(293 days)
The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sport injuries
- Post immobilization edema
- Venous insufficiencies
- · Lymphedema.
The TSTI biotouch™ device is a microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest. The device consists of two major components:
- lightweight, portable pneumatic controller, and .
- extremity garments composed of 4 to 16 chambers. .
The controller is pre-programmed with thirteen separate treatment programs. which consists of pre-determined sequences and inflation times and should be used under medical supervision. The device is provided to the end-user in individual cartons to ensure safe shipping and arrival of the device.
This document is a 510(k) summary for the biotouch™ Massage Therapy System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states "Performance testing was completed to verify the design specifications necessary for the biotouch™ device. Test results support the safety and performance of the biotouch™ device for its intended use," but no specific criteria or results are detailed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
- 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 provided. This type of device (a pneumatic compression system) typically doesn't involve "ground truth" derived from expert image interpretation in the same way an AI-driven diagnostic tool would.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 is a physical therapy device, not an AI-driven diagnostic or image analysis tool. There are no "readers" in the context of an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, and likely not applicable in the way it would be for a diagnostic algorithm. Performance for such a device would typically relate to pressure accuracy, cycle timing, durability, and safety, not diagnostic ground truth.
- The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document is a 510(k) submission summary for a physical medical device. It indicates that performance testing was completed and supports the safety and performance, but it does not provide any specific acceptance criteria, performance metrics, or details about the studies conducted. The submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, materials, and construction, rather than presenting detailed performance study results against specific criteria.
§ 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).