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510(k) Data Aggregation
(124 days)
AURIGA XL
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):
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 14971:2006 (Risk Management) | The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported in this summary). |
| IEC 60601-1:2005 (Medical Electrical Equipment - General requirements for basic safety and essential performance) | The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported). |
| IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic compatibility) | The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported). |
| IEC 60601-1-6:2006 (Medical Electrical Equipment - Usability) / IEC 62366:2007 (Medical Devices - Application of usability engineering to medical devices) | The Auriga XL is tested according to these standards. (Implies compliance regarding user interface and design, no specific performance metrics reported). |
| IEC 60601-2-22:2005 (Medical Electrical Equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | The Auriga XL is tested according to this standard. (Implies compliance specific to laser safety and performance for surgical lasers, no specific performance metrics reported). |
| IEC 60825-1:2007 (Safety of laser products - Equipment classification and requirements) | The Auriga XL is tested according to this standard. (Implies compliance with general laser product safety, no specific performance metrics reported). |
| IEC 62304:2006 (Medical device software - Software life cycle processes) | The Auriga XL is tested according to this standard. (Implies compliance with software development and safety for medical devices, no specific performance metrics reported). |
| European Medical Device 93/42/EEC + Amendment 2007/47/EC | The device also complies with this directive. (Implies overall conformity with European medical device regulations, no specific performance metrics reported). |
| Design Specifications | "Laboratory testing was conducted to verify and validate that the Auriga XL met all design specifications." (No specific design specifications or corresponding performance metrics are detailed in this summary). |
| Substantial Equivalence to Predicate Device (Lisa Laser Products - Sphinx, K033437) | "The Auriga XL is as effective and safe as the predicate device. The Auriga XL is substantially equivalent to the cited legally marked predicate device." (This is the ultimate conclusion, not a performance metric itself). |
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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