(66 days)
Scissors made for single use in the cutting of tissue in various ophthalmic procedures.
A single use ophthalmic device designed for cutting tissues.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Stephens Disposable Scissors:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | "The blade measurements of the scissors were substantially equivalent to the measurements of the predicate devices listed above." |
| Sharpness - Number of Cuts | "It was found that Stephens scissors perform as well as the predicate devices." |
| Sharpness - Initial Cutting Sharpness | "It was found that Stephens scissors perform as well as the predicate devices." |
Explanation of Criteria:
- Dimensional Equivalency: This implies that the critical dimensions (like blade length, width, angle) of the Stephens Disposable Scissors had to be sufficiently close to those of the predicate devices to ensure similar function and safety.
- Sharpness (Number of Cuts & Initial Cutting Sharpness): The device needed to demonstrate comparable cutting ability to the predicate devices, both in terms of how many cuts it could perform effectively and its initial sharpness. This is crucial for an ophthalmic scissor to ensure precise and efficient tissue cutting.
2. Sample Size and Data Provenance for Test Set:
- Sample Size: The document does not specify the exact sample size used for the Dimensional Equivalency Test or the Sharpness Tests. It only states that the tests were "performed."
- Data Provenance: The documents do not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of performance bench testing, it would inherently be prospective, but the location is unknown.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable. These tests are objective bench tests, not involving expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set:
- Adjudication Method: Not applicable. These were objective physical performance tests, not requiring human adjudication of results in the traditional sense of clinical imaging or diagnostic studies. The results would be quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable, as no such study was conducted. This device is a surgical instrument and its performance is evaluated by physical characteristics rather than diagnostic accuracy involving human readers.
6. Standalone Performance Study:
- Standalone Performance Study: Yes, standalone performance tests were conducted. The "Dimensional Equivalency Test" and "Sharpness Tests" (both number of cuts and initial cutting sharpness) evaluate the device's inherent physical characteristics and performance independently. There is no human-in-the-loop component for these specific tests.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for these performance tests was based on objective physical measurements and comparisons to predicate devices. For dimensional equivalency, it would be measured dimensions against predicate device specifications. For sharpness, it would be quantitative sharpness metrics (e.g., force required to cut, number of cuts on a standardized material) compared to the performance of predicate devices.
8. Sample Size for Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a physical surgical instrument.
9. How Ground Truth for Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
§ 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.