(269 days)
The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.
The device is a powered traction device pursuant to 21 CFR 890.5900 (FDA product code ITH) class 2. The device is substantially equivalent to various other traction devices which achieve their effect through the force of gravity and/or mechanical means.
Acceptance Criteria and Device Performance for GraviLax Traction System
The provided document (K072064 for the GraviLax Traction System) does not contain any information regarding acceptance criteria, device performance studies, or any of the detailed questions about clinical trial design (sample size, ground truth, expert qualifications, etc.).
The document is a 510(k) summary and the FDA's clearance letter, which focuses on establishing substantial equivalence to existing legally marketed devices. It describes the device, its intended use, and lists predicate devices. However, it does not include performance data or studies designed to meet specific acceptance criteria.
Therefore, I cannot provide the requested information based on the input text.
Explanation:
- 510(k) Clearance: This type of submission (510(k)) generally aims to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparative technological characteristics, materials, and intended use, rather than extensive clinical efficacy trials with predefined acceptance criteria.
- Lack of Performance Data: The provided text is purely administrative. It defines the device, its classification, and the regulatory outcome (clearance). It doesn't present any study results, statistical analyses, or performance metrics.
- No Mention of Clinical Studies: There's no mention of a particular study, sample sizes, ground truth establishment, expert involvement, or any form of comparative effectiveness or standalone performance assessment.
To answer your questions, the original 510(k) submission document or supporting technical files would need to contain information about specific performance testing and its results, which are not present in this summary.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).