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510(k) Data Aggregation
(67 days)
CARRIAZO BARRAQUER MICROKERATOME
The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.
The CARRIAZO BARRAQUER microkeratome system composition includes: a) Power unit, b) Keratome head, c) Keratome blade, d) Motor, e) Footswitches, f) Applanator lenses, g) Suction rings. The power unit includes pumps for producing vacuum and can operate the keratome by means of a 12 V DC motor or by means of a nitrogen motor. The keratome head adapts to the turbine or to the motor and includes the blade. Different heads are available to adjust the thickness of the cut. The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome. The applanator lenses are made of clear methylmethacrylate with a stainless steel handle and are used with the rings to control disk diameter before the cut.
Here's an analysis of the provided text regarding the MORIA CARRIAZO BARRAQUER microkeratome, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and a detailed study explicitly proving the device meets them are not directly stated. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against predefined numerical targets.
However, we can infer the implicit "acceptance criteria" through the comparative statements made for substantial equivalence and the intended use. The performance is then deemed "met" by stating equivalence.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Creation of circular lamellar resection of the cornea of predetermined diameter and thickness. | "The CARRIAZO BARRAQUER keratome performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness..." (Section 7) |
| No raising of new issues of safety and effectiveness. | "...and do not raise new issues of safety and effectiveness." (Section 7) |
| Functionality in creating lamellar resection for surgery or other treatment. | "The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea..." (Section 6 & Indications for Use) |
| Ability to operate using a power unit (AC/DC) with pumps for vacuum, displays, and connectors. | Device description details a power unit with these features (Section 5a). |
| Ability to operate with a motor (turbine or electric DC). | Device description details both turbine and electrical 12V DC motor options (Section 5b). |
| Ability to adapt various keratome heads to adjust cut thickness. | Device description states "Different heads are available in order to adjust the thickness of the cut." (Section 5c) |
| Ability of suction rings to fixate and pressurize the eye and provide a base with precision guideways. | Device description details suction rings with these functions (Section 5d). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a specific test set with a sample size. The demonstration of safety and effectiveness is based on the claim of substantial equivalence to legally marketed predicate devices, not on a new, independent clinical or performance study with a defined test set.
- Sample Size: Not applicable/not provided for a specific test set.
- Data Provenance: Not applicable, as no new clinical or performance data is presented. The claim relies on the established safety and effectiveness of the existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no new test set or clinical study is described, there's no mention of experts establishing ground truth for such a set within this document. The "ground truth" for the device's acceptability is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
As there is no described test set that required human adjudication, no adjudication method is mentioned or applicable in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned in this document. The submission relies on substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a surgical instrument (microkeratome), not an algorithm or a diagnostic tool with a standalone performance. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. Its performance is always inherent in its use by a surgeon.
7. The Type of Ground Truth Used
The "ground truth" relied upon for this submission is the historical regulatory approval and established safe and effective use of the predicate devices (PLANCON microlamellar keratome, HANSA Automatic corneal shaper, and HANSA Hansatome) that have been used for similar intended purposes for years. The assumption is that if this new device performs "equivalently," its safety and effectiveness are also established.
8. The Sample Size for the Training Set
There is no mention of a training set in this document. This submission is for a physical medical device, not a machine learning or AI-based system that would typically employ training sets.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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