(72 days)
The 2600 endoscope is intended for accessing and visualizing the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the lumbar spine. The endoscope has a working channel intended for the passage of surgical instruments indicated for use in this area. Surgical instrumentation may be used for discectomy procedures, bone and osteophyte removal, procedures associated with ruptured or herniated discs such as, retrieval of extruded disc fragments and retrieval of free fragments. The Model 2600 also has an irrigation channel for sterile fluid flush or aspiration.
The Model 2600 Neuro Endoscope is manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the Model 1103 Laser Endoscopic Disc Decompression Kit, the Model 2230 Neuro Endoscope, and the Model 2125 Endoscopic Ball Probe. Further, the sizes and configurations of the endoscope and accessories are equivalent as well.
The Model 2600 Neuro Endoscope is a rigid fiber optic endoscope with a molded proximal handle. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope has a working channel and a separate fluid irrigation channel.
The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok connector. The working channel has a proximal port to allow the passage of surgical instruments.
This 510(k) summary for the Clarus Model 2600 Neuro Endoscope does not contain the detailed information necessary to fully answer the request. The document describes a traditional medical device (an endoscope) and its testing, which focuses on biocompatibility and physical performance, rather than algorithm performance.
Therefore, many sections of your request related to AI/algorithm performance (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All materials passed Biocompatibility testing and are suitable for this application. |
| Physical Testing | All testing of the product yielded acceptable results. |
| Dimensional inspection | Acceptable results |
| Weld strength testing | Acceptable results |
| Optical clarity | Acceptable results |
| Light transmittance | Acceptable results |
| Fluid flow rate | Acceptable results |
Note: The document states "All testing of the product yielded acceptable results" for physical testing, implying these were the acceptance criteria. Specific numerical acceptance thresholds are not provided.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The testing described is for the physical and biological properties of the device itself (materials, construction), not for diagnostic performance using a test set of data/images.
- Data provenance: Not applicable in the context of diagnostic performance data. The tests are performed on the device components/product samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a surgical endoscope, not an AI/diagnostic algorithm. Its performance is assessed through engineering and biocompatibility tests, not by comparing its diagnostic output to expert-established ground truth on a dataset.
4. Adjudication method for the test set
- Not applicable. See point 3.
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
- No. This is not an AI-powered diagnostic device. No MRMC study was conducted or is relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of diagnostic performance. For biocompatibility, "ground truth" is established by relevant ISO standards and test methods. For physical testing, "ground truth" is established by design specifications and engineering standards.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary regarding AI/Algorithm specific questions:
The provided 510(k) summary describes a standard medical device (a neuro endoscope) and its physical and biocompatibility testing. It predates widespread clinical AI applications (filed in 1997, cleared in 1998). Therefore, the questions related to AI/algorithm performance (test sets, training sets, ground truth for data, expert adjudication, MRMC studies) are not relevant to this submission and cannot be answered from the text. The "testing" section refers to manufacturing quality control and material safety, not diagnostic performance of an algorithm.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.