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The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers NIR Module is an additional module to the existing Alma Lasers, I.td. (former MSq.) Soprano Diode Laser System cleared under K052874.

The Alma Lasers NIR Module is comprised of the following components:

• An 'umbilical' cable and connector, that is permanently attached to the NIR module body and semi-permanently attached to the laser system that houses:
• Electrical cables (to support the thermoelectric coolers (TFC) associated with the chilled sapphire window, to provide power to the pulsed light source (quartz tube), and to connect to a memory device that identifies the module)
• A supply and return water line (to remove the heat generated by the infrared lamp and thermoelectric cooler)
• Module body (shells) housing the module internals and connecting to the umbilical.

The light source emits a pulse when it is activated by pressing the footswitch. The light passes through an aperture with a filter, into a lightguide that is located on the module tip. The operator holds the handpiece by its handle in order to position the lightguide against the patient's skin.

The module tip is TEC-cooled to provide contact skin cooling. The module contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the LCD control panel. The temperature at the skin surface does not exceed 40°C.

The NIR module is operated only by pressing the footswitch.

The proximal end of the umbilical is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the NIR delivery module. The Alma Lasers NIR Module is removable by either the user or an authorized filed service engineer for replacement at the proximal end.

This document (K080318) is a 510(k) summary for the Alma Lasers NIR Module, which is an additional module for the existing Alma Lasers Soprano Diode Laser System. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance criteria against pre-defined acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted because such a study is not part of this 510(k) submission. The FDA clearance for this device is based on substantial equivalence to existing legally marketed devices, not on the presentation of new clinical trial data demonstrating performance against specific numerical endpoints.

Here's a breakdown of why each requested point cannot be addressed from the provided text:

1. Table of acceptance criteria and reported device performance: Not provided. The submission states the device shares the same indications for use, operation, technical and functional capabilities with predicate devices, implying similar performance, but it doesn't quantify specific performance metrics or acceptance criteria for those metrics.
2. Sample size used for the test set and data provenance: No test set or associated data is described as part of a performance study in this document.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable, as no such study is described.
4. Adjudication method for the test set: Not applicable, as no such study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or described in this submission.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a laser module for therapeutic heating, not an AI or algorithm-driven diagnostic device.
7. Type of ground truth used: Not applicable, as no performance study with ground truth establishment is described.
8. Sample size for the training set: Not applicable, as this is a hardware device where "training sets" in the context of AI/algorithm development are not relevant.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Conclusion based on the provided document:

The Alma Lasers NIR Module obtained 510(k) clearance (K080318) on March 7, 2008, by demonstrating substantial equivalence to predicate devices (Palomar LuxIR Handpiece, Cutera Titan Tabletop Product, Altus Medical Optional Infrared Handpiece). The basis for this equivalence is that the device shares the same indications for use, the operation, technical and functional capabilities with these predicate devices.

The indications for use are: "The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain."

No specific clinical studies with defined acceptance criteria for device performance were presented or required for this 510(k) submission, as it relied on the established safety and effectiveness of the predicate devices.

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