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The Lenstec IOL Injection System is intended for use in implantation of the Lenstec Softec Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

The system consists of the following components: Cartridge LC604220 used with Injector I 9000 for Nominal Incision Size (mm) 2.8 and Used with Softec Intraocular Lenses Power Range (D) 26.5D to 42.0D; Cartridge LC604240 W/LS604500 used with Injector I 9007 for Nominal Incision Size (mm) 2.2 and Used with Softec Intraocular Lenses Power Range (D) -5.0D to 26.0D. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.

The provided document is a 510(k) summary for the Lenstec Injector System for Softec Intraocular Lenses. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria related to its performance metrics as an AI/ML powered medical device.

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for certain medical devices in the US. The "performance data" section explicitly states "Non-clinical tests: All contact materials have been tested for biocompatibility. The system was tested with Softec intraocular lenses." and "Clinical tests: Not required."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to a physical medical device (an injector system for intraocular lenses) and its regulatory clearance based on substantial equivalence, not an AI/ML powered medical device with performance metrics related to diagnostic accuracy, sensitivity, specificity, etc. The "performance data" refers to biocompatibility and physical compatibility with the lenses, not algorithmic performance.

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The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

The system consists of the following components: Cartridge, Injector. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.

The Lenstec Injector System for Tetraflex™ Intraocular Lenses (K050638) is a Class I medical device, and as such, clinical tests were not required for its premarket notification. The device's approval was based on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and shared technological characteristics.

Therefore, the following information, typically found in a clinical study report proving device performance against acceptance criteria, is not available or applicable for this submission:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone (algorithm only) performance study results
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How the ground truth for the training set was established

Instead, the submission focused on non-clinical aspects and established substantial equivalence based on:

• Technological Characteristics: The device consists of a reusable titanium injector and single-use polypropylene cartridges. The submission details the nominal incision sizes and power ranges of the Tetraflex™ intraocular lenses used with the system.
• Biocompatibility: All contact materials were tested for biocompatibility.
• System Testing: The Lenstec Injector System was tested with Tetraflex™ intraocular lenses to ensure compatibility and functionality.
• Comparison to Predicate Devices: The Lenstec Injector System was deemed substantially equivalent to the Medicel MultiJect Injector for IOLs and MicroGlide Cartridge (K040837) and the STAAR Surgical Foam Tip™ Injector System (K980696) in terms of safety and efficacy.

In summary, for K050638:

• Acceptance Criteria & Device Performance: Not explicitly detailed as clinical performance metrics. The implicit acceptance criteria were that the device performs its intended function (inserting IOLs) safely and effectively, as demonstrated through non-clinical testing and comparison to predicate devices.
• Study Type: Non-clinical tests, primarily biocompatibility and functional testing with the intended IOLs.
• Clinical Studies: "Not required" as explicitly stated in the submission.

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