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Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology.

Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm and 1064nm wavelength, respectively

The provided text is related to a 510(k) summary for the Fox Q-810, Q-980, and Q-1064 Lasers. It outlines regulatory compliance and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, device performance from a study, sample sizes, expert involvement, or specific ground truth methods as would be found in a clinical or performance study report for an AI/ML medical device.

The document is a regulatory submission for a traditional medical device (diode laser) and focuses on demonstrating substantial equivalence to previously cleared devices and compliance with established performance standards (e.g., 21CFR 1040.10, IEC 60601-1). It deals with the inherent physical safety and performance of the laser itself, not an AI algorithm.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The device complies with "performance requirements of 21CFR 1040.10 and 1040.11, with permissible deviations defined in Laser Notice 50, dated July 26, 2001." It also complies with "IEC 60601-1:1998 including amendment 1, IEC 60601-2-22:1995, and IEC 60825-1:1993 including amendments 1 and 2." These are general safety and performance standards for lasers and medical electrical equipment, not specific criteria for an AI/ML algorithm's diagnostic or predictive performance.
• Reported Device Performance: The document states the device "generates energy in the 980 nm range" (and 810 nm, 1064 nm for other models) and "Fibers deliver energy to the tissue." It doesn't report specific performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcome statistics) that would necessitate an acceptance criterion table as requested for an AI/ML study. The "performance" here refers to meeting safety and output specifications according to the listed standards.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm or ground truth established by experts in that context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 surgical instrument, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical laser, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical specifications and safety compliance, not medical diagnostic outcomes.

8. The sample size for the training set: Not applicable. This device is a physical laser, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• 21CFR 1040.10 and 1040.11 (with deviations from Laser Notice 50, dated July 26, 2001)
• IEC 60601-1:1998 (including amendment 1)
• IEC 60601-2-22:1995
• IEC 60825-1:1993 (including amendments 1 and 2) |
  | Reported Device Performance | The device "uses diodes to generate energy in the [specified] nm range" (e.g., 980 nm, 810 nm, 1064 nm) and "Fibers deliver energy to the tissue." The performance is implied by its adherence to the above-listed standards, ensuring its safety and intended function as a medical laser. No specific quantitative performance metrics (e.g., accuracy, reliability in a clinical setting) are provided as would be for an AI/ML device. |
  | Study Type to Prove Acceptance | The document indicates a substantial equivalence (510(k)) review process, not a specific performance study in the context of AI/ML. The conclusion explicitly states: "The Fox 810, 980 and 1064 Lasers are substantially equivalent to the predicate devices. They have similar intended uses and comply with the same safety and performance standards." This implies that compliance with safety and performance standards was demonstrated through testing against those standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or predictive performance. |
  | Sample size (test set) | Not applicable. (No AI/ML test set) |
  | Data provenance (test set) | Not applicable. (No AI/ML test set) |
  | Number of experts for ground truth | Not applicable. (No AI/ML ground truth) |
  | Adjudication method | Not applicable. (No AI/ML test set) |
  | MRMC comparative effectiveness study | No. |
  | Standalone performance study | Not applicable. (No AI/ML algorithm) |
  | Type of ground truth used | For a laser, "ground truth" relates to its physical specifications, power output, wavelength accuracy, and safety features meeting established engineering and regulatory standards. Not expert consensus on medical images or patient outcomes in the context of performance study. |
  | Sample size (training set) | Not applicable. (No AI/ML training set) |
  | How ground truth for training set was established | Not applicable. (No AI/ML training set) |

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