(102 days)
The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.
The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.
The Integra Spine Instrument System for Endoscopic Spinal Surgery is an assembled, comprehensive set of instruments for use in endoscopic decompression techniques. The instrument set includes guide wires, pituitaries, ronguers, trephines, trocar / dilators, cannulas, reamers, dural elevator, nerve hook, mallet, forceps, chisels, and associated handles. The instrument set will be used with an FDA cleared endoscope with a length of no more than 254mm and working channel of at least 4.1mm.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Specifications) | Reported Device Performance |
|---|---|
| Individual instrument functions performed as designed. | All instruments performed as designed. |
| All product specifications met or exceeded. | All instrument specifications met or exceeded. |
2. Sample Sized Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved verification of individual instrument functions and a cadaver study.
- Data Provenance: The cadaver study was performed with a cadaver (human cadaver), indicating a form of retrospective human anatomical testing in a controlled environment. The country of origin for the cadaver or the specific institution is not given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One surgeon.
- Qualifications of Experts: The surgeon was described as "skilled in percutaneous and endoscopic spinal procedures." No further details on years of experience or specific board certifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Implicitly, "none" in the traditional sense of multiple reviewers. The evaluation of instrument performance was conducted by a single "skilled surgeon" in the cadaver setting. There is no mention of a consensus process between multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument system, not an imaging or diagnostic device that typically undergoes MRMC studies.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Yes, in a manner applicable to a surgical instrument. "Mechanical testing consisted of verification testing of the individual instrument functions." This can be considered a standalone evaluation of the instruments' physical properties and operational capabilities without direct human surgical interaction beyond the test setup. The cadaver study then integrated human users, but the mechanical testing itself was standalone.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was based on the design specifications and intended functionality of the physical instruments. In the cadaver study, the ground truth was essentially the successful and satisfactory performance of the instruments during simulated surgical procedures as observed and judged by a skilled surgeon. It is a functional efficacy ground truth within a simulated surgical environment.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a manual surgical instrument system, not an AI/ML-based device that would typically have a "training set" in the computational sense. The device's design is based on established surgical principles and predicate devices, refined through engineering and testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned, there is no "training set" in the context of an AI/ML device. The "ground truth" for the development and design of these instruments would stem from anatomical and physiological knowledge, surgical best practices, and the performance characteristics of existing predicate devices. This would have been established through years of medical knowledge development and engineering experience, not through a specific formal "ground truth establishment" for a data set.
§ 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.