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CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).

Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

The provided document is a 510(k) summary for a medical device called "Cornisol," a corneal storage solution. It discusses the device's characteristics, intended use, and comparison to a predicate device (Optisol-GS) to demonstrate substantial equivalence.

However, the document does not provide specific acceptance criteria or detailed results of a comparative effectiveness study with human readers. It focuses on the chemical, physical, and in-vitro performance of the solution itself, rather than an AI-assisted diagnostic device.

Therefore, many of your requested items, such as multi-reader multi-case studies, AI assistance, ground truth establishment for training/test sets, and sample sizes for AI model training/testing, are not applicable to this type of device (a corneal storage solution). The performance evaluation here is about the preservation efficacy of the solution, not the diagnostic accuracy of an AI algorithm.

Here's what can be extracted and inferred based on the provided text, and where information is missing:

Device Under Review: Cornisol (Corneal Storage Solution)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the in-vitro study results. The key performance characteristic is the ability to preserve human corneas for up to 14 days under refrigeration (2-8°C) for keratoplasty.

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

• Test Set Sample Size:
  • Study 1 (Prospective, in vitro, randomized): "paired donor corneas" - The exact number is not specified in the provided text.
  • Study 2 (Comparison with Optisol-GS): "donor corneas" - The exact number is not specified.
• Data Provenance: The studies were "in vitro," implying lab studies using donated human corneas. The country of origin for the donor corneas is not specified. It is retrospective in the sense that they are studying the effect on previously donated corneas, but the study design (e.g., "prospective, in vitro, randomized") refers to the execution of the experimental work.

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

This is not applicable as this is a biochemical/biophysical product evaluation, not an AI diagnostic device. Ground truth is established by objective measurements (e.g., endothelial cell counts, protein expression via immunostaining) on the preserved corneas, not by expert interpretation of images.

4. Adjudication Method for the Test Set

Not applicable for this type of product testing. The "ground truth" is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this type of study is for diagnostic AI devices involving human interpretation of medical images. Cornisol is a storage solution.

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

Not applicable. There is no AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation was based on objective biological and physical measurements from ex-vivo human corneas after storage. These included:

• Endothelial cell loss
• Endothelial cell density (ECD)
• Coefficient of variance of endothelial cells
• Percentage hexagonality of endothelial cells
• Immunostaining for markers of structural integrity (ZO-1, Phalloidin)
• Immunostaining for markers of functionality (Na+/K+ ATPase)

8. The Sample Size for the Training Set

Not applicable. There is no AI model being trained. The "training" for this product type involves R&D and formulation optimization, not data-driven machine learning.

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

Not applicable.

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Absorbable Surgical Suture USP/EP is indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of this suture in cardiovascular, neurological and micro surgery have not been established.

Not Found

Unfortunately, the provided document does not contain the specific information requested regarding "acceptance criteria and the study that proves the device meets the acceptance criteria." The document is a clearance letter from the FDA for a device called "Polycryl," an absorbable poly(glycolide/L-lactide) surgical suture.

While it mentions that the device is "substantially equivalent" to legally marketed predicate devices, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts for a test set.
• Information on adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Details about the training set size or how its ground truth was established.

The document is purely an FDA clearance letter confirming substantial equivalence under a 510(k) pathway, and therefore does not delve into the detailed study results or performance metrics associated with acceptance criteria that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

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Aurolab nonabsorbable Silk suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.

This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.

This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.

The provided document is a 510(k) summary for Aurolab's nonabsorbable Silk sutures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data as typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly mentioned. The document states that "tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture-needle attachment." USP monographs specify testing methods, which include sample sizes (e.g., 10 suture strands for specific tests), but the exact number of samples tested by Aurolab is not provided in this summary.
• Data Provenance: The tests were conducted internally by Aurolab in India. The data is retrospective in the sense that the summary is presenting results of tests already completed.

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

This is not applicable to the provided document. The "ground truth" for this medical device (nonabsorbable silk suture) is established by adherence to recognized industrial standards, specifically the United States Pharmacopoeia (USP). Experts in this context would be laboratory technicians and quality control personnel performing the physical and mechanical tests, not clinical experts establishing a medical "ground truth."

4. Adjudication Method

Not applicable. Performance is determined by objective measurements against predefined USP specifications, not by expert adjudication of clinical outcomes or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI/ML devices where human interpretation is involved. For a surgical suture, the effectiveness is demonstrated through mechanical and material property testing and clinical use experience (not detailed in this summary).

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This is a medical device (surgical suture), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on United States Pharmacopoeia (USP) standards and specifications for nonabsorbable silk sutures. These are objective, measurable physical and chemical properties.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary of Acceptance Criteria and Study Design for the Suture:

The study conducted to demonstrate the substantial equivalence of the Aurolab nonabsorbable Silk sutures was a bench testing study focused on characterizing the physical and mechanical properties of the suture.

• Acceptance Criteria: The primary acceptance criteria were that the device's diameter, tensile strength, and suture-needle attachment met the specifications outlined in the United States Pharmacopoeia (USP) for nonabsorbable silk sutures.
• Study Design:
  • Objective: To establish technical equivalency with predicate devices (Ethicon silk nonabsorbable sutures).
  • Methodology: Performance tests were conducted in accordance with USP methodologies.
  • Results: The tests performed showed that Aurolab devices meet USP standards and are technically equivalent to the predicate devices.
  • Conclusion: Based on these tests, the device was deemed substantially equivalent to legally marketed predicate devices.

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Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.

The provided text describes a 510(k) summary for a Nylon Suture manufactured by Aurolab. The study focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the performance results related to the device itself (the suture), even though it's not an AI device.

Here's the information based on the provided text, with clarifications where AI-specific details are not applicable:

Acceptance Criteria and Device Performance for Aurolab Nylon Suture

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the testing of diameter, tensile strength, and suture-needle attachment. It mentions that tests were conducted "according to methods presented in United States Pharmacopoeia (U.S.P)".

Data Provenance: Not explicitly stated beyond "tests according to methods presented in United States Pharmacopoeia (U.S.P)". The manufacturer is Aurolab, located in India. The studies were likely performed internally or by a contracted lab. The study appears to be a bench study to assess physical properties, not a clinical study on patient data.

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

Not applicable. This device is a physical medical device (suture), and its performance was assessed against established physical standards (USP) through laboratory testing, not through expert review of data.

4. Adjudication method for the test set

Not applicable. The assessment was based on objective measurements against USP standards, not subjective interpretation requiring adjudication.

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 device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The ground truth used was United States Pharmacopoeia (U.S.P) standards for physical properties of sutures, specifically:

• Diameter
• Tensile Strength
• Suture-Needle Attachment

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI/ML algorithm. The "ground truth" for the performance evaluation was established by the USP standards themselves.

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