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510(k) Data Aggregation
(64 days)
HNQ
An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.
Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configuration so as to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The instrument has an acrylic handle and one needle at each end. Each end is uniquely designed to create a right-hand end and a left-hand end to aid the surgeon during the procedure.
The provided text describes a 510(k) premarket notification for the OPHTEC Enclavation Needle. It establishes substantial equivalence to a predicate device but does not contain information about acceptance criteria, a study proving device performance, or details regarding a test set, ground truth establishment, or sample sizes related to performance studies.
The document is primarily focused on the regulatory approval process (510(k)) and establishing substantial equivalence, rather than detailing clinical or performance study results. As such, I cannot extract the requested information from the provided text.
Based on the information given, the device is classified as an ophthalmic hook and is described as a surgical stainless steel needle designed to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The 510(k) process typically relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. This often involves comparing design specifications, materials, and intended use, rather than conducting new performance studies that would require the detailed information you've requested.
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(66 days)
HNQ
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.
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