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The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

The Carriazo-Pendular is an AC powered microkeratome. Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges. The Carriazo-Pendular consists of: Carriazo-Pendular console, Cutting heads, Suction rings, Foot switches, Monitoring software.

The provided 510(k) summary for the Carriazo-Pendular Microkeratome (K082043) does not contain detailed acceptance criteria or a comprehensive study report with the level of detail requested. However, based on the available information, I can extract and infer some aspects of the performance and testing.

Here's a breakdown of the requested information, with clear indications of what is explicitly stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Test on pig eyes and clinical performance data on human eyes." However, the exact number of pig eyes or human eyes is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is based in Germany. Clinical data could be from Germany or elsewhere.
  • Retrospective or Prospective: Not specified.

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

This information is not provided in the 510(k) summary. The document does not describe how ground truth was established for the "clinical performance data on human eyes" or for the pig eye tests. There is no mention of expert review or consensus for outcome assessment.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given that the summary does not detail the nature of the "clinical performance data" or how experts established ground truth, an adjudication method is not described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. This device is a microkeratome (surgical instrument), not an AI-powered diagnostic imaging device that typically involves human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply in this context.

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

This question is not directly applicable as the device is a surgical instrument, not an algorithm. The "Pendular Monitoring Software" is mentioned, but its performance is described as for "read out of relevant monitored data... for quality insurance, supporting the doctor in the process of improving the cutting execution and analysis of potential cut complications." This suggests it's an assistive tool for data analysis post-procedure, not a standalone diagnostic or automated system replacing a human operator.

7. The Type of Ground Truth Used

This information is not explicitly stated. For the "Test on pig eyes," the ground truth would likely involve precise measurements of flap thickness and quality (e.g., smoothness of edges, consistency), potentially assessed by histology or optical coherence tomography. For "clinical performance data on human eyes," outcomes could relate to actual flap thickness achieved in surgeries, visual acuity outcomes, or complication rates, but the method for establishing the true flap characteristics against which performance was measured is not described.

8. The Sample Size for the Training Set

This device does not appear to involve a "training set" in the context of machine learning or algorithms that learn from data. The "Pendular Monitoring Software" collects data, but its development is not described as involving a training set in the AI sense. Therefore, the sample size for a training set is not applicable/not provided.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm learning, this question is not applicable.

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The Carriazo Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

The Carriazo Pendular Microkeratome is a Keratome (microkeratome). Selected differences in specifications between the Carriazo-Pendular (CP) Microkeratome and its predicates include head/ring coupling (the CP couples automatically; predicates use manual coupling); the CP vacuum is adjustable to 675 mm Hg; the predicates are constant at 625 mm Hg); the CP has a double-headed vacuum pump and the predicates single-headed vacuum pumps; the CP electronically detects and signals a cable break; the predicates lack this feature); shape of the blade (CP is curved: the predicates are straight); the CP has a ball-shaped cutting head; the predicates are straight; at the stop in final position - the CP is automatic; the predicates are not; the CP has right and left eye rings, the predicates do not; and the CP head is guided by two separate mains; the predicates by a single pivot on the ring only and the head can move up and down during the cut which can result in micro-scattering on the stromal bed).

The Carriazo Pendular Microkeratome is a Class I device used for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Unfortunately, the provided text does not contain a table of acceptance criteria or specific quantitative performance metrics beyond general statements about "consistent and predictable performance" and "validity of labeled flap thicknesses and diameters."

Here's an analysis based on the available information:

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

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

• Sample Size: 200 eyes for the primary clinical study. An additional study was performed with an unspecified sample size (referred to as "another site").
• Data Provenance: The primary study was a clinical study, implying prospective data collection in a clinical setting. The country of origin is not explicitly stated for the primary 200-eye study, but the manufacturer is German, and "another site (Dr. Maria Arbelaez)" is mentioned for the additional study, potentially indicating international data.

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

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the clinical studies. It mentions "Dr. Maria Arbelaez" as a site for an additional study, implying a clinician's involvement.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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 a microkeratome, not an AI-assisted diagnostic device for human readers.

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

Not applicable. This is a surgical device, not an algorithm. The performance described refers to the device's mechanical and functional output.

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

The ground truth for the device's performance (flap thickness, diameter, hinge size) would likely be based on direct measurements taken during or after the procedures, compared against the device's labeled specifications and clinical expectations. Safety and effectiveness would be assessed through clinical observations and outcomes data (e.g., absence of adverse events, successful flap creation). The document states "clinical studies" and "clinically-selected parameters."

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model that requires a training set. The "studies" mentioned are performance validation studies.

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

Not applicable, as there is no training set for this type of device.

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