was evaluated in laboratory tests without direct human intervention in the continuous therapy delivery, but the evaluation itself was conducted by human operators.

7. Type of Ground Truth Used

The ground truth used for the functional equivalence tests was the performance of legally marketed predicate devices. The new device's performance (negative pressure delivery and fluid removal) was compared against these established devices in laboratory settings to demonstrate equivalence.

8. Sample Size for the Training Set

This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as this device does not involve a "training set."

Ask a specific question about this device

The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

A dressing component of a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions

The V.A.C. VeraFlo Cleanse Dressing System is a dressing component of a negative pressure wound therapy (NPWT) system with an instillation feature. The device allows for controlled delivery and drainage of topical wound treatment solutions and suspensions.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria or specific performance metrics with target values. Instead, it describes various tests conducted to assure "conformance to design specifications" and concludes that the device "was shown to meet all performance requirements."

However, we can infer the general performance aspects evaluated:

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

• Sample Size: The document does not specify the exact sample sizes for each test. For the "acute swine model," it implies at least one swine was used, but the specific number is not provided. Bench tests typically involve multiple units or repetitions but the number is not stated.
• Data Provenance: The studies are described as "design verification and validation tests." They appear to be prospective studies conducted by the manufacturer (KCI, Inc.) for regulatory submission. The country of origin of the data is not explicitly stated, but given the manufacturer's address in San Antonio, Texas, USA, and the FDA submission, it is highly likely the studies were conducted in the USA.

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

This information is not provided in the document. The studies listed are primarily technical performance tests and an animal model study, which typically do not involve human expert consensus for "ground truth" in the same way clinical diagnostic AI studies might. For the swine model, the assessment of "granulation tissue formation and wound fill response" would be made by veterinary or medical researchers with expertise in wound healing, but their specific number or qualifications are not detailed. Biocompatibility testing follows established ISO standards, where the "ground truth" is defined by the test itself.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the studies are engineering/animal performance tests rather than clinical studies requiring adjudication of human readings or diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a medical device (dressing system), not a diagnostic AI or imaging interpretation algorithm designed to assist human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

This question is not directly applicable to the device. The V.A.C. VeraFlo Cleanse Dressing System is a physical dressing component of a Negative Pressure Wound Therapy system, not an algorithm. The software mentioned provides "controls for both negative pressure wound therapy and delivery of instillation therapy" and "controls for help and alarm functions," but it's an embedded control system, not a standalone diagnostic or interpretative algorithm. The performance evaluation focuses on the physical and biological interaction of the dressing system with the wound, not on standalone algorithm performance.

7. The Type of Ground Truth Used

The ground truth for the various tests can be described as follows:

• Functional Performance (Pressure, Fluid Distribution, Mechanical Properties): The ground truth is defined by engineering specifications and established physical principles. For example, pressure distribution would be compared against a desired range, and mechanical properties against industry standards (ASTM).
• Granulation Tissue Formation and Wound Fill Response: The ground truth is established through histological analysis, gross observation, and quantitative measurements in the animal model, interpreted by domain experts (e.g., veterinary pathologists, wound care researchers). This is akin to pathology findings and observational outcomes data in a controlled model.
• Biocompatibility: The ground truth is defined by international standards (ISO 10993-1), where passing specific cytotoxicity, irritation, and sensitization tests according to the defined protocols constitutes meeting the ground truth for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The V.A.C. VeraFlo Cleanse Dressing System is a physical medical device. It does not utilize machine learning or AI algorithms in a way that requires a "training set" for model development. The software mentioned provides control functions, which are typically developed through traditional software engineering and testing, not AI model training.

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

This information is not applicable/not provided as there is no "training set" for this type of medical device.

Ask a specific question about this device

The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. Therapy System which is an integrated negative pressure wound management system. The dressing is polyurethane foam with a silver coating designed specifically for use with the V.A.C. family of negative pressure wound therapy devices.

The provided documentation describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to a predicate device (K053627). The information primarily focuses on demonstrating equivalence rather than establishing acceptance criteria and performance against novel targets.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of quantitative performance metrics for a new study. Instead, it demonstrates that the new device has "Same as predicate" or "equivalent results" for certain characteristics.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for the antibacterial activity testing. The document mentions "Studies of the antibacterial activity of the predicate device were previously conducted" and then states "testing has been conducted" for the proposed change. It does not provide the sample size of the new testing.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the nature of the tests (antibacterial activity) suggests laboratory-based testing rather than patient data.

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

   • Not applicable. The "ground truth" here relates to the results of antibacterial activity in a laboratory setting, not clinical expert assessment.

3. Adjudication method for the test set:

   • Not applicable, as the evaluation is based on laboratory test results, not expert review or adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a medical device (dressing) submission, not an AI software or imaging study.

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

   • No. This is a physical medical device.

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

   • For antibacterial activity, the ground truth is likely defined by standardized microbiological testing protocols and quantitative measurements of bacterial reduction or inhibition, as compared to the established performance of the predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable.

Ask a specific question about this device