(136 days)
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge (LC-16 w/ Silicone Cushion (SIC-01-02) or LC-24 w/ Silicone Cushion (SIC-01-02)) and Injector (I-9011). One type of injector is provided: it is syringe based and is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.
The provided document, K063802, does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for software or AI/ML-based medical devices.
This device, the Lenstec LC Injection System, is an intraocular lens (IOL) guide and injector system. The submission focuses on demonstrating substantial equivalence to existing predicate devices, a common pathway for Class I and II medical devices that do not involve complex software or AI.
Here's an analysis based on the document, addressing the prompt's questions where applicable, and noting where information is not present due to the nature of the device and submission:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or error rates for an AI system). Instead, its "performance data" section is very brief and focuses on:
- Biocompatibility: "All contact materials have been tested for biocompatibility." This implies meeting regulatory standards for material safety.
- System Functionality: "The system was tested with STAAR Collamer Intraocular Lens model CC4204BF." This broadly suggests it was confirmed to function with its intended IOL, likely encompassing aspects like smooth delivery and lack of damage to the IOL.
Given the device type (an injector system), acceptance criteria would likely revolve around mechanical integrity, successful IOL delivery without damage, and material biocompatibility. These are implicitly assumed to be met for substantial equivalence, but explicit metrics are not provided.
| Acceptance Criteria (Inferred from device type) | Reported Device Performance |
|---|---|
| Materials are biocompatible. | All contact materials have been tested for biocompatibility. |
| System functions with intended IOL (STAAR Collamer Intraocular Lens model CC4204BF). | The system was tested with STAAR Collamer Intraocular Lens model CC4204BF. |
| IOL is successfully implanted without damage. | (Implicitly assumed through testing with IOL) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "The system was tested with STAAR Collamer Intraocular Lens model CC4204BF." There is no mention of a specific number of tests or samples.
- Data Provenance: Not specified. Given the lack of clinical trials, the testing would likely have been bench testing or preclinical, presumably conducted by the manufacturer, Lenstec Inc., based in St. Petersburg, FL, USA.
- Retrospective or Prospective: Not applicable. The testing described is non-clinical/bench testing, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is an injector system, not a diagnostic or AI device that requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Performance would be assessed through objective measurements during bench testing (e.g., successful ejection, force required, IOL integrity).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication process described or required for this type of device's performance evaluation.
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 is not an AI/ML device or a diagnostic device that involves human readers or interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "testing" mentioned, the ground truth would likely be objective physical criteria (e.g., visual inspection of IOL for damage, measurement of injection force, successful deployment, material analysis for biocompatibility). These are fundamental engineering and biocompatibility benchmarks, not clinical ground truth in the sense of disease diagnosis or prognosis.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary regarding the device and approval:
The K063802 submission for the Lenstec LC Injection System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically:
- Lenstec Injection System for Tetraflex Intraocular lenses (K050638)
- Lenstec Injection System for Softec Injection System (K060533)
The "study that proves the device meets the acceptance criteria" is implicitly the set of non-clinical tests mentioned (biocompatibility, system testing with the specific IOL). For this class and type of device, substantial equivalence often relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness compared to the predicate. The FDA concluded that clinical tests were "Not required" for this submission, indicating that the non-clinical data and comparison to predicates were deemed sufficient to establish substantial equivalence.
§ 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.