(42 days)
Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.
The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.
The provided text describes the 510(k) submission for the OptiLite™ Holmium Laser Fibers. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding specific acceptance criteria for device performance, the study design for such performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.
The document indicates that the device's substantial equivalence is based on its similarity to existing predicate devices regarding "indications for use and technology," and that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." However, the details of these performance tests and their specific acceptance criteria are not included in the provided text.
Therefore, I can only provide information based on what is explicitly stated or can be inferred from the text. Many sections of your request will be answered with "Not provided in the text."
Acceptance Criteria and Study Details for OptiLite™ Holmium Laser Fibers
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Functionality: - Deliver laser energy from proximal to distal end for incision/excision, ablation, and coagulation. "The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end." No specific quantitative metrics for energy delivery or efficacy are provided. Performance testing was done, but specific results or acceptance thresholds are not detailed. Biocompatibility: "Biocompatibility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported. Sterility: "Sterility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported. Compatibility: (with specific laser systems) "Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared." No specific performance metrics or acceptance criteria for this compatibility are detailed. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the text. The document only states that "Performance testing were performed," but no details on the sample size (e.g., number of fibers tested, number of procedures simulated), type of data, or provenance are given.
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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 / Not provided in the text. This type of information is typically relevant for AI/imaging devices involving interpretive tasks. For a laser fiber, the "ground truth" would be established through engineering and biological performance standards, not expert adjudication of images. The text does not mention any expert involvement in establishing ground truth for performance testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided in the text. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation. This is not relevant for the described performance testing of a laser fiber.
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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 / Not provided in the text. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. The OptiLite™ Holmium Laser Fiber is a medical device for delivering laser energy, not an AI or imaging device, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided in the text. This question is also relevant for AI/algorithm-based diagnostic devices. The OptiLite™ Holmium Laser Fiber is a physical medical device. Its "standalone performance" refers to its ability to function as designed (deliver laser energy, biocompatibility, sterility) which was stated as having been tested.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on engineering and biological performance standards. The text indicates "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." This implies that the "ground truth" for evaluating the device's performance would be established by predefined engineering specifications (e.g., laser energy transmission efficiency, damage thresholds) and biological safety standards (e.g., cytotoxicity, irritation). No mention of expert consensus, pathology, or outcomes data for establishing the performance 'ground truth' is made.
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The sample size for the training set
- Not applicable / Not provided in the text. Training sets are used in machine learning and AI. This device is a physical, non-AI medical device; therefore, no training set in the AI sense would be used. The text does not mention any data sets used for "training" the device.
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How the ground truth for the training set was established
- Not applicable / Not provided in the text. As explained above, this device does not involve a training set in the context of AI.
§ 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.