(190 days)
Intended for stone fragmentation, incision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.
The Cook Holmium Laser Fibers are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in four different sizes, and will be sold in boxes of three.
The provided document is a 510(k) premarket notification for a medical device called the "Cook Holmium Laser Fiber." It details the device's indications for use, comparison to predicate devices, and performance testing. However, it does not describe acceptance criteria for an AI/Software as a Medical Device (SaMD), nor does it present a study proving a device meets acceptance criteria related to AI performance, ground truth establishment, expert review, or statistical measures typical for AI/SaMD studies.
The document is for a physical medical device (a laser fiber), and the "performance data" refers to engineering and compatibility tests (e.g., laser system compatibility, sterilization validation), not clinical performance or AI algorithm performance.
Therefore, I cannot extract the information required for your request from this document, as it pertains to a different type of medical device and regulatory submission.
Specifically, the document does not contain information on:
- Table of acceptance criteria and reported device performance (for an AI/SaMD): The document lists performance tests related to physical properties (compatibility, sterilization) but no performance metrics like sensitivity, specificity, AUC, etc., nor acceptance thresholds for such metrics.
- Sample size for test set and data provenance: Not applicable to a physical device performance test of this nature.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: No ground truth in the AI/SaMD sense is established.
- Sample size for training set: No AI model training is mentioned.
- How ground truth for training set was established: Not applicable.
To answer your request, you would need a document detailing the regulatory submission for an AI/SaMD, which would typically include clinical study data, performance metrics, and details about the dataset and ground truth establishment.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.