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The ONE UP disposable keratome head 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 ONE UP disposable keratome head and suction ring are identical in design, concept and principle to the predicate PLANCON microlamellar keratome single piece head K 970 377, the only difference being that the keratome head, the ring and the handle are made of high density plastic material. The stainless steel blade and the plastic blade holder are similar to the blade and blade holder of the above predicate. The keratome head has dovetails guides which engage in the dovetails of the suction ring. The blade oscillates by means of the same turbine of the predicate device referred above. The power unit is similar in characteristics, principles and functions to the power units of legally marketed keratomes. The ONE UP disposable keratome head comes preassembled and presterilized in a copolyester sealed tray, sealed with TYVEK ® peel off cover. The sterilisation is performed under validated gamma radiation cycle with sterility assurance level of 10 ° and dosimetric release. The plastic materials used for patient contact portion of device have been tested according to classification of USP and the grades used passes classes I through VI, and are deemed to be biocompatible.

The provided document focuses on the substantial equivalence of the MORIA ONE UP disposable keratome head to predicate devices and does NOT contain information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement as requested.

The submission is a 510(k) premarket notification, which primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing design, materials, and intended use, rather than extensive new clinical trials or performance studies with specific acceptance criteria as might be seen for novel devices or PMA submissions.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document states: "The ONE UP disposable keratome head performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness, and do not raise new issues of safety and effectiveness." (Section 7. Discussion of tests and results). This statement is the core of their "proof" of meeting safety and effectiveness, based on substantial equivalence to existing devices.

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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.

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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