(83 days)
The EBI VueCath™ Spinal Endoscopic System is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.
The EBI VueCath™ Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adaptors.
The provided document is a 510(k) summary for the EBI VueCath™ Spinal Endoscopic System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, studies proving device performance against those criteria, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.
Instead, the document primarily focuses on establishing substantial equivalence to existing legally marketed devices based on design, materials, and intended use, and mentions "bench testing demonstrates that the device meets its functional requirements" without providing specifics of that testing.
Therefore, much of the requested information cannot be extracted from this document. I will fill in the requested sections with "Not provided in the document" where the information is absent.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specifically stated (e.g., optical resolution, illumination intensity, catheter flexibility, insertion force) | "bench testing demonstrates that the device meets its functional requirements." (No specific quantitative performance metrics provided.) |
Study Information
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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 document. The document only vaguely refers to "bench testing."
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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. The document does not describe studies involving human interpretation or ground truth establishment by experts. The "bench testing" likely refers to engineering or materials testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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
- No MRMC study was mentioned. This device is an arthroscope, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The document refers to "bench testing" for functional requirements, not clinical ground truth.
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The sample size for the training set
- Not applicable/Not provided. No training set is mentioned as this is a physical device, not a machine learning model.
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How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.