(29 days)
The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems.
The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual. The primary changes from the cleared eSPIN are: Addition of Suction tube and irrigation system. Minor modifications to the device design.
Here's a breakdown of the acceptance criteria and study information for the NLT SPINE's eSPIN device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Study/Test Conducted) |
|---|---|
| Mechanical/Physical Performance: | |
| Bending mechanism durability of manipulator unit | Testing demonstrated durability. |
| Verification of tip bending angle | Testing verified the tip bending angle. |
| Verification of discectomy cleaning work limits | Testing verified the discectomy cleaning work limits. |
| Verification of motor parameters (when connected to electrical motor/drill) | Testing verified motor parameters. |
| Tip attachment strength under tensile force | Testing demonstrated sufficient tip attachment strength. |
| Durability of tip bristle and tip under rotational and tensile loading | Testing demonstrated durability under specified loading conditions. |
| Biocompatibility: | |
| Biocompatibility for Intended Use | Evaluation conducted in accordance with ISO 10993; deemed biocompatible. |
| Clinical Performance (Safety & Efficacy related): | |
| Confirmation that the device does not breach annulus | Cadaver studies conducted to evaluate for annulus breach. |
| Confirmation of radiopacity of tip under X-ray | Cadaver studies conducted to confirm tip radiopacity. |
| No new questions of safety or effectiveness raised by modifications | Performance data demonstrated the device is as safe and effective as the predicate, despite minor technological characteristics. |
| Substantial Equivalence to Predicate Device | Overall conclusion that the device is substantially equivalent to K120553. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a numerical sample size for the test set of the specific performance tests (e.g., how many manipulator units were tested, how many tips were tested, how many cadavers were used).
- Test Set Description: The "Performance Data" section lists several types of tests:
- Bending mechanism durability of manipulator unit
- Verification of tip bending angle
- Verification of discectomy cleaning work limits
- Verification of motor parameters
- Tip attachment strength under tensile force
- Durability of tip bristle and tip under rotational and tensile loading
- Biocompatibility evaluation
- Cadaver studies
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a medical device modification, these would typically be internal, prospective verification and validation tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts being used to establish "ground truth" in the traditional sense for these performance tests. The tests described are engineering and biocompatibility evaluations, as well as cadaver studies, which rely on established measurement techniques, protocols, and scientific standards.
- Regarding the cadaver studies: While general medical expertise would be involved, the document does not specify the number or qualifications of experts for judging annulus breach or radiopacity. These are objective observations.
4. Adjudication Method for the Test Set
Not applicable. The described tests are primarily objective performance verification and validation tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices and involves human readers interpreting cases with and without AI assistance to measure reader improvement. The eSPIN is a surgical instrument.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance tests described are essentially "standalone" in that they evaluate the device's physical and mechanical capabilities independently. The device itself (the eSPIN) is the "algorithm" in this context, and its performance characteristics were assessed. There is no AI algorithm being evaluated in this submission.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is based on:
- Engineering specifications and standards: For mechanical durability, bending angles, work limits, motor parameters, strength, and durability.
- International standards (ISO 10993): For biocompatibility.
- Direct observation and measurement: For annulus breach (in cadaver studies) and radiopacity (in cadaver studies).
- Predicate device's established performance: The overall goal of the submission is to demonstrate substantial equivalence to the predicate, implying that the predicate's performance serves as the benchmark or "truth" for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning algorithm requiring a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.