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VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

This device is for Prescription Use (Rx) only.

VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.

I am sorry, but the provided text is a 510(k) summary for a medical device (VISULAS yag), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria and device performance results as requested.

The document does not contain:

• A table of acceptance criteria and reported device performance for a specific study.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study.
• Details regarding training set size or how ground truth was established for a training set.

Instead, the document primarily compares the subject device's indications for use and technical characteristics to two predicate devices (Ellex YAG Laser K212630 and VISULAS YAG III K042139) to establish substantial equivalence. It mentions "Non-Clinical Performance Testing" and "functional and system level testing showed that the system met the defined specifications," and "Software verification and validation testing were conducted... All testing passed," but these are general statements and do not provide the detailed study information you've asked for.

Therefore, I cannot fulfill your request based on the provided text.

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This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

The VISULAS YAG III™is a Neodymium : Yttrium : Garnet (Nd: YAG) laser for ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. The device operates at a wavelength of 1064 nm. The beam diameter is 10 um with a pulse length of <4 ns. The maximum energy output per pulse is 10 mJ.

This 510(k) submission for the Carl Zeiss Meditec AG VISULAS YAG III™ is for a medical device (a laser) and not a diagnostic AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are geared towards evaluating the performance of AI algorithms, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (VISULAS YAG IIplus™) based on traditional medical device regulatory requirements.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The VISULAS YAG III™ is a physical laser instrument used for ophthalmic procedures. It does not incorporate any AI or machine learning algorithms for diagnosis, prediction, or image analysis.
• Performance Metrics Differ: Acceptance criteria for a laser device typically relate to its physical specifications (e.g., wavelength, pulse duration, energy output, beam diameter, safety features) and its ability to perform its intended physiological functions safely and effectively. These are not reported in terms of diagnostic metrics like sensitivity, specificity, or AUC.
• Study Design Differs: The "study" referenced in this 510(k) is an internal comparison to a predicate device, focusing on functional equivalence and safety testing, not clinical performance studies with human readers or ground truth established by experts in an AI context.

Summary of available information as per the prompt's categories (with clarifications on why AI-specific aspects are not present):

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

   • Acceptance Criteria for a Laser: These would typically involve engineering specifications (e.g., maximum energy output per pulse, beam diameter, pulse length, wavelength) and safety standards compliance. These are established internally by the manufacturer and are not explicitly listed as "acceptance criteria" in this summary.
   • Reported Device Performance: The document states:
     • Wavelength: 1064 nm
     • Beam diameter: 10 um
     • Pulse length: <4 ns
     • Maximum energy output per pulse: 10 mJ
   • The overall "performance" is concluded to be "safe and effective for its intended use" based on testing deemed necessary to demonstrate substantial equivalence to the predicate. This is a regulatory conclusion, not a clinical performance metric against a specific threshold.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML evaluation. The device undergoes engineering verification and validation testing, which often involves testing units against specifications, but not against a dataset for algorithmic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth is established by experts for an AI algorithm's performance in this context. The "ground truth" for a laser device is its adherence to design specifications and its ability to perform its intended physical action (e.g., sever tissue) in a controlled manner.

4. Adjudication method: Not applicable. There is no adjudication of algorithmic outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm. The device's "standalone" performance refers to its ability to function as designed independently.

7. The type of ground truth used: Not applicable in the AI/ML sense. For a laser device, "ground truth" would be established by engineering standards, physical measurements, and possibly preclinical (animal) or limited clinical testing to confirm safe and effective operation within its physical parameters.

8. The sample size for the training set: Not applicable. There is no "training set" for a physical device.

9. How the ground truth for the training set was established: Not applicable.

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