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The Diode laser therapy system is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode laser therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black).

The provided text describes a 510(k) submission for a medical device, the "Diode laser therapy system," which is intended for permanent hair reduction.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

   The document does not explicitly present a table of acceptance criteria and reported device performance in the way a diagnostic AI would have with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by the comparison to a predicate device (K210168, Diode Laser Therapy Systems by Beijing Kes Biology Technology CO., LTD.) and compliance with relevant non-clinical standards.

   The "performance" is primarily demonstrated through this substantial equivalence comparison and through non-clinical testing.

   Here's a summation of the comparison table provided, which implicitly serves as the performance assessment against the predicate:

   Item	Acceptance Criteria (Predicate K210168)	Reported Device Performance (Proposed Device K212978)	Remark
   Product Code	GEX	GEX	Same
   Regulation No.	21 CFR 878.4810	21 CFR 878.4810	Same
   Class	II	II	Same
   Indications for Use	Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment.	Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment.	Same
   Configuration	Main Unit, Handpiece, Foot Control	Main Unit, Handle, Foot Control	Same
   Laser Type	Diode Laser	Diode Laser	Same
   Laser Classification	Class IV	Class IV	Same
   Laser Wavelength	808 nm	808 nm	Same
   Spot Size	12 mm × 12 mm = 1.44 cm²	1.2 cm × 2.4 cm = 2.88 cm²	Different
   Fluence	10-125 J/cm²	10-120 J/cm²	Different
   Frequency	1-10 Hz	1-10 Hz	Same
   Pulse Duration	10-400 ms	10-300 ms	Different
   Power Supply	99V-121V, 50/60Hz, 1400VA	AC 100~230V/50/60Hz, 2000VA	Different
   Dimension	450 × 430 × 1000 mm	430 × 500 × 1030 mm	Different
   Weight	52 kg	65 kg	Different
   Patient contact material	Aluminum alloy, ABS	Aluminum alloy, Sapphire	Different
   Cytotoxicity	No Cytotoxicity (Comply with ISO 10993-5:2009)	No Cytotoxicity (Tested according to ISO 10993-5:2009)	Same
   Sensitization	No evidence of Sensitization (Comply with ISO 10993-10:2010)	No evidence of Sensitization (Tested according to ISO 10993-10:2010)	Same
   Irritation	No evidence of Irritation (Comply with ISO 10993-10:2010)	No evidence of Irritation (Tested according to ISO 10993-10:2010)	Same
   Electrical Safety	Comply with ANSI/AAMI ES60601-1:2005, IEC 60601-2-22	Comply with ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R) 2012 and IEC 60601-2-22:2012, IEC 60825-1:2014	Same
   EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2:2014	Same
   Software Validation & Verif	N/A (implied by predicate clearance)	Software verification & validation conducted as per FDA guidance for "Moderate" level of concern.	N/A (New test)

   Explanation for "Different" remarks: The document states that despite the differences, non-clinical tests were conducted to demonstrate that these differences do not affect the safety and effectiveness of the proposed device. For example:

   • Spot Size: Non-clinical tests were done, and the results show the proposed device meets requirements.
   • Fluence: The proposed device's fluence range is within the predicate's range.
   • Pulse Duration: The proposed device's pulse duration range can be covered by the predicate's range.
   • Power Supply: Electrical safety and EMC tests were conducted, and the device works normally.
   • Dimension and Weight: These are physical specifications and do not raise safety/effectiveness issues.
   • Patient contact material: Biocompatibility tests met ISO 10993 requirements.

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

   The document explicitly states: "No clinical study is included in this submission."
   Therefore, there is no clinical test set, sample size, or data provenance related to clinical performance. The evaluation is based on non-clinical testing and substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   Since no clinical study was performed, there was no clinical "test set" and thus no experts or ground truth established for clinical performance as would be the case for a diagnostic AI device.

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

   Not applicable, as no clinical test set or human interpretation was involved.

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. The device is a laser therapy system, not a diagnostic AI system that assists human readers.

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

   Not applicable. The device is a physical laser therapy system, not a standalone AI algorithm. It operates as a medical instrument for treatment.

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

   For the non-clinical tests, the "ground truth" or reference was compliance with international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility, IEC 60825-1 for laser safety) and demonstrating that parameter differences did not negatively impact safety and effectiveness compared to the predicate.

8. The sample size for the training set

   Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for such a device would be its design and manufacturing process to meet specifications and standards.

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

   Not applicable for the same reason as above.

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