(76 days)
The Altus Medical optional infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature 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 the relaxation of muscles. In addition, the Altus Medical optional infrared handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The optional infrared handpiece consists of:
- an "umbilical" cable and connector, that is permanently attached to the hand piece A body and is semi-permanently attached to the laser system (detachable by positive action from the user) that houses:
- electrical cables (to support the thermoelectric coolers associated with the chilled A sapphire window, to provide power and an electrical drive current to the IR quartz lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
- a supply and return water line (to remove the heat generated by the infrared lamp and A thermoelectric cooler);
- the hand piece internals described above; and A
- the hand piece shells housing the internals and connecting to the umbilical. A
The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
This optional infrared handpiece is for use specifically with the Altus Medical CoolCilide Xeo laser system previously cleared on K023954.
This 510(k) premarket notification describes the Altus Medical Optional Infrared Handpiece, which is intended to provide topical heating for temporary pain relief and muscle relaxation. The document asserts that the device is substantially equivalent to existing infrared heat lamps.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or quantitative performance metrics for the Altus Medical Optional Infrared Handpiece. Instead, it relies on a qualitative comparison to predicate devices, asserting "substantial equivalence" in technological characteristics and safety/effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific test data or studies involving human subjects or a test set. The submission is based on a comparison to existing predicate devices and an assertion that no new questions of safety or effectiveness are raised.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific test set or study is described, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no test set or study is described, there is no information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention any MRMC comparative effectiveness study. The submission focuses on device characteristics and equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is not an AI algorithm. It is a physical medical device (an infrared handpiece). Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this submission.
7. Type of Ground Truth Used
Given that no specific studies or test data are provided, there is no explicit ground truth (e.g., expert consensus, pathology, outcomes data) mentioned in relation to the Altus Medical Optional Infrared Handpiece's performance. The "ground truth" for the substantial equivalence claim appears to be the established safety and effectiveness of the identified predicate devices.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI algorithm, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, this question does not apply.
Summary of the Study and Acceptance Criteria:
The 510(k) submission for the Altus Medical Optional Infrared Handpiece relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a new clinical study with defined acceptance criteria and performance data.
The "acceptance criteria" here are implicitly that the device's technological characteristics, indications for use, and potential risks/benefits are comparable to those of the predicate devices. The study proving this is a qualitative comparison of technical specifications and intended use against the identified predicate devices:
- K001056 Olympic Warm-up by Olympic Medical
- K022609 PW820 Patient Warmer by Fisher & Paykel
- K023621 BioFlex Professional Therapy System by Meditech International
- K024179 Thermapulse by Palomar Medical Technologies, Inc.
The document asserts that the infrared handpiece shares "the same general indications for use" and relevant "technological characteristics" such as lamp type, timer, wattage, power, wavelength, protective enclosure, spot size, skin contact, cooling, and energy, with its predicate devices. Through this comparison, Altus Medical concludes that "there are no new questions of safety or effectiveness raised by the introduction of this device."
§ 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.