(153 days)
Lenstec's LC Injection System is intended for use in the implantation of the Softec I, Softec HDO, Softec HDM and any approved IOL in which labeling specifies use of this injector (s) to insert the capsular bag following extracapsular extraction.
The proposed system consists of the following components: Cartridge with silicone cushion, IOL, and Injector. Three types of injectors are provided: they are syringe based and reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion are single-use and are provided sterile.
The provided document is a 510(k) premarket notification for a medical device (Lenstec LC Injection System) and does not contain the detailed information required to fill out the table regarding acceptance criteria and device performance as it would be presented in a study report. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical or non-clinical study report with detailed acceptance criteria, sample sizes, and expert evaluations.
However, I can extract the relevant information that is present in the document to address some of your points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions non-clinical tests but does not define specific quantitative acceptance criteria or provide detailed performance metrics in a tabular format. The general statement is that tests were "satisfactory."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility tests | Satisfactory results |
| System performance with Lenstec IOL models (Softec HD, Softec HDO, Softec HDM, Softec I) | Satisfactory results |
| Particulate Matter in Ophthalmic Solutions (USP ) | Cartridges tested passed the USP Light Obscuration Tests |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-clinical): The document does not specify exact sample sizes for the non-clinical tests performed on the cartridges or with the IOL models. It refers to "the system was tested with each of the following Lenstec intraocular lens models" and "the cartridges tested."
- Data Provenance: Not specified, but standard for device manufacturers to conduct these tests in-house or through certified labs. This would be considered non-clinical, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is a submission for a medical device (intraocular lens injection system), not an AI or diagnostic device that requires expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological performance of the device components, validated by standard engineering and biocompatibility testing.
4. Adjudication Method for the Test Set:
Not applicable as it's not a study involving human interpretation or clinical adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a submission for an ophthalmic medical device, not an AI or diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
No. This document pertains to a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- For biocompatibility: Established biological safety standards and test methodologies.
- For system performance with IOLs: Successful delivery of the IOL without damage or complications, likely assessed visually and functionally. The term "satisfactory results" implies meeting predefined engineering and functional specifications.
- For particulate matter: USP standards.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable.
Summary of what the document implies about the study (non-clinical):
The document describes non-clinical testing conducted to support the substantial equivalence claim for the Lenstec LC Injection System. This testing focused on:
- Biocompatibility: Ensuring safety of contact materials.
- Performance with IOLs: Verifying the system can implant various Lenstec IOL models (Softec HD, Softec HDO, Softec HDM, Softec I) satisfactorily.
- Particulate Matter: Ensuring cartridges meet USP standards for ophthalmic solutions.
The basis for equivalence extends to changes in cartridge models, introduction of LubriMATRIX™ surface treatment, and a minor material change in polypropylene, with tests confirming these changes do not negatively impact device performance or safety. No clinical studies were required for this 510(k) submission.
§ 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.