Search Results

The EndoSerter® PL is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.0 mm in diameter and 100 microns in central thickness into the anterior chamber through a minimum 4.0 mm incision during endothelial keratoplasty procedures and for loading and storage of donor transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 48 hours.

The EndoSerter®-PL is a sterile, single use, handheld, manual ophthalmic surgical instrument. It is used to preload a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon is performed by trained technician at the eye bank.

This device, the EndoSerter®-PL, is a medical instrument used for inserting corneal endothelial allograft tissue. The provided document is a 510(k) Premarket Notification from the FDA, which determines substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than meeting specific performance metrics with associated thresholds. The "study" refers to the pre-clinical performance data provided to support this claim of substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a PMA or de novo submission requiring clinical trials with specific endpoints, the "acceptance criteria" are implied by the aspects of safety and effectiveness that need to be comparable to predicate devices. The performance data provided addresses these aspects.

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

The document describes pre-clinical engineering and biological testing. It does not mention a test set in the context of patient data or clinical performance. The "samples" would relate to the number of devices or tissue samples used in each specific test:

• Biocompatibility: Not specified, but typically involves multiple samples of each material or component tested.
• Tissue Handling and Stability Testing: Not explicitly stated, but implies a number of donor allograft tissues were loaded, stored, transported, and delivered. The exact count is not provided.
• Sterilization Validation: Not specified, but validation studies involve multiple sterility tests.
• Shelf Life and Transportation Testing: Not specified, but multiple devices would be subjected to leak tests, accelerated aging, etc.
• Aseptic Handling Testing: Not specified, but multiple samples would be tested to demonstrate the process's ability to prevent contamination.
• Dimensional, Functional, and Mechanical Testing: Not specified, but typically involves a representative sample size of manufactured devices.

Data Provenance: All data appears to be pre-clinical laboratory testing conducted by or on behalf of CorneaGen, Inc. There is no indication of country of origin for test data in the provided text, nor is there information about retrospective or prospective patient data, as no human clinical trials are described.

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

This question is not applicable to this 510(k) submission.

• There is no "test set" in the context of patient data requiring expert ground truth establishment.
• The studies described are pre-clinical performance evaluations (e.g., biocompatibility, mechanical testing) where "ground truth" is established through standardized test methods (e.g., ISO 10993-1, USP ).
• The tissue handling and stability study quantitatively determined endothelial cell damage, likely using a laboratory method rather than expert consensus on images.

4. Adjudication Method for the Test Set

This question is not applicable as there is no "test set" from patient data and no human interpretation to adjudicate.

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

This question is not applicable. The EndoSerter®-PL is a manual surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The EndoSerter®-PL is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

As this is a pre-clinical performance evaluation of a medical device, the "ground truth" for the studies described would be:

• Standardized Test Methods and Scientific Principles: For biocompatibility (ISO 10993-1), sterility (SAL 10^-6), shelf life, and mechanical testing, the "ground truth" is defined by the requirements of the specific international standards and validated test procedures used.
• Quantitative Measurements: For tissue handling, the "ground truth" for damage would be based on quantitative measurements of endothelial cell loss through established laboratory techniques (e.g., cell counting, viability assays).
• Absence of Contamination: For aseptic handling, the "ground truth" for success is the absence of microbial contamination as determined by microbiological testing.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The studies described are pre-clinical performance validations.

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

This question is not applicable as there is no "training set."

Ask a specific question about this device