(77 days)
The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.
The AMO®PhacoFlex® II Insertion System is used to fold and assist in the insertion of an AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lens (IOL) into the eye following cataract extraction. The materials used in the AMO®PhacoFlex® II Insertion System are similar to the materials used in predicate devices. The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components: AMO®PhacoSert™ Handpiece (Model #PSH-ST), AMO®PhacoSert™ Soft Tip, Single-use soft tip holder, and AMO® PhacoSert™ Cartridge (Model #PSC-ST).
The provided 510(k) summary for the AMO®PhacoFlex® II Insertion System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. As a result, many of the requested elements for a detailed study description are not explicitly provided.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific numerical acceptance criteria for each variable are not explicitly stated in the document. Instead, the summary indicates that "All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance."
This implies that the acceptance criteria were likely qualitative (e.g., "no significant impact") or aligned with the performance of the predicate device.
| Variable Evaluated | Reported Device Performance | Acceptance Criteria (Implied) |
|---|---|---|
| Impact on IOL dioptric power | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance. | No significant impact on IOL optical performance (relative to predicate or baseline). |
| IOL resolution return/fold recovery | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance. | Acceptable fold recovery and resolution return (relative to predicate or baseline). |
| Overall lens diameter and haptic angle | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens dimensions. | No significant impact on overall lens diameter and haptic angle (relative to predicate or baseline). |
| IOL decentration, tilt and compression force testing | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens dimensions. | Acceptable levels of decentration, tilt, and compression force (relative to predicate or baseline). |
| IOL haptic pull strength | Not explicitly detailed beyond general statement. | Acceptable haptic pull strength (relative to predicate or baseline). |
| Force required to advance the IOL | Not explicitly detailed beyond general statement. | Acceptable force required for IOL advancement (relative to predicate or baseline). |
| IOL release characteristics | Not explicitly detailed beyond general statement. | Reliable IOL release (relative to predicate or baseline). |
| Streaks on IOL | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting cosmetic appearance. | No significant streaks on the IOL (relative to predicate or baseline). |
| IOL optic body marks/damage | Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting cosmetic appearance. | No significant optic body marks/damage on the IOL (relative to predicate or baseline). |
| Biocompatibility (Cytotoxicity, Ocular Irritation, Sensitization) | Materials are non-toxic, non-irritating, non-inhibitory, and non-sensitizing. (Specific to soft tip and soft tip holder; cartridge biocompatibility established for predicate). | Materials pass specified ISO/USP biocompatibility tests (non-toxic, non-irritating, non-inhibitory, non-sensitizing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the in vitro performance testing. The term "all test results" implies multiple instances, but a numerical count is absent.
- Data Provenance: The testing was "in vitro performance testing," meaning it was conducted in a laboratory setting, not on human subjects. There is no mention of country of origin or whether it was retrospective or prospective in the context of human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable or not specified. In vitro performance testing typically relies on standardized measurement techniques and instruments, not expert human assessment to establish "ground truth" in the clinical sense.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was in vitro performance testing, there's no mention of human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is used for evaluating human reader performance, often with AI assistance, and is not relevant for in vitro device performance testing of an IOL insertion system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in a sense. The in vitro performance testing describes the standalone performance of the device (the AMO®PhacoFlex® II Insertion System) in delivering IOLs, entirely independent of human interaction beyond operating the system according to its design. There is no "algorithm" in the sense of AI; it's a mechanical device.
7. Type of Ground Truth Used
- For the in vitro performance tests (e.g., IOL dioptric power, dimensions, marks): The "ground truth" would be established by objective measurements using calibrated laboratory equipment and standard test methods (e.g., refractometers, microscopes, micrometers, force gauges).
- For the biocompatibility tests: The "ground truth" was established by the results of standardized biological assays (e.g., ISO Agarose Overlay Method, ISO Elution Method, USP Agar Diffusion, Ocular Irritation Study, Delayed Contact Sensitization Study).
8. Sample Size for the Training Set
- Sample Size: Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and materials are based on engineering principles and predicate device characteristics, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. There is no training set or ground truth in the context of AI. The "truth" for the device's development lies in engineering specifications, material properties, and performance validation against those specifications, often informed by predicate device performance.
§ 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.