(153 days)
The Infrared Heating Device, Model PM-750, temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
The Infrared Heating Device, Model PM-750, is 110V AC powered, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared bulb. The device consists of a handle that houses the electronics and controls, and tungsten infrared bulb with light filter. The light filter is intended to be placed directly on the skin to provide topical heating. The infrared bulb is replaceable. The housing material is ABS.
The provided text is a 510(k) summary for an Infrared Heating Device, Model PM-750. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence, rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI/medical imaging device. As such, many of the requested elements (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study, AI improvement effect size) are not applicable to this type of submission.
However, I can extract information related to performance testing that served to confirm the device's safety and effectiveness in relation to its intended use and the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Parameter | Reported Device Performance (PM-750) |
|---|---|
| Therapeutic Temperature Range: 40-45°C | Achieves 40-45°C |
| Approximate Maximum Skin Temperature (Low Level): 40.5°C | 40.5°C |
| Approximate Maximum Skin Temperature (High Level): 44.5°C | 44.5°C |
| Time to reach therapeutic temperature (Low Level): 5-10 min | 5-10 minutes |
| Time to reach therapeutic temperature (High Level): 3-5 min | 3-5 minutes |
| Maintain temperature above 40°C: | Maintained temperature above 40°C for at least 10-15 minutes of a 30-minute cycle time. |
| Maximum temperature at sensor (skin): Not exceed 45°C | Never exceeded 45°C. |
| Safety Standards Compliance: | Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2. |
| Biocompatibility Standards Compliance: | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
2. Sample size used for the test set and the data provenance
- Sample Size for performance testing: 6 participants
- Data Provenance: The document doesn't specify the country of origin for the participants, nor whether the study was retrospective or prospective. It describes an in-house performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The performance testing involved objective temperature measurements on participants, not expert interpretation of data for ground truth establishment.
4. Adjudication method for the test set
- This is not applicable as the test involved objective measurements, not expert adjudication.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is an infrared heating device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone heating device; it does not involve algorithms or human-in-the-loop performance in the context of AI. The performance tests were conducted on the device operating independently.
7. The type of ground truth used
- The ground truth for the performance testing was objective physical measurements: digital temperature sensor readings on the skin of participants.
8. The sample size for the training set
- This is not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable, as this is not an AI/machine learning device that requires a training set.
§ 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.