(66 days)
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
A single use ophthalmic device designed to manipulate eye tissues or muscles.
The provided text describes a 510(k) premarket notification for the Stephens Disposable Forceps, a Class I ophthalmic device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a complex AI-driven system. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | The teeth measurements of the forceps were substantially equivalent to the measurements of the predicate devices. |
| Manipulation (Mechanism & Holding Ability) | The mechanism and holding ability of the Stephens forceps were found to perform as well as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or data analysis. The performance tests ("Dimensional Equivalency Test" and "Manipulation Tests") likely involved a sample of the manufactured forceps.
- Data Provenance: Not applicable in the traditional sense of patient data. The tests were likely conducted in a laboratory setting on prototypes or production samples of the device and predicate devices. No country of origin for specific "data" is mentioned other than the company's location (Lexington, KY, USA). The studies are not considered "retrospective" or "prospective" as they are performance tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance tests described (dimensional and manipulation) would be assessed against engineering specifications or by direct comparison to the physical characteristics and function of the predicate devices, not by expert clinical consensus for "ground truth."
4. Adjudication method for the test set
Not applicable. There's no mention of a formal adjudication process for interpreting test results, as these are objective engineering and performance comparisons.
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. This device is a physical ophthalmic forceps, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For dimensional equivalency, the ground truth would be the measurements of the predicate devices' teeth. For manipulation tests, the ground truth would be the observed performance (mechanism and holding ability) of the predicate devices. Neither is "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
§ 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.