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The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

Acceptance Criteria and Device Performance Study for Quantel Medical Pocket III

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.

The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect. Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam. As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated. The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.

The provided text is a 510(k) summary for the Quantel Medical CAPSULO device, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML-driven device.

Therefore, the information required to answer the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and training set information for an AI/ML device is not present in the provided document.

The document discusses the following:

• Device Type: Nd: YAG ophthalmic laser (not an AI/ML device).
• Purpose: Photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy).
• Equivalence: The submission claims substantial equivalence to a predicate laser device (Quantel Medical Optimis Fusion).
• Performance Data: States non-clinical testing was performed to verify design specifications and substantial equivalence, and lists the standards adhered to (electrical safety, EMC, usability, laser safety, biocompatibility). It also mentions software verification and validation activities for a "Major level of concern," but this refers to the software controlling the laser, not a diagnostic AI algorithm.

In summary, there is no information in the provided text about acceptance criteria for an AI/ML device's performance, nor any study details that would typically be conducted for verifying an AI/ML model's diagnostic accuracy or effectiveness.

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The AXIALIS Ophthalmic Ultrasound System and the probes that are indicated for diagnostic imaging and biometric measurement of the eye including:

• · Axial Length measurement of the eye by ultrasonic means.
• · Implanted IOL power calculation, using the Axial Length measurement.
• · Measurement of corneal thickness by ultrasonic means.

The AXIALIS Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology which consists of a base and probes. The base performs the same calculations and displays as the predicate device, the Quantel Medical COMPACT TOUCH. The A-scan probe for biometry and pachymetry is identical to the predicate device.

The provided text is a 510(k) summary for the Quantel Medical AXIALIS Ophthalmic Ultrasound System. It details the device's indications for use, its substantial equivalence to a predicate device (Quantel Medical Compact Touch Ophthalmic Ultrasound System), and the performance data submitted for its clearance.

However, the document focuses on non-clinical testing related to electrical safety, EMC, usability, and specific requirements for ultrasonic medical diagnostic equipment, as well as hardware and software validation. It does not contain information about clinical performance studies regarding diagnostic accuracy, sensitivity, specificity, or how the device's measurements compare to a "ground truth" or to human readers' performance.

Therefore, I cannot fully answer your request based on the provided text, especially regarding:

• Acceptance criteria and reported device performance related to diagnostic accuracy. The text mentions "biometric measurement of the eye," but no data on the accuracy of these measurements is provided.
• Sample size used for a clinical test set or data provenance.
• Number of experts, qualifications, or adjudication methods for establishing ground truth.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (clinical/pathology/outcomes data).
• Training set size or ground truth establishment for a training set.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical performance (safety, EMC, usability, software validation) rather than direct clinical accuracy studies with human participation.

To answer your questions, clinical study data would be required, which is not present in this 510(k) summary.

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The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
Retinal photocoagulation for the treatment of:
Diabetic retinopathy including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal Tears, Detachments and Holes
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and Branch Retinal Vein Occlusion
Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including:
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)

The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the anterior and posterior segments of the eye. The laser is particularly well suited for treating the eye because it has minimal effect on transparent tissues and materials. This means that the laser can be efficiently delivered to opaque structures of the eye through the transparent cornea, aqueous humor, lens, and vitreous humor. This allows many conditions to be treated by non-invasive techniques.
Laser energy is delivered to opaque structures within the eye by means of laser delivery systems including slit lamp, indirect ophthalmoscope, operating microscope, cyclophotocoagulation probe and laser probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. The laser energy is delivered to the delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens may have mirrors so that laser energy can be delivered to areas of the retina behind the iris, or into the angle so that the trabecular meshwork can be treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.

The Quantel Medical Vitra 810 is an ophthalmic laser system intended for photocoagulation of ocular tissues in the treatment of diseases of the eye, specifically retinal diseases and glaucoma.

Here's an analysis of the acceptance criteria and the study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, substantial equivalence is claimed based on comparing the technological characteristics and intended use of the Vitra 810 with two predicate devices. The "Performance Data" section primarily lists compliance with recognized consensus standards related to safety and essential performance, as well as hardware and software validation. These can be considered the implicit acceptance criteria, demonstrating that the device meets established regulatory and technical benchmarks.

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

The document does not describe a clinical test set with a specific sample size, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The assessment for substantial equivalence is based on a comparison of technical specifications and intended use against legally marketed predicate devices, along with compliance to international safety standards. It does not appear to involve a new clinical study with a patient test set in the traditional sense.

