(96 days)
The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health.
The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.
The provided document describes the NormaTec MVP, a powered inflatable tube massager. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance evaluations with specific metrics.
Instead, the document focuses on:
- Substantial Equivalence: The primary method for FDA clearance (510(k)) is by demonstrating that a new device is as safe and effective as a legally marketed predicate device.
- Safety Testing: The document mentions "safety testing and quality assurance testing" were performed, stating that "In all instances, the NormaTec MVP functioned as intended and the results observed were as expected." It also notes compliance with electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). This is a general statement about manufacturing and basic functional checks, not a clinical performance study against specific acceptance criteria for efficacy.
- Intended Use & Technological Characteristics: Details about what the device does and how it works.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the requested information is not present in the provided text.
Based on the available text, here's what can be inferred or directly stated:
Information from the Document:
- Table of Acceptance Criteria and Reported Device Performance: Not applicable. The document does not specify quantitative acceptance criteria or a performance study with measurable outcomes beyond general safety and functionality.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance (country, retrospective/prospective) is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described for a performance study.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document states: "Performance data demonstrate that the MVP is as safe and effective as the predicate device." This general statement refers to the substantial equivalence argument based on similar design, intended use, and functioning as predicate devices, not a new clinical performance study with defined acceptance criteria and statistical outcomes.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).