(66 days)
The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.
A single use ophthalmic device designed to retract eye muscles.
The Stephens Disposable Hooks are Class I ophthalmic devices intended for single-use retraction of eye muscles in various ophthalmic procedures. The device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices, namely Katena Ophthalmic Hooks, Storz Ophthalmic Hooks, Rhein Ophthalmic Hooks, and previous Stephens Ophthalmic Hooks. The summary outlines performance tests conducted to prove this equivalence.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1.0 Dimensional Equivalency | Hook measurements were substantially equivalent to the predicate devices. |
| 2.0 Retraction Tension | The mechanism and holding ability performed as well as the predicate devices. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified in the provided text. The document only states that "the instrument's" measurements were compared and "the Stephens hooks" were tested, implying a single sample or a small, unspecified number used for performance evaluation against predicates.
- Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer. No indication of country of origin is given. The data would be considered retrospective in the sense that it's a comparison to existing devices.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The study did not involve establishing ground truth from expert consensus in a clinical setting. It was a physical performance and dimensional comparison.
4. Adjudication Method for Test Set
- Not applicable. This was not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No MRMC study was conducted as this device is a surgical instrument and not an AI or imaging diagnostic tool.
6. Standalone Algorithm Performance
- Not applicable. This device is a manual surgical instrument, not an algorithm or software.
7. Type of Ground Truth Used
- Dimensional measurements and performance characteristics (retraction tension) of legally marketed predicate devices. The ground truth for the "Dimensional Equivalency Test" was the measurements of the predicate devices. For the "Retraction Tension Tests," the ground truth was the performance of the predicate devices.
8. Sample Size for Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set was Established
- Not applicable. This device is not an AI/ML algorithm.
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.