(214 days)
The Verseo Air Pressure Massager is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas. The Verseo Air Pressure Massager simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
The Verseo Air Pressure Leg Massager is an inflatable cuff that wraps around the lower leg and is secured by a Velcro strap, operated via AA battery-powered electronic touch-pad controller with colored LED's denoting pressure increase, decrease and automatic massage function.
The provided text describes a 510(k) submission for the "Verseo Air Pressure Leg Massager," a Class II powered inflatable tube massager. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with acceptance criteria and performance data in the typical sense for a diagnostic or treatment efficacy device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there is no explicit table of acceptance criteria or reported device performance for a clinical study. The submission emphasizes compliance with performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act, and the fact that "All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks." This refers to safety and electrical standards, not the clinical effectiveness or performance in terms of patient outcomes.
The "Indications for Use" section states: "The Verseo Air Pressure Massager is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas." The acceptance criteria would presumably relate to achieving these temporary effects, but no clinical study demonstrating these effects with specific metrics is detailed.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Does the submission include clinical information? NO." Therefore, there is no test set, sample size, or data provenance related to a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since no clinical study was conducted or presented, no experts were used to establish ground truth for a test set. The device's safety and effectiveness are supported by its substantial equivalence to predicate devices and adherence to general electrical/safety standards.
4. Adjudication Method:
As no clinical study or test set is described, there is no information on an adjudication method.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The device is a massager, not a diagnostic tool where reader performance would be a primary concern. The submission focuses on device safety and equivalence.
6. Standalone Performance Study:
No standalone performance study (algorithm only performance, without human-in-the-loop) was conducted or presented. This device is a physical massager and does not involve an algorithm in the sense of AI or image analysis.
7. Type of Ground Truth Used:
Since no clinical study was performed, there is no mention of ground truth established through expert consensus, pathology, or outcomes data for the purpose of evaluating the device's stated indications for use (relief of minor muscle aches and pains, increased circulation). The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices.
8. Sample Size for the Training Set:
No training set is mentioned or applicable as no clinical performance study or AI algorithm development is described.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used.
Summary of Device Acceptance and Study Limitations based on the K092435 Submission:
This 510(k) submission for the Verseo Air Pressure Leg Massager relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. The pathway for approval here does not mandate the conduct of a new clinical study to prove the device's efficacy in relieving minor muscle aches and pains or increasing circulation.
Instead, the acceptance criteria are implicitly met by:
- Compliance with performance standards: "These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act." This likely refers to electrical safety and mechanical integrity standards.
- OSHA/NRTL listing and constituent marks: Indicating adherence to recognized safety standards for electrical and radiological products.
- Demonstrated safety and effectiveness of predicate devices: The core argument for substantial equivalence is that if the predicate devices are safe and effective for the stated indications, and the new device is substantially similar in technology and intended use, then it too can be considered safe and effective.
The submission explicitly states that no clinical information (i.e., a clinical study with detailed performance data) was included. Therefore, the questions regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods for a clinical study are not addressed by this document.
§ 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).