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

This information is not applicable as the documentation does not describe a clinical study with a test set requiring expert-established ground truth. The device is a medical laser, and its substantial equivalence is determined by engineering and regulatory comparisons, not by diagnostic performance against an expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not applicable, for the same reasons as point 3.

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

This information is not applicable. The Vitra 810 is a surgical laser device (a treatment tool), not a diagnostic device or an AI-assisted diagnostic tool. Therefore, an MRMC study assessing human reader improvement with AI assistance is irrelevant for this type of medical device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Vitra 810 is a medical laser system operated by trained medical personnel. It is not an algorithm-only or AI-based device, so standalone algorithm performance testing is irrelevant.

7. The Type of Ground Truth Used

This information is not applicable. As discussed, the substantial equivalence decision is based on technical specifications, intended use, and compliance with safety standards, rather than the performance of a diagnostic algorithm against a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a training set as the device is not an AI/ML-based system requiring data for training.

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

This information is not applicable, for the same reasons as point 8.

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The Vitra 2 is for use in the treatment of ocular pathology of anterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:

• · Proliferative and nonproliferative diabetic retinopathy
• Choroidal neovascularization
• · Branch retinal vein occlusion
• · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
• · Retinal tears and detachments
• · Macular edema

The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.Laser energy is delivered to opaque structures within the eye by means of delivery systems including slit lamp, indirect ophthalmoscope, operating microscope and endocular probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. It also includes a Multispot delivery system made by scanner motors which can deliver several spots to the retina in a pattern. The laser energy is delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.

The Quantel Medical VITRA 2 includes a Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp. Once activated by the user, the VITRA 2 delivers a predetermined pattern by sequentially scanning the placement of the laser spots and the emission of the individual pulses of laser light. Treatment is initiated by pressing the footswitch and may be aborted by releasing the footswitch.

The provided text is a 510(k) summary for the Quantel Medical Vitra 2 device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Quantel Medical Vitra Multispot).

However, the information requested in your prompt (Acceptance Criteria and a study proving the device meets the criteria, particularly in the context of an AI/ML-driven device) is not present in this document. The Vitra 2 is a laser surgical instrument, and its performance data focuses on compliance with electrical and laser safety standards (IEC 60601 series, IEC 60825-1) and hardware/software validation. There is no mention of AI/ML components, a test set, expert readers, ground truth establishment for a diagnostic algorithm, or MRMC studies.

Therefore, I cannot fulfill your request using the provided text. The requested information pertains to a different type of device evaluation (typically for AI/ML-based diagnostic or prognostic tools) than what is described for the Vitra 2 laser system.

To illustrate, if this were an AI/ML device document, the "Performance Data" section would ideally contain details such as:

• Acceptance Criteria Table: Specific metrics (e.g., accuracy, sensitivity, specificity, AUC) with a pre-defined threshold that the device's performance must meet.
• Study Design: Description of the test set, sample size, data provenance, and how ground truth was established.
• Expert Consensus: Details on the number and qualifications of experts involved in ground truth labeling and any adjudication process.
• MRMC Study: Information on comparative effectiveness studies, if human readers were assisted by the AI.
• Standalone Performance: Results when the algorithm performs without human intervention.
• Training Set Details: Information on the size and ground truth establishment for the data used to train the AI model.

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The Quantel Medical ABSOLU is intended to be used for:

-Axial Length measurement of the eye by ultrasonic means;

-Implanted IOL power calculation, using the Axial Length measurement;

• Visualization of the interior of the eye and the orbit by A and B scans.

The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:

• -Axial Length measurement of the eye by ultrasonic means;
• Implanted IOL power calculation, using the axial length measurements; -
• Visualization of the interior of the eve and the orbit by A and B scans. -

The Quantel Medical ABSOLU device is intended for axial length measurement of the eye, implanted IOL power calculation using axial length measurements, and visualization of the interior of the eye and orbit via A and B scans. The performance data and acceptance criteria are outlined below, primarily focusing on safety and compliance with recognized standards rather than specific diagnostic accuracy metrics of a standalone AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes tests performed for regulatory compliance (safety, EMC, usability, and ultrasonic equipment safety standards) and validation of technological changes. It does not mention a specific "test set" in the context of clinical data for diagnostic or measurement accuracy of a standalone AI algorithm. The performance data refers to instrumental performance, safety, and functional validation against standards for the device as a whole and its components (probes, software). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available in this document.

