(88 days)
The Energex is indicated for use for the temporary relief of chronic temporomandibular joint (TMJ) pain.
The Energex is a therapeutic medical device that delivers pulsed radio-frequency energy to tissue as indicated for the relief of chronic TMJ pain.
The provided text is a 510(k) summary for the Orthosonix Energex device, which is indicated for the temporary relief of chronic temporomandibular joint (TMJ) pain. However, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study design (e.g., MRMC, standalone). The document states that "equivalence was shown through bench, animal and clinical data submitted in the 510(k)," but it does not provide a summary of these data or the specific acceptance criteria met.
Therefore, I cannot fully answer your request based on the provided text. I will indicate where the information is missing.
Here's an attempt to answer the questions based only on the provided text, with explicit notes about missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific acceptance criteria are not mentioned in the provided text. | The device was found to be "substantially equivalent to shortwave diathermy devices that are also indicated for the relief of joint pain." The text states this equivalence was shown through "bench, animal and clinical data submitted in the 510(k)," but does not provide specific performance metrics or how they meet unstated acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text. The text only generically states "clinical data submitted in the 510(k)."
- Retrospective or Prospective: Not mentioned in the provided text.
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 mentioned in the provided text. The document refers to "clinical data" but does not detail how ground truth for any test set was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned in the provided text.
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 mentioned in the provided text. The device description suggests a therapeutic device, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant here.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- The device is described as a "therapeutic medical device that delivers pulsed radio-frequency energy to tissue." Its performance would inherently be in a "standalone" or direct therapeutic context on a patient, not as an algorithm interpreting data. The text does not provide performance results for this standalone therapeutic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the provided text. For a therapeutic device for pain relief, the ground truth for clinical studies would typically involve patient-reported outcomes (e.g., pain scales, quality of life measures), which would be a form of "outcomes data." However, the document does not specify this.
8. The sample size for the training set
- Not mentioned in the provided text.
9. How the ground truth for the training set was established
- Not mentioned in the provided text. If the "training set" refers to data used to establish device parameters or effectiveness, the method for establishing ground truth for those studies is not detailed.
§ 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.