(135 days)
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:
- Protruding discs
- Bulging discs
- Herniated discs
- Degenerative disc disease
- Posterior facet syndrome
- Acute facet problems
- Radicular pain
- Prolapsed discs
- Spinal root impingement
- Hypomobility
- Degenerative joint disease
- Facet syndrome
- Compressions fractures
- Joint pain
- Discogenic pain
The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.
The provided text is a 510(k) Summary Statement for the Mettler Traction Device, MTD 4000. It details the device's description, intended use, and a comparison to predicate devices for substantial equivalence.
However, the document does not contain information about specific acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets such criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance, a common requirement for new or higher-risk devices.
Therefore, I cannot fulfill your request for the following information based solely on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technological characteristics to predicate devices.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described.
- 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): No ground truth establishment or expert involvement in a study is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication is mentioned.
- 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: This device is a physical traction device and does not involve AI or human readers in the context of diagnostic interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in relation to performance criteria.
- The sample size for the training set: Not applicable as it's not an AI/ML device that requires training.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is a comparison table of the MTD 4000 with predicate devices, highlighting similar features and differences in physical characteristics and user interface configurations. This comparison serves to demonstrate substantial equivalence, rather than meeting specific performance acceptance criteria from a study.
The FDA's letter (Page 3-4) states that they "have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This confirms the nature of the submission and review process.
§ 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).