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The MR Q and the MR SUPINE are intended to perform:

• Posterior capsulotomy -
• Iridotomy -

The MR Q SLT in YAG mode is intended to perform:

• Posterior capsulotomy -
• -Iridotomy

The MR Q SLT in SLT mode is intended to perform:

• Selective laser trabeculoplasty

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and specific performance metrics of the device.

The document is a 510(k) clearance letter from the FDA, which confirms that the device (Meridian AG's MR Q, MR Q SUPINE, MR Q SLT) is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and general information but does not include the results of clinical studies, acceptance criteria, or detailed performance data for the device.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) studies or the effect size of AI assistance.
• Results from standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample sizes for training sets or how ground truth for training data was established.

The "Indications for Use" section (page 3) describes what the device is intended to do (e.g., Posterior capsulotomy, Iridotomy, Selective laser trabeculoplasty), but not the performance metrics or studies used to demonstrate those capabilities.

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The MERILAS 810 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty
• Thermotherapy

The MERILAS 532 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomv
• Trabeculoplasty

The MERILAS 577 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty

Not Found

I apologize, but the provided text is an FDA 510(k) clearance letter for three ophthalmic laser devices (Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse). This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria, specifically for an Artificial Intelligence (AI) enabled device.

The document primarily focuses on:

• Confirmation of 510(k) clearance: Stating that the devices are substantially equivalent to legally marketed predicate devices.
• Regulatory information: Details about class II classification, compliance requirements, and contact information.
• Indications for Use: Listing the medical conditions each Merilas laser model is intended to treat (photocoagulation, iridotomy, trabeculoplasty, thermotherapy).

Since the request specifically asks for details about acceptance criteria and a study proving an AI device meets them, and the provided text does not contain any such information, I cannot fulfill the request based on this document.

To answer your question, I would need a different type of document, such as a clinical study report, a scientific publication detailing the validation of an AI medical device, or a 510(k) summary specifically for an AI-enabled device that includes performance data.

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The Microruptor 6 Nd: Y AG Laser is indicated for:

• posterior capsulotomy,

• pupillary membranectomy

• peripheral iridotomy

Microruptor 6 Nd: YAG Laser

I am sorry but this document does not contain the information you are requesting. The document is an FDA 510(k) clearance letter for the Microruptor 6 Nd: YAG Laser, which indicates the device has been found substantially equivalent to a predicate device. It specifies the indications for use but does not include details on acceptance criteria and a study proving the device meets those criteria, or any information about AI algorithms.

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The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm. The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.

The provided text is for a 510(k) summary for the LIO-500 device. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance.

Therefore, many of the requested categories related to acceptance criteria, device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, and AI performance metrics are not applicable to this type of regulatory submission.

The LIO-500 is described as a medical device (Laser Indirect Ophthalmoscope 500) intended for photocoagulating ocular tissue in the treatment of eye diseases. It is a delivery system for laser light, not a diagnostic device that processes images or data to provide a medical assessment.

Here's an analysis based on the information provided, explicitly stating what is not applicable:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. The 510(k) summary does not define specific performance acceptance criteria for the LIO-500 itself that would be evaluated in a clinical or non-clinical study for performance metrics like sensitivity, specificity, accuracy, etc. Its regulatory path is based on demonstrating substantial equivalence to a predicate device, which implies that it functions similarly and meets comparable safety and effectiveness standards, not necessarily new quantitative performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No test set or data provenance is mentioned as part of a performance study for the LIO-500 in this 510(k) summary. The submission states, "There are no clinical or non-clinical tests required to show substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment by experts for a test set is mentioned because no such performance study was conducted or required for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is mentioned as no performance study with a test set was conducted or required.

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. The LIO-500 is a laser delivery device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. The LIO-500 is a hardware device for laser delivery and does not involve an algorithm or AI. Standalone performance for an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No ground truth for a performance study is mentioned or relevant to this 510(k) submission.

8. The sample size for the training set

• Not Applicable. The LIO-500 is a hardware device and does not involve AI or algorithms that require a training set.

9. How the ground truth for the training set was established

• Not Applicable. As no training set is involved, the establishment of its ground truth is not applicable.

Summary of the K113390 Submission:

The LIO-500 received 510(k) clearance based on its substantial equivalence to the predicate device, VISULAS 532S (K013402). The key statement from the provided text is: "The LIO-500 has the same technical characteristics as the VISULAS 532S. There are no clinical or non-clinical tests required to show substantial equivalence." This means that the FDA determined that the LIO-500 is as safe and effective as the predicate device based on its design, materials, and intended use, without requiring specific performance studies that measure metrics like sensitivity or specificity.

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The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.

The methods for delivery of the laser treatment beam to the desired tissue in the eye are:

• Slit lamp delivery device (also identified as: slit lamp adapter) such as the SLA-. BMBQ
• Laser indirect ophthalmoscope .
• . Endo fiber

The delivery method can be altered by exchanging the appropriate delivery device and connecting it to the base laser unit. The Autokey connector which belongs to each delivery device ensures that the base laser unit always gets the necessary information about the attached delivery device. The required delivery device has to be connected to the base laser unit before turning on the base laser unit.

