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The Auriga QI laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of: laser system including control panel (user interface), foot switch, application fiber.

The provided 510(k) summary for the Auriga QI laser system does not include acceptance criteria or a study that evaluates the device's performance against such criteria. The document explicitly states:

"No clinical information is required."

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Auriga XL, K111475) through laboratory testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Here's a breakdown of why each specific point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "all design specifications" were met through laboratory testing, but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not provided. Only "laboratory testing" is mentioned, without details on sample sizes or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical study requiring expert ground truth for a test set.
4. Adjudication method for the test set: Not applicable for the same reason as above.
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 system, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical data or ground truth establishment is described for performance evaluation.
8. The sample size for the training set: Not applicable for a traditional medical device submission that does not involve machine learning or AI.
9. How the ground truth for the training set was established: Not applicable.

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The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery

The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength of approximately 2.1 um. The laser power transfers an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of:

• laser system including control panel (user interface)
• foot switch
• application fiber

This submission is for a laser surgical instrument (Auriga XL) and does not describe acceptance criteria for a diagnostic device based on performance metrics such as sensitivity, specificity, or AUC. Instead, the performance testing focuses on compliance with established safety and performance standards for medical devices. Therefore, I cannot generate the requested table and information about elements such as sample size, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of why along with the available information:

Reasoning for inability to provide requested details:

The provided text describes a 510(k) submission for a surgical laser instrument (Auriga XL). The "performance testing" section, as stated in the document, focuses on compliance with various ISO and IEC standards related to medical device safety, electrical safety, electromagnetic compatibility, usability, and laser safety. This is typical for a device of this nature, where the primary concern for regulatory approval is safe and effective operation within defined parameters, rather than the diagnostic accuracy of an algorithm.

Therefore, the concepts of:

• A table of acceptance criteria and reported device performance (in terms of diagnostic metrics)
• Sample size for test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm-only) performance
• Type of ground truth (expert consensus, pathology, outcomes)
• Sample size for training set
• How ground truth for training set was established

...are not applicable to this type of device and submission, as it is not an AI/ML diagnostic or imaging interpretation device.

Information Extracted from the Document (related to "performance"):

1. Acceptance Criteria and Device Performance (based on standards compliance):

Regarding other specific questions:

• 2. Sample size used for the test set and the data provenance: Not applicable. The "testing" refers to compliance with engineering and safety standards, not a diagnostic test on a data set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here.
• 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, as this is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical laser, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its ability to safely and effectively perform its stated functions according to engineering specifications and safety standards.
• 8. The sample size for the training set: Not applicable. There is no training set for an algorithm in this submission.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on regulatory compliance for a physical medical device (a surgical laser), not the performance evaluation of a diagnostic algorithm or AI system.

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The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The vela® XL is thulium laser system, which emits laser radiation with a wavelength of approximately 1.9 µm. The laser power transfers an optical application fiber. The indications are dissection, ablation, resection and coagulation of tissue. The laser system consists of: - laser system including control panel (user interface) - foot switch - application fiber

The provided document is a 510(k) summary for the StarMedTec vela® XL laser system. It details the device's intended uses and provides information about performance testing. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness from a multi-reader, multi-case study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific accuracy thresholds, rates of success for procedures). Instead, the performance testing described focuses on compliance with established standards and substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical information is required." This means there was no clinical "test set" of patients or cases used for performance evaluation in the context of this 510(k) submission. The evaluation was based on laboratory testing and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical test set was required or used for performance evaluation in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was required or used for performance evaluation in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC comparative effectiveness study was reported in this document. The submission states that "No clinical information is required."

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

Not applicable. The vela® XL is a laser surgical instrument, an active device used by a human practitioner. It's not an "algorithm only" device in the sense of AI-driven diagnostic software. Its performance is intrinsically linked to its operation by a human user during surgical procedures. The performance evaluation focuses on the device's technical specifications and safety rather than independent algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by demonstrating its compliance with technical standards and its substantial equivalence to an already legally marketed predicate device (Lisa Laser Products – Revolix 120 Laser System, K070476). This relies on:

• Engineering and laboratory test data confirming design specifications.
• Regulatory assessment of the similarities and differences between the new device and the predicate device, with respect to indications for use, technological characteristics, and safety/effectiveness profiles.

8. The Sample Size for the Training Set

Not applicable. As this is a medical device approval based on substantial equivalence and laboratory testing, there is no "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in this context.

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