(185 days)
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.
The Cook Holmium Laser Fiber is intended for incision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared. The devices 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 six sizes, and will be sold in boxes of three.
The provided text describes a 510(k) submission for the Cook Holmium Laser Fiber. This type of submission is for medical devices, not AI/ML algorithms, so many of the requested fields are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Bend Radius Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Energy Loss Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Accelerated Aged Testing | Results provide reasonable assurance of design and conformance to intended use. |
| Biocompatibility Testing | Results provide reasonable assurance of design and conformance to intended use. |
Note: The document states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria and detailed performance metrics are not provided in this summary document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The tests listed are for verifying the physical and functional properties of the laser fiber itself, not for assessing performance on a dataset of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a laser fiber and it does not use a ground truth established by experts in the context of medical image analysis or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing described.
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
This information is not applicable as the device is a medical instrument (laser fiber), not an AI/ML diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" for a physical device like a laser fiber typically involves engineering specifications and performance standards rather than clinical diagnostic ground truth.
8. The sample size for the training set
This information is not applicable as there is no training set for a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved in the development or clearance of this type of medical device.
§ 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.