During the start up procedure the MERILAS 532« identifies the attached delivery device and internally sets the appropriate parameters. The MERILAS 532α laser itself has built in sensors which do not allow the laser to fire if the delivery device fitted is not suitable in anwav.

For better viewing of the status of the laser unit when space is limited the display unit including the input devices can be removed from the base laser unit and placed on a more convenient space where good access as well as good viewing is possible. The maximum distance the display unit can be placed away from the base laser unit is 1 m due to maximum cable length.

After adjusting the desired parameters on the display of the base laser unit the treatment mode can be selected. In the treatment mode the red aiming beam (635 nm), generated by a laser diode, gets started and indicates the user to which area the treatment beam will be released. The physician selects the target tissue by aiming the red aiming beam to the desired tissue before releasing the treatment pulse.

The treatment laser is a diode pumped Nd: YVO laser which gets frequency doubled by using a KTP crystal. It is radiating at 532 nm. The transmission of the laser light gets achieved by focusing the laser light into an optical fiber and transmitting it to the delivery device. Laser power up to 2.5 W can be delivered out of the fiber. The laser delivery time can be adjusted from 10 ms up to 5 s.

The system can be operated from a 90-260 VAC, 50/60Hz single-phase power outlet. The mechanics of the MERILAS 532« is build out of anodized aluminium, painted sheet metal, and copper.

The optional slit lamp adapter SLA-BMBQ guides the laser beam from the laser unit into the illumination set of a slit lamp and focuses to the desired treatment area. The diameter of the spot can be adjusted in a range from 50 um to 5 mm by turning the dial wheel at the slit lamp adapter.

The mechanics of the SLA-BMBQ is build out of anodized aluminium.

This document is a 510(k) summary for the MERILAS 532α Ophthalmic Surgical Laser, confirming its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing with human readers or standalone algorithm performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence to an existing device, not on specific performance studies against pre-defined acceptance criteria for a new clinical or AI-driven application.

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This device will be used in ophthalmic applications, including:

• . Posterior Capsulotomy
• Peripheral Iridotomy .
• Pupillary Membranectomy .

The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has the form of a table containing supply and control electronics and supporting a headrest where the head of the patient is placed, as well as a movable housing that is controlled by a joystick. The housing comprises a biomicroscope with a slit-lamp illumination (Haag-Streit), a Qswitched Nd:YAG laser, a laser diode producing a red (635 nm) aiming beam and optical, mechanical and electronics elements necessary to control the parameters and geometry of the laser beams.

The integrated Q-switched Nd:YAG laser emits short pulses of light at wavelength of 1064 nm. This light is focused in the plane of observation of the ophthalmic microscope. The irradiance at the focal point is high enough to cause optical breakdown, thus permitting the disruption of tissues.

The MICRORUPTOR V allows the physician to adjust the energy delivered to the target tissue and to precisely control and visualize the position of the beam focus, thus allowing a precise and noninvasive dissection of tissues inside the eye of the patient.

This document is for a medical device cleared in 2002, which is before the current requirements for AI/ML device submissions. Therefore, the document does not contain the detailed information typically expected for AI/ML device studies, such as specific acceptance criteria tied to performance metrics, sample sizes for training/test sets, ground truth establishment methods for AI, or comparative effectiveness studies with human readers.

The information provided focuses on demonstrating substantial equivalence to a predicate device, as was the standard practice at that time.

Here's an analysis based on the provided text, highlighting the absence of AI/ML-specific details:

Device: MICRORUPTOR V (Q-switched Nd:YAG laser)
Intended Use: Noninvasive tissue/membrane dissection (photodisruption) in the eye, including posterior capsulotomy, peripheral iridotomy, and pupillary membranotomy.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission from 2002 for a laser device (not an AI/ML device), the "acceptance criteria" are not framed in terms of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, they revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This device is a laser system, not an AI/ML algorithm that operates on a "test set" of data. The submission relies on engineering specifications and comparison to the predicate device, not on data-driven performance metrics from a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. As above, there is no "test set" in the context of an AI/ML algorithm for which ground truth would be established by experts.

4. Adjudication Method for the Test Set

• Not Applicable. There is no test set or adjudication method described for an AI/ML algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a hardware device, not an AI/ML system. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a standalone medical device (laser system), not a standalone AI/ML algorithm intended to analyze data without human intervention. The device is operated by a "skilled Physician."

7. The Type of Ground Truth Used

• Not Applicable. For this laser device, "ground truth" would relate to its physical properties (e.g., energy output, wavelength, beam focus accuracy) and its ability to achieve tissue disruption safely when operated by a physician. This is established through engineering testing and clinical experience with the predicate device, not through expert consensus, pathology, or outcomes data in the context of an AI's diagnostic or predictive output.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, there is no training set for an AI/ML algorithm.

Summary regarding AI/ML Device Study Information:

The provided 510(k) summary for the MICRORUPTOR V laser system does not contain any of the requested information pertaining to AI/ML device studies because the device itself is a traditional medical hardware device, not an AI/ML-driven diagnostic or therapeutic tool. The clearance is based on demonstrating substantial equivalence to a predicate device, which primarily involves comparing specifications, intended use, and technological characteristics.

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