(90 days)
The EBI Spinal Endoscopic System is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.
The EBI 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 text describes a 510(k) summary for the EBI Spinal Endoscopic System. It does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the types of quantitative data requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or detailed ground truth types).
The document is a premarket notification for a medical device (arthroscope) stating its intended use and claiming substantial equivalence to predicate devices already on the market. It mentions "bench testing demonstrates that the device meets its functional requirements" but does not elaborate on what those functional requirements are or present the results of such testing.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.
However, I can provide what information is available about the "study" (bench testing) and general claims:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements (specifics not provided) | Bench testing demonstrates the device meets its functional requirements. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (implied to be internal company bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This was bench testing, not a clinical study involving expert assessment of patient data.
4. Adjudication method for the test set
- Not applicable/Not specified.
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, an MRMC study was not done. This device is an arthroscope, not an AI diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical endoscopic system, not an algorithm.
7. The type of ground truth used
- For "functional requirements," ground truth would typically be engineering specifications, measurements, or established performance benchmarks for similar devices, which are not detailed here.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.