(74 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative performance metrics in the provided document. The submission focuses on substantial equivalence to predicate devices. | Functional Performance: The devices in the V.A.C. family were subjected to "functional performance testing" and "electrical leakage testing." |
| Equivalence to Predicates: The devices "do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness" compared to the V.A.C. Plus (K992448) and Ambulatory V.A.C. (K971548). | |
| Intended Use: The device performs as intended, which is to help promote wound healing through negative pressure, vacuum-assisted drainage, and removal of infectious material/fluids. | |
| Safety & Effectiveness: "raises no new safety or effectiveness issues." |
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.
§ 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.