(234 days)
The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-Temporary relief of minor joint pain associated with arthritis.
-The temporary increase in local circulation where applied.
-Relaxation of muscle.
The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
The given document is a 510(k) premarket notification for a medical device (N7-S Multi-Function Physical Therapy Table) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document primarily focuses on establishing substantial equivalence to predicate devices (CGM MB-1701 & CGM MB-1702, and N5-1) based on indications for use, technological characteristics, and performance testing for safety and basic functionality (e.g., temperature range, pressure performance of air cell massager).
The sections that might contain information about studies are "Performance Test" and "Clinical Test Summary" (page 14). However, these sections state:
- Performance Test: "A comprehensive performance test was conducted on the subject device, including a pressure performance test of the Air Cell Massager, to substantiate its equivalence to the predicate device A(K220572)." It lists items evaluated such as temperature range, extra overheating protection, temperature sensor function, heating part, skin surface temperature, and pressure performance of the Air cell massager. It concludes that "the subject device met all applicable performance requirements and was substantial equivalent with predicate devices."
- Clinical Test Summary: "No clinical studies are considered necessary and performed."
Therefore, the provided document does not describe: AI/ML acceptance criteria, a study proving an AI/ML device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or how ground truth for training data was established.
The device, N7-S, appears to be a physical therapy table with heat and massage functions, including an air massager. It is not an AI/ML-driven device based on the provided text, and thus, the detailed questions about AI/ML performance metrics are not applicable to this submission.
Without information on AI/ML components or their performance evaluations, I cannot fill out the requested table or provide details on the study's AI/ML specific aspects.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).