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Intended Use: The Nd: Yag Laser Therapy Systems is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle

Nd:Yag Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.
The Nd: Yag laser therapy systems is mainly composed of a host, an operating hand tool and a foot switch. The operation hand is a treatment hand. The host is composed of a power module, a control module and a display module.

I apologize, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

The document you provided is an FDA 510(k) clearance letter and an associated 510(k) Summary for a Nd:Yag Laser Therapy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific performance criteria through clinical studies in the way you've described for, for example, an AI/ML software as a medical device.

Here's why the requested information isn't present in this document:

• Type of Device: This is a laser hardware device, not an AI/ML algorithm. The performance evaluation focuses on physical parameters (wavelength, pulse energy, etc.) and compliance with electrical, EMC, and laser safety standards.
• 510(k) Process: The 510(k) pathway (Traditional, Abbreviated, or Special) primarily relies on demonstrating that the new device is "substantially equivalent" to a predicate device. This often involves comparing technological characteristics, intended use, and non-clinical performance data (like compliance with recognized standards).
• Lack of Clinical Studies: The "10. Clinical Test Conclusion" section explicitly states: "No clinical study is included in this submission." This means there was no human clinical trial to assess the device's effectiveness or safety in patients, which would typically be required for an AI/ML device to demonstrate performance against acceptance criteria in a real-world scenario.
• No AI/ML Specifics: There's no mention of AI/ML, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human reader studies (MRMC, standalone algorithm performance) because this device does not perform those functions.

Therefore, the document does not contain the information required to answer your specific questions regarding acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device.

The tables provided (Table 1: General Comparison, Table 2: Performance Comparison, Table 3: Safety Comparison) compare the characteristics of the proposed device to a predicate device and a reference device to demonstrate substantial equivalence, focusing on physical and safety parameters, not diagnostic or AI performance.

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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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