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The Cutera Titan Tabletop Product with an 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 Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Cutera Titan Tabletop Product consists of a modified console designed to drive the infrared handpiece, which is an existing, FDA cleared attachment for the existing, FDA cleared laser. The handpiece is an infrared handpiece with a variable emission of 0.8 to 2.0 microns (850 - 3000 nm). The delivered wavelength is filtered to 1100nm - 1800nm via coated glass filters to eliminate the extraneous wavelengths.

The Cutera Titan Tabletop Product is comprised of five main components:

• a system console (including software and control electronics);
• a control and display panel;
• a detachable handpiece with integrated skin cooling;
• a foot-operated exposure switch (footswitch); and
• a remote interlock connector (disables emission when treatment room door is opened).

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.

The provided information describes a 510(k) submission for the Cutera Titan Tabletop Product. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable to this submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Not applicable. This 510(k) submission demonstrates substantial equivalence to existing cleared devices rather than providing specific performance metrics against pre-defined acceptance criteria from a new study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new clinical trials or studies with test sets were conducted for this 510(k) submission. The evidence relies on the substantial equivalence to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new clinical trials or studies requiring expert-established ground truth were conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new clinical trials or studies with test sets were conducted.

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 treatment product, not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical infrared treatment product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new clinical trials or studies requiring ground truth were conducted for this 510(k) submission.

8. The sample size for the training set

Not applicable. This submission is not for an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This submission is not for an AI/machine learning model that requires a training set.

Summary of the K042165 Submission for the Cutera Titan Tabletop Product:

The Cutera Titan Tabletop Product gained 510(k) clearance by demonstrating substantial equivalence to existing, legally marketed predicate devices. The core argument for substantial equivalence is based on:

• Identical Indications for Use: The new device shares the exact same indications for use as the previously cleared infrared handpiece (K033768). These indications include temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles, as well as helping muscle spasms, minor sprains, strains, and minor muscular back pain.
• Technological Substantial Equivalence: The Cutera Titan Tabletop Product consists of a modified console designed to drive an existing, FDA-cleared infrared handpiece (with a variable emission of 0.8 to 2.0 microns, filtered to 1100nm - 1800nm). The console (K023954) and the infrared handpiece (K033768) are both previously cleared components.
• Comparable Risks and Benefits: Due to the identical indications for use and technological similarity to predicate devices, the manufacturer argued that the risks and benefits are comparable and that no new questions of safety or effectiveness are raised.

Therefore, the "study" proving the device meets acceptance criteria, in this context, is the comparison and justification of substantial equivalence to the predicate devices (Cutera Optional Infrared Handpiece K033768 and the base console K023954), as outlined in the 510(k) summary. This process relies on regulatory review of design, materials, and functional specifications against established predicates, rather than new clinical data against specific performance metrics.

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