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The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.

Bladeworks Microkeratome Blade

This letter is a 510(k) clearance letter from the FDA for a medical device (Bladeworks Microkeratome Blade). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or study design.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Mention of any multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Details on standalone algorithm performance studies.
6. The type of ground truth used in such studies.
7. Sample size for a training set or how its ground truth was established, as these are typically relevant for AI/ML device studies, which this device pre-dates.

The letter focuses on regulatory clearance, not on a detailed scientific study. Its main purpose is to confirm substantial equivalence and allow the device to be marketed.

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The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers.

Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.

The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN guides the laser energy over the skin during removal of soft tissue under the conditions of labeling as described in the laser operator's manual.

The provided document is a 510(k) summary for the JENOPTIK JENASCAN, a laser accessory. It explicitly states that no performance data were required or provided because the device is considered substantially equivalent to already legally marketed predicate devices. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.

The relevant section from the document states:

"Performance Data: None. The specifications and intended uses of the Jenoptik JENASCAN are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

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