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The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA.

The device consists of the following main components and accessories: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly, a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator,

Here's a breakdown of the acceptance criteria and the study information for the CIBA Centurion SES™ Epikeratome, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive details of clinical trials with detailed statistical analysis and performance metrics in the way one might expect for a novel device requiring a PMA. Therefore, some of the requested information (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies with effect sizes) is not present in this document. The "study" described is primarily a bench testing equivalence study.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample size: Not explicitly stated. The "test set" here refers to the components and overall device undergoing bench testing. It's likely involved multiple units/components, but a specific number is not provided.
   • Data provenance: Bench testing results. Location of testing not specified, but the applicant (CIBA Vision Corporation) is based in Duluth, Georgia, USA. The study is retrospective in the sense that it's a comparison to an existing, cleared device (K031735).

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

   • Not applicable as this was primarily bench testing for functional equivalence, not a clinical study requiring expert diagnosis or assessment for ground truth. Device function was likely assessed against engineering specifications and pre-defined performance metrics through testing.

3. Adjudication method for the test set:

   • Not applicable. As noted above, this was a bench testing comparison, not a clinical trial with case adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (keratome) and does not involve "human readers" interpreting images or data where AI assistance would be relevant in the context of diagnostic improvement.

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

   • Not applicable. This device is a physical surgical instrument, not an algorithm. The "functional and electrical safety test results" can be considered a standalone performance assessment of the instrument.

6. The type of ground truth used:

   • For the bench testing, the "ground truth" was likely the technical specifications and established performance characteristics of the predicate device (Centurion SES Epikeratome cleared under K031735), along with engineering design specifications and safety standards for medical devices. The device's ability to "remove epithelium in a consistent and reproducible way" would be assessed against these engineering and functional standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable for the same reason as above.

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The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: the control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.

The provided 510(k) summary for the CIBA Centurion SES Epikeratome describes a medical device, but it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to predicate devices, supported by bench testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies. This information is typically found in more comprehensive clinical study reports, which are not part of this 510(k) summary.

However, based on the provided text, I can infer and state what was used to establish equivalence:

Acceptance Criteria and Study Summary (Based on Substantial Equivalence and Bench Testing):

Detailed Study Information (Based on provided 510(k) Summary):

1. A table of acceptance criteria and the reported device performance: See table above. These are inferred from the 510(k)'s focus on substantial equivalence and bench testing, rather than explicit numerical acceptance criteria.

2. Sample sized used for the test set and the data provenance: Not specified. The document refers to "bench testing" but does not provide details on sample sizes, specific test protocols, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for showing equivalence was based on functional performance in bench testing relative to predicate devices, not on expert consensus from human data.

4. Adjudication method for the test set: Not applicable. No human adjudication process is described for performance evaluation; the assessment was based on bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an AC-powered surgical tool, not an algorithm. Its standalone performance was assessed through "functional and electrical" bench testing to demonstrate consistent and reproducible epithelium removal, and equivalence to predicate devices.

7. The type of ground truth used: The "ground truth" for demonstrating the device's performance was the established functionality and performance of the predicate devices, against which the Centurion SES Epikeratome was quantitatively and qualitatively compared via bench testing. The biocompatibility of materials was also a "ground truth" based on historical use.

8. The sample size for the training set: Not applicable. This device is a mechanical surgical tool, not an AI or algorithm that requires a training set.

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

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The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.

Not Found

The provided text does not contain detailed information about specific acceptance criteria, device performance, or a study design in the way that would typically be presented for a modern AI-powered medical device submission. This document is a 510(k) summary for the ASMOTOM Automated Trephine System, approved in 2001, which is a physical medical device (a trephine), not an AI-powered diagnostic system.

Therefore, many of the requested categories for AI-specific performance evaluation cannot be extracted from this document, such as:

• Sample size for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

However, based on the information available, I can provide a response focusing on what can be inferred or directly stated from the document, particularly regarding the device's intended use and the comparison to a predicate device.

