(207 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
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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.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.