(395 days)
The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge with silicone cushion, IOL, Injector. One type of injector is provided: it is syringe based and is reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile. The system has three major components: a reusable injector, a reusable lens loader and one of three disposable cartridges (LC 16, LC 1620, LC 2420) with a silicone cushion (SIC-01-02). a. the injector is manufactured of titanium and can be autoclaved. b. the lens loader is manufactured from plastic and can be autoclaved. c. the cartridge is manufactured of medical grade polypropylene and is for single use. d. the silicone tip is manufactured of medical grade silicone and is for single use.
The provided text describes the Lenstec LC Injection System, an intraocular lens injection system. However, it does not contain specific acceptance criteria or a study that quantitatively proves the device meets such criteria with detailed metrics like sensitivity, specificity, or accuracy.
The document generally outlines the device's design, intended use, and substantial equivalence to a predicate device. It mentions "non clinical tests" for biocompatibility and satisfactory testing with specific IOL models, but it does not provide details on the acceptance criteria for "satisfactory" or the performance results.
Therefore, many of the requested items cannot be extracted from the provided text.
Here's what can be extracted based on the given text:
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Table of acceptance criteria and reported device performance:
Acceptance Criteria Reported Device Performance Biocompatibility Satisfactory results Compatibility with Softec HD IOL Satisfactory results Compatibility with Softec I IOL Satisfactory results Compatibility with Softec HD PS IOL Satisfactory results Note: The document uses "satisfactory results" without defining specific quantitative acceptance criteria or performance metrics.
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Sample size used for the test set and the data provenance: Not specified in the document. The text only mentions "All contact materials have been tested for biocompatibility" and "the system was tested with each of the following Lenstec intraocular lens models."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The testing described appears to be technical performance and biocompatibility testing, not expert-adjudicated clinical data.
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Adjudication method for the test set: Not applicable/not specified.
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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 injection system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used: For biocompatibility, it would typically be established by standardized laboratory tests (e.g., ISO 10993 series). For IOL compatibility, it would likely be successful injection and proper IOL handling without damage or complications during the process. The document does not specify further details.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.