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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."

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The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

• An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 – 220 µm of thickness into the anterior chamber of the eye during endothelial keratoplasty.
• For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm)
• For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

The Endothelial Keratoplasty Injector is a single-use, disposable device that allows an ophthalmic surgeon to insert a previously prepared disc of posterior donor cornea into the eye of a recipient patient through a small incision during a posterior comeal transplant surgical procedure. The function of the device is to insert the flat disc of donor comeal tissue within a cylindrical tube that is sized to fit into 5.1 mm or larger corneal or scleral incision, and to pull or push this donor corneal tissue into the anterior chamber of the eye as part of a Endothelial Keratoplasty procedure. This device was designed to insert donor posterior corneal tissue ≤ 8.5 mm in diameter, 100um to 220um in thickness, through a 5.1 mm or larger corneal incision.

The EK Delivery device consists of four components: (1) the Trocar which is used to hold the graft material and introduce it into the anterior chamber of the recipient eye, (2) the Trocar Holder, which is used to close the proximal end of the Trocar and as an ergonomic handle to aid the surgeon handling the device, (3) the Injector Assembly, which is a plunger to push the endothelial keratoplasty tissue out of the Trocar and into the anterior chamber of the recipient eye, and (4) End Plug used during shipping. Delivers a circular endothelial tissue button in a rolled configuration.

Here's an analysis of the provided 510(k) summary for the TDAK Medical, Inc. EK Delivery Device, focusing on acceptance criteria and study details:

Device: TDAK Medical, Inc. EK Delivery Device

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary is for a Class I (reserved) medical device, specifically an Endothelial Keratoplasty (EK) Injector. For such devices, the "acceptance criteria" are primarily related to meeting performance specifications and demonstrating substantial equivalence to a predicate device, rather than statistical performance metrics (like sensitivity/specificity) typically seen in diagnostic AI/ML devices.

The acceptance criteria are inferred from the comparison table and the description of testing performed to demonstrate equivalence and safety.

Study Information

The document describes pre-market testing to demonstrate substantial equivalence to a predicate device (EndoSerter™ K090626), rather than a clinical efficacy study with human subjects. The studies are primarily engineering and bench-top tests.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test (e.g., how many devices were tested for mechanical strength, or how many tissue samples for tissue handling). These would typically be detailed in the full test reports, which are not part of this summary document.
   • Data Provenance: The studies were conducted by TDAK Medical, Inc. The nature of the device (a delivery tool) means the "data" is primarily performance data from pre-clinical, bench-top testing, not clinical data from patients or tissue banks in a specific country. The studies are retrospective in the sense that they are validations conducted before market entry.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this device. The "ground truth" for a mechanical device like this is whether it performs its intended function (e.g., inserts tissue without damage, maintains sterility, has adequate mechanical strength). This is established through engineering specifications, material science, and performance testing, not through expert human interpretation or diagnosis. No "test set" in the diagnostic sense is described that would require expert ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are used in studies involving human interpretation or clinical endpoints (e.g., a panel of radiologists reviewing images). This is a device for physical delivery of tissue.

4. 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, nor is it a diagnostic device that involves human readers interpreting cases. It is a surgical delivery tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is based on established engineering principles, material standards, and functional testing against design specifications. For example:
     • Mechanical Strength: Demonstrated by testing to failure or against defined load limits.
     • Tissue Handling: Demonstrated by successful insertion of donor tissue surrogates or actual tissue samples without damage, and maintenance of tissue viability (implied by "Tissue Handling and Stability" testing and 72-hour storage claim).
     • Biocompatibility: Established through standardized in vitro and/or in vivo tests to ensure the device materials do not cause adverse biological reactions.
     • Sterilization: Validated using methods like "Sterilization Validation" to ensure a certain sterility assurance level (SAL).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable.

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