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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 Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells

The Fluid Isolation Device (FID) is a medical device which is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. The system consists of the following components: Vacuum ring suction cup connected to lure lock with silicone tubing, 20 mL Vaclok Syringe. Following cataract extraction, the device's vacuum ring suction cup is placed onto the posterior surface of the anterior capsule, and a seal is created by the user drawing back the handle of the Vaclok Syringe. Once the seal is created, the user irrigates the capsule of residual cortex and/or epithelial cells. The device is provided sterile (ethylene oxide).

Here's an analysis of the provided text regarding the Lenstec Fluid Isolation Device (FID) and its acceptance criteria, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in the context of clinical or in-vivo testing. The performance data presented are from non-clinical bench testing for functional suction power and biocompatibility.

Data Provenance: The studies were non-clinical (bench tests) and were performed by Lenstec Inc. No country of origin for a clinical test set is relevant here, nor is it retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The performance testing was non-clinical (biocompatibility and functional suction power). "Ground truth" in the sense of expert clinical diagnosis or interpretation is not relevant for these types of tests.

4. Adjudication Method for the Test Set

Not applicable, as the tests were non-clinical bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical tests: Not required." Therefore, no MRMC study comparing human readers with or without AI assistance was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Fluid Isolation Device (FID) is a medical device, not an AI algorithm. Its performance is directly dependent on user interaction (ophthalmic surgeon drawing back the syringe plunger to create suction).

7. The Type of Ground Truth Used

For the non-clinical tests:

• Biocompatibility: Likely based on standardized assays and comparison to established biological safety limits for medical device materials.
• Functional Suction Power over Time: Likely based on objective measurements of pressure/vacuum and seal integrity, with "ground truth" being the measurements themselves and the comparison to the predicate device's measured performance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device is not an AI algorithm.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Lenstec Fluid Isolation Device (FID) was determined to be substantially equivalent to its predicate device, the Milvella Perfect Capsule (K030957), based on non-clinical performance data.

The studies conducted were:

• Biocompatibility Testing: All contact materials were tested, and the results were deemed "satisfactory" and "equivalent to the predicate device" (Section 16 of the submission). This addresses the biological safety of the materials used in the device.
• Functional Suction Power over Time Testing (Bench Test): A "side-by-side comparison" of the FID's functional suction power over time was performed against the predicate device. All results were found to be "satisfactory" and "equivalent to the predicate device" (Section 19 of the submission). This test aimed to demonstrate that the FID could achieve and maintain the necessary seal and suction performance comparable to the legally marketed predicate.

No clinical studies were required or performed for this 510(k) submission, as the device's technological characteristics and intended use were considered substantially equivalent to a predicate device already on the market. The equivalence was established through material testing and bench performance comparisons.

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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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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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