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

This information is not provided in the document, as the evaluations described are primarily for device safety, EMC, usability, and technical performance against engineering standards, not a clinical diagnostic performance study with expert-adjudicated ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document, as the evaluations described are for device safety and technical performance, not for clinical diagnostic performance adjudicated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present in the document. The device is an ultrasound system with specific measurement and visualization capabilities, and the performance data focuses on its compliance with operational, safety, and technical standards, rather than an AI-driven diagnostic accuracy study comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone performance study for an AI algorithm without human intervention. The ABSOLU is described as an "ultrasonic pulsed echo imaging system" intended for use by "trained medical personnel" where "the use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic." This strongly suggests a human-in-the-loop system, not a standalone AI.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not detail specific "ground truth" for clinical diagnostic or measurement accuracy in the context of expert consensus, pathology, or outcomes data. The "performance data" mentioned pertains to compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and ultrasonic medical device safety. These standards serve as the "ground truth" for the device's technical and safety performance.

8. Sample Size for the Training Set

No information regarding a training set sample size is provided. The document outlines a regulatory submission for an ultrasound imaging system, not an AI algorithm that typically requires a large training dataset for its development. The "software" mentioned as being revised is general device software, not an AI component trained on data.

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

Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for such a set was established.

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The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:

• Visualization of the interior of the eye and the orbit by A and B scans.
• Axial Length measurement of the eye by ultrasonic means.
• Implanted IOL power calculation, using the Axial Length measurement.
• Measurement of corneal thickness by ultrasonic means.

The COMPACT TOUCH Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial or performance study report. Instead, it is a 510(k) summary for a medical device (COMPACT TOUCH® Ophthalmic Ultrasound System) seeking FDA clearance based on substantial equivalence to an existing predicate device (K094038).

The document focuses on explaining that the new device has the same indications for use and similar technological characteristics to the predicate device, with some minor modifications. The "performance data" section primarily lists compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and particular requirements for ultrasonic medical diagnostic equipment. It also mentions hardware and software validation activities.

However, I can extract the relevant information regarding the performance improvement stated and the basis for equivalence as outlined in the document.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for a full "acceptance criteria and study results" breakdown.

Device Name: COMPACT TOUCH® Ophthalmic Ultrasound System

Predicate Device: Quantel Medical Compact Touch (K094038)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific thresholds (e.g., sensitivity, specificity, accuracy targets) for its diagnostic functions or biometric measurements, as would be typical for a clinical performance study. Instead, the "acceptance criteria" are implied by showing equivalence to the predicate and highlighting an improvement in measurement accuracy for one specific probe.

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

The document does not specify a sample size for a test set or test subjects for evaluating the improved measurement accuracy (± 0.115 mm). It states that the improvement is "due to the increase of the frequency of the probe" and that "IEC 60601-2-37 tests have been followed...". This suggests the performance claim for accuracy is likely derived from laboratory testing or phantom measurements, rather than a clinical study on a patient population.

Data provenance (country of origin, retrospective/prospective) and details of the "test set" are not provided, as it seems no clinical human subject test set was used for the accuracy claim or overall equivalence beyond technical standard compliance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical test set with human subjects is described for evaluating the stated performance improvement, there is no mention of experts being used to establish ground truth in such a context. The evaluation appears to be based on technical specifications and compliance with standards.

4. Adjudication Method for the Test Set

As no clinical test set for human subject performance validation is described, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any assessment of human readers improving with or without AI assistance. This device is an ultrasound system purely for diagnostic imaging and biometric measurement, not an AI-powered diagnostic interpretation tool.

6. Standalone (Algorithm Only) Performance Study

The document describes the device as an "Ophthalmic Ultrasound System" which performs imaging and measurements. It mentions "calculations" and "software revised to accommodate the other device changes". However, there is no standalone algorithm-only performance study described in the context of diagnostic interpretation or classification. The performance discussed relates to the physical measurement capabilities of the ultrasound system.

7. Type of Ground Truth Used

For the improved measurement accuracy of ± 0.115 mm, the ground truth is implicitly derived from technical specifications and calibration procedures of the ultrasound system, likely using phantoms or reference standards in a laboratory setting, rather than expert consensus, pathology, or outcomes data from human subjects. The primary "ground truth" for the overall device's safety and effectiveness in the context of this 510(k) is its substantial equivalence to the predicate device, which itself would have undergone its own validation.

8. Sample Size for the Training Set

This document pertains to a hardware device with associated software for measurement and display. It is not an AI/Machine Learning device that undergoes a "training" process with a large dataset. Therefore, there is no training set sample size mentioned.

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

As it is not an AI/Machine Learning device, there is no training set and consequently no ground truth establishment process for a training set mentioned.

