(198 days)
The subject device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the device may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
QK Therapeutic Apparatus, including 7 different models, consists of Energy generator, Height adjustment knob, Support, and Control box. It is used to provide topical heating to the body by the energy generator. The energy generator is composed of many semiconductor ceramic piece, and it can emit multiple peak wide-band nanometer waves which can be absorbed by human.
The device C01A, C01B, C01CZ, C01EZ and QK-S14 are desktop style, while the other models are Floor Standing. The Emission spectrum ranges from 6K to 12K nm, the Energy Peak Value Wave Range is 9300nm±465nm and the All-direction Eradiation Rate is at least 83 %, The energy generator shall be replaced after 15000 hours of usage.
This document is a 510(k) premarket notification for a medical device called "QK Therapeutic Apparatus." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria. Therefore, much of the requested information regarding a device performance study is not available in this document.
Here's the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in the context of a clinical performance study. Instead, it compares the subject device's technical specifications and intended use against a predicate device to demonstrate substantial equivalence. The "performance" reported primarily relates to physical and electrical characteristics and adherence to safety standards.
| Characteristic / Acceptance Criteria (Implied for Substantial Equivalence Comparison) | Reported Device Performance (QK Therapeutic Apparatus) |
|---|---|
| Indications for Use | Temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, relaxation of muscles. May also help muscle spasms, minor sprains & strains, and minor muscular back pain. |
| Operation Principle | Energy generator emits infrared wave to provide topical heating for the purpose of temporary pain relief of muscular pain, arthritis, shoulder pain, back pain and joint stiffness. |
| Spectrum Ranges | 6K~12Knm |
| Peak Wave Length | 9300±465nm |
| Length of Generator | 18.5~35.5cm |
| Lifetime of Generator | 15000h |
| Control Timer | No or Yes |
| Power Supply | AC120V |
| Power | 160~230W |
| Power Frequency | 50~60Hz |
| Warm-Up Time | 3 min |
| Irradiation Distance | 20-30cm |
| Irradiation Time | High: 20-40min/turn, Low: 30-60min/turn |
| Maintain Time | 15-20min |
| Skin Temperature | 40-45°C |
| Style | Desktop & Floor standing |
| Operating Environment | Temperature: 5℃~40℃, Humidity: ≤85%RH |
| Storage Environment | Temperature: -40°C ~55°C, Humidity : ≤85%RH |
| Conformance Standard | IEC60601-1 (Safety), IEC60601-1-2 (EMC) |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable. The document does not describe a clinical performance study with a test set of patient data. The "performance data" refers to compliance with electrical safety and EMC standards and "performance test result in section 11 of this submission" (which is not included in the provided text, but likely refers to technical specifications rather than patient outcomes).
- Data provenance: Not applicable for a clinical test set. The technical specifications and compliance data would originate from the manufacturer's internal testing and laboratories. The country of origin of the device manufacturer is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth or expert-reviewed test set is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process is described.
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. This device is an infrared therapeutic apparatus, not an AI-assisted diagnostic or interpretative device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. Its performance is demonstrated through technical specifications and compliance with safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical performance study. The "ground truth" for demonstrating substantial equivalence relies on comparing the device's technical specifications and safety/EMC compliance to a legally marketed predicate device and recognized standards (IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set:
- Not applicable. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of 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.