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The V.A.C.® family of devices with woundsite feedback control are negative pressure devices used to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.

All models of the VAC family of devices, including the V.A.C.® ATS™, mini V.A.C.®, and the V.A.C.® Freedom™, consist of a vacuum control unit with an integrated collection canister and power supply.

The provided 510(k) summary for the V.A.C.® Therapy family of devices does not include information about specific acceptance criteria or an analytical study with performance metrics in the way a typical AI/ML device submission would.

This particular 510(k) is for a medical device (powered suction pump) that was reviewed for substantial equivalence to existing predicate devices based on its design, intended use, and functional testing. The "study" referenced is primarily design verification and validation testing, not a clinical trial or performance study with quantified metrics and statistical analysis against ground truth.

Therefore, many of the requested categories cannot be directly extracted from the provided text. However, I will answer the questions based on the information that is present and explain where information is not available.

Response based on the provided text:

Acceptance Criteria and Device Performance Study (V.A.C® Therapy family of devices)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document describes a "510(k) Summary" for a conventional medical device (Powered Suction Pump). The acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through design verification and validation testing (including functional and electrical safety), rather than through a comparative performance study with specific quantifiable metrics like sensitivity/specificity for diagnosis or a precise treatment outcome measure.

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 applicable or not specified in relation to patient data. The "testing" mentioned refers to internal device verification and validation (functional and electrical tests), not a clinical trial on a patient cohort.
• Data Provenance (country of origin, retrospective/prospective): Not applicable, as this was not a study involving patient data.

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

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, was not established for a test set in this 510(k) submission. The "ground truth" for this device's performance would be its ability to consistently apply controlled negative pressure and function safely, which is assessed through engineering and functional tests.

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

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication of findings.

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 Comparative Effectiveness Study: No, an MRMC study was not done. This device is not an AI/ML diagnostic or therapeutic assistance tool for human readers/clinicians, but rather a direct treatment device.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical medical device (powered suction pump), not an algorithm or software. It functions with human setup and monitoring, applying negative pressure directly to a wound.

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

• Type of Ground Truth: For the device's functional performance, the ground truth would be adherence to engineering specifications and safety standards for powered suction pumps (e.g., maintaining specified negative pressure levels, electrical safety standards). For "intended use," the predicate devices' established safety and effectiveness serve as the comparative ground truth. No patient-level ground truth (like pathology or clinical outcomes) was utilized for a performance study described here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an AI/ML algorithm.

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The V.A.C. Abdominal Dressing is a specialty dressing 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 dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

The V.A.C. Abdominal Dressing will be provided in a kit to provide an easy, tailored method of applying the dressing in the open abdomen. The V.A.C. Abdominal Dressing is supplied sterile, for single use only, double-pouched and packaged as one kit.

Each V.A.C. Abdominal Dressing kit contains:

• One (1) internal contact laver .
• Two (2) 16 mm outer layer polyurethane open-cell foam pieces .
• Four (4) V.A.C. Drapes .
• One T.R.A.C.TM pad assembly .

The provided text is a 510(k) summary for the V.A.C.® Abdominal Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific performance metrics and acceptance criteria as would be found for a new diagnostic or AI-driven medical device. Therefore, the information requested in the prompt, such as acceptance criteria, reported performance, sample sizes, expert qualifications, and ground truth establishment, is not available in this document.

The document states:

"Substantial equivalence for the V.A.C. Abdominal Dressing is based on the indications, intended use and technological features."

And also, regarding biocompatibility:

"Material Biocompatibility issues have been addressed based upon biomaterial history. The material used in the KCI V.A.C. Abdominal Dressing are the same materials used for many years in the existing commercially available devices."

This indicates that the device's acceptance was based on its similarity to previously cleared devices in terms of materials, indications, and function, not on a new study demonstrating quantitative performance metrics against specific acceptance criteria.

Thus, I cannot populate the table or answer the specific questions about study details, as these types of studies were not conducted or reported for this 510(k) submission.

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The V.A.C. Instillamat device 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. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts Inc. The V.A.C. Instillamat device combines technologies and features of the V.A.C. Plus device previously cleared by the FDA in 1999 [510(k) No. K992448] and the Ambulatory V.A.C. device previously cleared by the FDA in 1997 [510(k) No. K971548] with the additional modifications to provide a controlled delivery system for applying secondary wound treatments to a wound.

This document is a 510(k) summary for the V.A.C. Instillamat device, which is a medical device for wound care. It discusses the device's classification, applicant information, description, indications for use, and substantial equivalence.

Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria in the way you've outlined for an AI/device performance study.

Here's why and what information is available:

• This is a 510(k) submission for substantial equivalence. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically involve detailed performance studies with acceptance criteria in the manner of a novel AI algorithm.
• The "study" referenced is compliance with safety standards. The document states: "The V.A.C. Instillamat device has essentially the same technologies and features as the previously cleared predicate devices and has been independently tested and successfully approved to the following medical safety standards: UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4." This demonstrates electrical safety, electromagnetic compatibility, and general safety requirements for medical electrical systems, not clinical performance for wound healing or specific diagnostic accuracy.

Therefore, many of your requested points cannot be answered from this document.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

   • Acceptance Criteria: The implicit acceptance criterion is adherence to the listed safety standards (UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4) and being "substantially equivalent" to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) in terms of technology, features, and indications for use.
   • Reported Device Performance: The document states the device was "independently tested and successfully approved to" these standards. No specific performance metrics like accuracy, sensitivity, or specificity (common for AI algorithms) are provided because this is not that type of study.

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 as no clinical performance study on a "test set" is described for this 510(k). The "testing" refers to compliance with engineering and electrical safety standards.

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. Ground truth establishment for a test set is not mentioned.

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

   • Not 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:

   • Not applicable. This device is a powered suction pump for wound care, not an AI diagnostic or assistance tool for human readers.

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

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

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

   • Not applicable in the context of clinical performance. For the safety standards, the "ground truth" is typically defined by the requirements of those standards (e.g., specific voltage limits, leakage current limits, EMC emission/immunity limits), and the device's electrical and mechanical performance is measured against these.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device.

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

   • Not applicable.

In summary: The V.A.C. Instillamat device gained clearance (K021501) through a 510(k) pathway by demonstrating substantial equivalence to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) and by successfully complying with relevant medical electrical safety and electromagnetic compatibility standards (UL2601-1, IEC 60601 series). This process does not involve clinical performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be seen for a diagnostic or AI-powered device.

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