(51 days)
The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
The Back-tek device is a far infrared heating device that is provided in a back support belt.
The provided text describes the 510(k) summary for the Back-Tek device, an infrared lamp, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria related to its performance beyond general therapeutic heat.
Here's a breakdown of what is and is not in the provided text, aligning with your requested information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The only performance data mentioned is "Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle."
- Reported Device Performance: The text states the device "provides therapeutic heat during the treatment cycle." It does not provide specific temperature ranges, rise times, or other quantifiable performance metrics that would typically be part of an acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not found. The document mentions "Skin temperature testing" but provides no details on the sample size used, whether the study was retrospective or prospective, or the country of origin of the data.
3. 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 applicable / Not found. This type of information is typically relevant for diagnostic devices where expert review establishes a "ground truth" for classification tasks. The Back-Tek is a therapeutic device (infrared lamp) for pain relief and circulation. The "performance data" mentioned is purely related to physical parameters (temperature), not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not found. Similar to point 3, adjudication methods are used in studies involving expert review for diagnostic agreement. This is not relevant for a device like the Back-Tek.
5. 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 / Not found. This device is an infrared lamp, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not found. The Back-Tek is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not found. For the "Skin temperature testing," the "ground truth" would be the actual temperature measurements, which are objective physical parameters, not a subjective interpretation requiring expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
- Not applicable / Not found. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not found. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
Summary of available information:
The provided documents focus on the regulatory classification (510(k) submission) of the Back-Tek device as an infrared lamp. Its "Performance Data" section merely states that "Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle." This is a general statement of functionality rather than a detailed report of a study with specific acceptance criteria, methodology, or results. The primary argument for clearance is substantial equivalence to a predicate device (Thermotex Platinum Heat Therapy System cleared in K092589) based on "indication for use and technological characteristics," implying that if the predicate device met safety and effectiveness standards, the similar Back-Tek device should as well.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.