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Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

The provided text is a 510(k) summary for a medical device called "Scanning Device Accessory for the CB Diode/532TM Nd:YAG Laser." It explicitly states that no nonclinical or clinical performance data was provided. Therefore, no acceptance criteria or studies proving the device meets those criteria are mentioned.

Here's an analysis based on the information provided:

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

   • Acceptance Criteria: Not specified.
   • Reported Device Performance: Not reported.

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 as no clinical or nonclinical performance data was provided.

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 no clinical or nonclinical performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

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 scanning accessory for a laser, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

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

   • Not applicable. This device is hardware, not an algorithm. No standalone performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

8. The sample size for the training set

   • Not applicable as no clinical or nonclinical performance data was provided. This device is hardware and not related to machine learning algorithms requiring training sets.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

Conclusion from the provided text:

The 510(k) summary explicitly states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

The basis for clearance was a comparison to an equivalent predicate device, the SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684). The submission primarily focused on demonstrating substantial equivalence to this already cleared device. The "Conclusion" section states: "The Scanning Device Accessory for the CB Diode/532TM Nd: YAG Laser enhances the clinical application procedure while maintaining the performance characteristics," implying that its performance is presumed to be similar to its predicate.

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