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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."

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.

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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:

1. 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.

2. 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."

3. 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.

4. Adjudication method for the test set: Not applicable/not specified.

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 device is an IOL injection system, not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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.

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.

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