(168 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 a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.
The NLT SPINE eSpin device is a medical device intended for discectomy procedures. The provided text, K120553, is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel acceptance criteria and proving performance against them through a detailed study like one would for a new technology or higher-risk device.
Therefore, the supplied text does not contain specific acceptance criteria, detailed performance metrics (like sensitivity, specificity, accuracy), or a study design for proving these metrics. It describes the device, its intended use, and states that performance testing in bench and cadaver models demonstrated substantial equivalence to the predicate device.
However, based on the information provided, here's an attempt to structure an answer, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" and quantitative performance metrics (e.g., sensitivity, specificity, or specific success rates) are not provided in the document for the eSpin device itself. The primary acceptance criterion for a 510(k) is demonstrating that the new device is "as safe and effective" and "substantially equivalent" to a predicate device.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (from K120553) |
|---|---|
| Safety and Effectiveness equivalent to predicate device | Demonstrated through bench and cadaver models. "eSpin is as safe and effective as its predicate device." |
| Similar Indications for Use | "The eSpin has substantially similar indications for use... as compared to the predicate device." |
| Similar Technological Characteristics | "The eSpin has... substantially similar... technological characteristics as compared to the predicate device." |
| No New Questions of Safety and Effectiveness | "Any minor differences between the device and the predicate do not raise new questions of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
The document states "Performance testing in bench and cadaver models".
- Sample Size: Not specified. The number of bench tests or cadaver models used is not reported.
- Data Provenance: The location of the testing (e.g., country of origin) is not specified. It is likely conducted by the manufacturer, NLT SPINE Ltd. in Kfar-Saba, Israel, or a contract lab. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing described (bench and cadaver models) would not typically involve expert radiologists or similar for "ground truth" establishment in the context of diagnostic or interpretive accuracy. Instead, it would involve direct measurement of physical properties, material analysis, mechanical testing, and functional assessment.
4. Adjudication method for the test set
Not applicable. The type of performance testing (bench and cadaver models) does not involve adjudication methods like 2+1 or 3+1, which are typically used for assessing agreement among human reviewers in diagnostic studies.
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
Not applicable. The eSpin device is a surgical instrument (arthroscope and accessories for discectomy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The eSpin is a physical surgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "bench and cadaver models," the ground truth would be based on:
- Bench Testing: Engineering specifications, material properties, mechanical test standards, and direct measurements of cutting/grinding efficacy and safety parameters (e.g., material removal rate, damage to surrounding tissue, tip integrity).
- Cadaver Models: Direct observation and assessment of the device's ability to cut and grind intervertebral disc material as intended, without damaging adjacent structures, and evaluating its handling characteristics in a simulated surgical environment. This is typically assessed by surgeons or technical experts.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.
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.