(343 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flap Thickness | "validity of labeled flap thicknesses" provided. (No specific numerical ranges or targets are given in this summary.) |
| Flap Diameter | "validity of labeled... diameters" provided. (No specific numerical ranges or targets are given in this summary.) |
| Hinge Size | Focused on in one study. (No specific numerical ranges or targets are given in this summary.) |
| Consistent and Predictable Performance | "consistent and predictable performance of the device in meeting the clinically-selected parameters" was demonstrated. |
| Safety and Effectiveness | "reasonable assurance of the safety and effectiveness of the Carriazo-Pendular Microkeratome in a clinical setting." |
| Biocompatibility | Tissue-contact materials "have been shown to be biocompatible." |
| Sterilization | Sterilization methods "have been validated to a sterility assurance level of at least 10^-6." |
| Packaging Performance | Packaging "has been tested to assure its performance in maintaining the sterility of the components supplied sterile." |
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.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.