(33 days)
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patient always holds a safety switch that can interrupt treatment if it becomes uncomfortable. Several "mechanical waveforms" are available for selection by the operator, including: (1) Basic intermittent traction, (2) Incremental intermittent traction, (3) Incremental and decremental intermittent traction, (4) Residual intermittent traction, (5) Incremental and residual intermittent traction, (6) Incremental, decremental and residual intermittent traction, (7) Basic continuous traction, (8) Incremental continuous traction. The residual tractive force, the duration time setting, the pause time setting, the tow speed, and the treatment time setting are all programmable up to specified limits. For forces selected above 18 kg, the system always asks for confirmation of the selected value by the operator before proceeding. A limit switch prohibits output exceeding 100 kg.
The provided K992545 510(k) Summary for the TM-300 Traction System does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and compliance with electrical safety and electromagnetic compatibility standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., pain reduction, disc decompression) or diagnostic accuracy. The "acceptance criteria" discussed are related to safety and manufacturing standards, and "reported device performance" is primarily about compliance with these standards and the device's functional capabilities.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with EN-60601 standard | Certificate of compliance issued by TÜV |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2 standard | Attestation of Conformity issued by TÜV |
| Design Specifications | Met design specifications (implied functional requirements like force limits, timing, waveforms) | "The design qualification testing demonstrated that the TM-300 met its design specifications." |
| Premarket Notification Requirements | Met requirements for substantial equivalence and regulatory compliance | Demonstrated Substantial Equivalence as defined in the Federal Food Drug and Cosmetic Act and guidance documents. |
2. Sample Size Used for the Test Set and the Data Provenance
No sample size for a test set or information about data provenance (e.g., country of origin, retrospective/prospective) is mentioned for clinical effectiveness or diagnostic accuracy. The testing mentioned refers to engineering and safety performance tests, not clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The submission does not describe a test set requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The device is a therapeutic traction system, not a diagnostic imaging or interpretation tool where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. The TM-300 is a physical medical device (traction system) that interacts directly with the patient, not a software algorithm with standalone performance. Its operation involves an operator, and a safety switch held by the patient allows interruption.
7. The Type of Ground Truth Used
For the engineering and safety tests, the "ground truth" would be established by the specifications defined during the device's design and the relevant regulatory standards (EN-60601, EN 60601-1-2). For clinical efficacy, no ground truth data from studies are provided in this submission; instead, reliance is placed on the substantial equivalence to a predicate device that presumably established its efficacy.
8. The Sample Size for the Training Set
Not applicable. This device is a physical traction system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is described for this device.
Summary of the Study/Evidence Provided in the K992545 510(k) Summary:
The provided document describes a technical performance and safety validation study rather than a clinical efficacy study. The main focus of the testing was to demonstrate:
- Compliance with electrical safety standards: The device underwent testing to ensure it met the requirements of the EN-60601 standard, with a certificate of compliance issued by TÜV.
- Compliance with electromagnetic compatibility standards: The device was tested to meet the EN 60601-1-2 standard, with an Attestation of Conformity from TÜV.
- Adherence to design specifications: "Design qualification testing demonstrated that the TM-300 met its design specifications," implying that its functional outputs (e.g., force levels, timing, waveform generation) performed as intended.
The basis for the device's clinical indications (relief of low back pain associated with herniated discs, etc.) is its substantial equivalence to a previously cleared predicate device (DRS System, K981822), rather than independent clinical trials conducted for the TM-300 itself. The submission asserts that the TM-300 has the "same indications for use and target population as the legally marketed predicate devices" and "the same technological characteristics." Therefore, the "study" proving the device meets clinical acceptance criteria is essentially the prior clearance and presumed efficacy of the predicate device.
§ 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).