(58 days)
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RxSight Insertion Device:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly list "acceptance criteria" with specific pass/fail thresholds. Instead, it describes the types of performance tests conducted and states that the device "meets all product design requirements and applicable standards."
Based on the summary, we can infer the following performance evaluations:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Evaluated and deemed adequate. |
| Sterilization (Cartridge) | Validated in accordance with ANSI/AAMI/ISO 11135 to ensure a sterilization assurance level (SAL) of 10-6. |
| Sterilization (Handpiece) | Validated via Autoclave cleaning/sterilization cycle in accordance with "Reprocessing Medical Devices..." guidance. |
| Cleaning (Handpiece) | Validated for both manual and automated processes as described in labeling. |
| Sterilization Residuals | Evaluated and deemed adequate. |
| Shipping and Handling | Evaluated and deemed adequate. |
| Mechanical Dimensions of IOL (Post-injection) | Verified after lens delivery and compared to pre-delivery measurements (per ISO 11979-3:2012). Implicitly meets standards. |
| Sagitta of IOL (Post-injection) | Verified after lens delivery and compared to pre-delivery measurements (per ISO 11979-3:2012). Implicitly meets standards. |
| Optical Properties (Overall Surface & Bulk Homogeneity of IOL - Pre/Post-injection) | Tested pre and post lens injection (per ISO 11979-2:2014). Implicitly meets standards. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "two IOLs" for the pre- and post-injection evaluation of mechanical and optical properties. This is an extremely small sample size for a performance test. It does not provide sample sizes for other tests like biocompatibility or sterilization.
- Data Provenance: Not explicitly stated. These appear to be bench tests conducted by the manufacturer, but the location or specific context (e.g., in vivo, ex vivo, in vitro) is not detailed. There is no information about retrospective or prospective data collection from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are bench tests involving mechanical and optical measurements against ISO standards. There is no mention of expert-established ground truth or human readers involved in these performance tests.
4. Adjudication method for the test set
Not applicable. There is no mention of clinical endpoints or the need for adjudication as the tests are objective bench measurements.
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 an IOL insertion device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm. Its performance is evaluated through its physical function and interaction with the IOL, not through an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests appears to be defined by international standards (ISO 11979-2:2014, ISO 11979-3:2012, ANSI/AAMI/ISO 11135). The device's performance (e.g., maintaining IOL dimensions, sagitta, optical properties) is compared against requirements or expected values specified by these standards for pre- and post-injection conditions.
8. The sample size for the training set
Not applicable. This device is a mechanical instrument and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.