Acceptance Criteria and Study for ASMOTOM Automated Trephine System (K013151)

The provided K013151 document is a 510(k) Summary for a physical medical device, the ASMOTOM Automated Trephine System, and therefore does not include the detailed performance study information typically required for AI-powered diagnostic devices. The acceptance criteria for such a device at the time would primarily revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness, often through bench testing and mechanical comparisons rather than extensive clinical studies with human interpretion.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance metrics as would be seen for an AI device. Instead, the substantial equivalence hinges on functional similarity and material comparison to the predicate device. The implicit acceptance criterion is that the device performs its intended function (performing penetrating cuts of the cornea for transplantation) in a manner similar to the predicate device, without raising different questions of safety or effectiveness.

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. For a device like a trephine, testing would typically involve bench testing (e.g., precision of cuts on artificial materials) rather than human patient data sets for diagnostic accuracy. No clinical data or test set provenance (country of origin, retrospective/prospective) is provided.

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 surgical instrument, not an AI diagnostic tool requiring expert-established ground truth on clinical images or data. Performance assessment would involve engineering and surgical precision measurements, not expert review of diagnostic interpretations.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in this 510(k) summary.

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-assisted device, and no MRMC study was conducted or is relevant to its approval.

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

Not applicable. This is a surgical instrument operated by a human, not an algorithm.

7. The type of ground truth used

For a physical device like a trephine, "ground truth" would relate to the physical measurement of cuts made (e.g., depth, diameter, consistency), likely established through engineering measurements and potentially ex-vivo tissue testing, rather than clinical outcomes or diagnostic accuracy. The document does not specify the methods used, but for substantial equivalence, it would involve demonstrating that cuts are comparable to those made by the predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is relevant for this device.

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

Not applicable. No AI/machine learning training set is relevant for this device.

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The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Amoils Epithelial Scrubber:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define formal, quantitative acceptance criteria for the Amoils Epithelial Scrubber. Instead, it relies on comparison to a predicate device and qualitative assessments based on an eye bank study and a human study. Here's a table summarizing the implicit "acceptance criteria" (based on predicate device characteristics and desired outcomes) and the reported device performance:

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

• Test Set 1 (Eye Bank Study):

  • Sample Size: "eyes drawn from an eye bank" - The exact number of eyes is not specified.
  • Data Provenance: Not explicitly stated, but likely from a local eye bank given the manufacturer's location in South Africa. This would be retrospective in terms of using donated eyes for laboratory testing.

• Test Set 2 (Human Study):

  • Sample Size: "500 human eyes"
  • Data Provenance: Conducted in South Africa. This was a prospective study where the device was used on human patients.

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

• Eye Bank Study:

  • Number of Experts: Not specified.
  • Qualifications: Not specified, but the ground truth was established by SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy) photos. These analyses would typically be performed and interpreted by highly trained specialists (e.g., histologists, pathologists, or researchers with expertise in microscopy), but the document does not name them or their specific qualifications.

• Human Study:

  • Number of Experts: Not specified.
  • Qualifications: "surgeon" is mentioned as visualizing the epithelial removal. The assessment of "quick healing" and "equivalence to reported speed" would have been made by the operating surgeons and/or clinical researchers. No specific qualifications beyond "surgeon" are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1).

• For the eye bank study, the "ground truth" was derived directly from the physical characteristics observed via SEM and TEM.
• For the human study, the observations (removal time, quick healing) were likely made by the operating surgeons and recorded. There's no mention of a separate adjudication process for these clinical observations.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone (algorithm only) performance study was not done. This is a mechanical device, not an algorithm. The performance described is of the device as used by a human surgeon.

7. The Type of Ground Truth Used

• Eye Bank Study:

  • Pathology/Histology (Microscopy): The ground truth for surface smoothness and damage to Bowman's layer was established by SEM and TEM photos. This is a direct physical assessment at a microscopic level.

• Human Study:

  • Clinical Observation/Outcomes Data: The ground truth for removal time and healing was based on clinical observation by the surgeons and subsequent patient outcomes (e.g., rapid central epithelium regrowth).

8. The Sample Size for the Training Set

The document describes pre-market studies for a medical device and does not mention any "training set." This type of device does not involve machine learning or AI that would require a training set in the conventional sense. The studies described are validation studies.

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

Not applicable, as no training set was used.

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