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The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.

This document describes the premarket notification (510(k)) for the CO2 Laser Therapy Systems (K162398). The submission focuses on demonstrating substantial equivalence to a predicate device (CO2 Laser Therapy Machine, K161925) rather than providing a study where the device meets specific performance acceptance criteria from a clinical trial.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because such a study is not part of this 510(k) summary. Instead, the document provides non-clinical performance data (biocompatibility, electrical safety, EMC, and software verification/validation) to support safety and effectiveness and substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical performance metrics like sensitivity, specificity, accuracy, or a reduction in wrinkles of a certain percentage) that the device was evaluated against in a clinical study. Instead, the performance data provided are non-clinical performance tests demonstrating compliance with recognized standards.

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

Not applicable. No clinical test set or patient data (retrospective or prospective) was used for this 510(k) submission. The performance testing described is non-clinical (biocompatibility, electrical safety, EMC, software).

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

Not applicable. No clinical test set requiring expert-established ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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 a CO2 laser therapy system, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

Not applicable. This device is a CO2 laser therapy system, not an AI algorithm.

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

Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission as no clinical studies were performed. The "ground truth" for the non-clinical tests was compliance with the specified international standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. This is a physical medical device (CO2 laser).

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

Not applicable. As noted above, this is not an AI/machine learning device.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating that the CO2 Laser Therapy Systems is substantially equivalent to a predicate device (K161925) and meets all applicable non-clinical safety standards. This is the primary method for demonstrating safety and effectiveness in a 510(k) submission when clinical studies are not deemed necessary by the FDA.

• Comparison of Technological Characteristics: A detailed table compares the proposed device with the predicate device across various specifications (Output power, Work mode, Laser medium/energy source, CO2 laser wavelength, Aiming Beam wavelength and power, Spot Size, Dot Quantity, Pulse Energy, Pulse Length, Cooling, Patient contact sites, Control System, Laser Operation, Power input). The conclusion is that differences do not raise new questions of safety and effectiveness.
• Non-Clinical Performance Data:
  • Biocompatibility: The device components that contact the patient were tested and found to be biocompatible according to recognized standards (ISO 10993-1).
  • Electrical Safety & EMC: The device complies with IEC 60601-1 and IEC 60601-1-2 standards, ensuring electrical safety and electromagnetic compatibility.
  • General Performance Testing: The device was tested according to IEC 60825-1, a standard for the safety of laser products.
  • Software Verification and Validation: Software testing was conducted, and it was deemed a "moderate" level of concern, with documentation provided as per FDA guidance.
• No Clinical Studies: The submission explicitly states, "The subject of this premarket submission, CO2 Laser Therapy Systems, does not require clinical studies to support substantial equivalence." This is why there is no information on clinical acceptance criteria or studies.

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The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.

The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

The provided document is a 510(k) summary for the Beijing Sincoheren Science And Technology Development Co.'s Q-Switched Nd:YAG Laser Therapy Systems. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety or effectiveness. Therefore, the document discusses performance data in the context of equivalence rather than proving acceptance criteria for a novel device.

The document does not describe specific acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy) for a new clinical indication or a new type of device. Instead, it relies on demonstrating that the performance characteristics of the proposed device are comparable to or better than those of the predicate device, and that it complies with relevant safety standards.

Here's an analysis of the provided information based on your requested points, framed within the context of a 510(k) submission for substantial equivalence:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device performs at least as well as, or is sufficiently similar to, the predicate device in terms of technical specifications and safety. The reported device performance is presented as a comparison table against the predicate device.

In addition to these direct comparisons, the submission outlines compliance with various safety and performance standards as "performance data" to support the substantial equivalence claim:

• Biocompatibility testing: Compliance with ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests. (Implicit acceptance criteria: device materials must be biocompatible according to recognized standards for skin and subcutaneous tissue contact < 24 hours).
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). (Implicit acceptance criteria: device must meet electrical safety and EMC standards).
• Performance testing: Compliance with IEC 60825-1 (laser safety). (Implicit acceptance criteria: laser performance must meet safety standards).
• Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implicit acceptance criteria: software must be verified and validated according to FDA guidance for its risk level).

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 does not specify a "test set" in the context of clinical or image-based studies. The performance data presented are primarily technical specifications and compliance with international standards, not data from a clinical test set. Therefore, information on sample size and data provenance for a test set is not applicable to this submission as described.

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)

Not applicable, as there is no clinical or image-based "test set" described with ground truth established by experts.

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

Not applicable, as there is no clinical or image-based "test set" requiring adjudication.

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 a laser therapy system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

Not applicable. This is a physical laser device, not an algorithm.

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

Not applicable. For this type of device and submission, the "ground truth" for demonstrating substantial equivalence lies in meeting established engineering standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993-1) and demonstrating comparable basic technical performance to a legally marketed predicate device for the same indications for use. There is no biological "ground truth" involved in the sense of clinical validation of a diagnostic or treatment outcome for this specific 510(k) submission.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set.

In summary:

This 510(k) submission primarily relies on bench testing, compliance with recognized international standards (IEC, ISO), and a direct comparison of technical specifications to a predicate device to demonstrate substantial equivalence. It does not involve experimental clinical studies, human reader studies, or AI algorithm validation data that would typically require "test sets," "ground truth," or "training sets" as you've defined them. The "acceptance criteria" are effectively met by demonstrating that the device is technically comparable or improved (e.g., safer, more effective according to physical principles) for the same intended use as a legally marketed predicate device, and that it adheres to relevant safety and performance standards for medical lasers.

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