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The Easyret® is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and uvea including:

• Proliferative and severe nonproliferative diabetic retinopathy,
• Choroidal neovascularization
• Branch retinal vein occlusion
• Treatment of choroidal neovascularization associated with wet age-related macular degeneration
• Retinal tears and detachments,
• Certain forms of macular edema
• Retinopathy of Prematurity
• Iridotomy in angle closure glaucoma, and trabeculoplasty in open angle glaucoma

Easyret® is an integrated photocoagulation laser system including a slit lamp and a single column table. It provides a yellow laser beam (577nm).

Easyret® laser is available with the following configurations: - A single slit lamp delivery system: With this model two different slit lamps manufactured by CSO (CSO SL 9800 5x and CSO SL 9900 5x) are available. These slit lamps models have been cleared under K992836. - A slit lamp delivery system and a laser indirect ophthalmoscope (LIO) optional port In addition to the slit lamp delivery system, an optional LIO (laser indirect ophthalmoscope) can be used with the laser. Quantel Medical recommends the use of the following LIO models: Heine Omega 500 and Keeler Vantage +.

The touch screen includes a user interface where laser treatment settings such as power, pulse duration, spot size treatment and aiming beam intensity level can be programmed.

The user interface allows the physician to quickly select and access the following 3 treatment modes:

• Monospot treatment: This selection allows the user to carry out thermal "traditional" laser treatment using single spot via 4 delivery modes: Single, Repeat, Painting or Continuous.
• -MultiSpot treatment: The MultiSpot mode allows automatically consecutive several laser spots according a pattern selected and the treatment patterns are customizable: square, circle, triple arc and macular grid.
• SubLiminal treatment: The sequencing (SubLiminal mode, or sub-threshold) is used to split the energy delivery into several successive very short pulses (microseconds) separated by a cooling time (interval).

Feedback to the user, such as laser operating state, number of performed laser spots, etc. is provided through the user interface. The laser treatment can be initiated by pressing on a footswitch and aborted by releasing it.

This document is a 510(k) premarket notification for a medical device called Easyret®, an ophthalmic laser system. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device (Quantel Medical Supra Scan K120825). Therefore, the document does not contain information related to acceptance criteria, device performance details from a study proving it meets those criteria, sample sizes, expert qualifications, or comparative effectiveness studies in the way typically associated with clinical performance validation of diagnostic AI/ML devices.

The document primarily focuses on:

• Indications for Use: The Easyret® is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and uvea, as listed in pages 2 and 4-5.
• Device Description: Easyret® is an integrated photocoagulation laser system including a slit lamp and a single column table, providing a yellow laser beam (577nm). It supports Monospot, MultiSpot, and SubLiminal treatment modes (page 4).
• Substantial Equivalence Argument: The core of the submission is to demonstrate that Easyret® is substantially equivalent to the predicate device (Quantel Medical Supra Scan). This is argued based on:
  • Same intended use/indications for use (page 5).
  • Similar technological characteristics: Both use a 577nm laser. Differences primarily relate to the integration of components (scanner and zoom integrated into the slit lamp in Easyret® vs. added to the slit lamp in the predicate) and the type of laser cavity (fiber laser cavity in Easyret® vs. Optically Pumped Semiconductor Laser (OPSL) cavity in the predicate) (page 5-6).
  • Similar performance parameters: While some ranges (exposure time, spot size) have been slightly adjusted, the document states that the delivered power, spot size, and exposure time can be adjusted in the same ranges as the predicate, resulting in the same range of fluence delivered (page 6).
• Performance Data: This section only lists the recognized consensus standards to which performance testing was conducted (e.g., electrical safety, electromagnetic compatibility, usability, particular requirements for surgical laser equipment, laser product safety). It also states that hardware and software validation activities were performed and appropriate software documentation was provided. It does not provide specific performance results, acceptance criteria, or a study report demonstrating the device's clinical performance against acceptance criteria.

Therefore, based on the provided document, I cannot answer the requested questions regarding acceptance criteria and performance data for a study proving the device meets those criteria, including sample sizes, ground truth establishment, or any comparative effectiveness studies, because this information is not present in the 510(k) summary.

The document's purpose is a regulatory submission for substantial equivalence to a predicate laser device, not a detailed clinical performance study of a diagnostic or AI/ML device. It focuses on engineering and regulatory compliance rather than clinical trial results with performance metrics against predefined acceptance criteria for AI algorithms.

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OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
OPTIMIS FUSION SLT: Selective Laser Trabeculoplasty
OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective Laser Trabeculoplasty

The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of the pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser Trabeculoplasty.

The Family of OPTIMIS FUSION Ophthalmic Lasers. Delivery Device and Accessories consists of the following models:

1. OPTIMIS FUSION YAG a Nd: YAG Laser providing-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy/iridectomy). The 1064 treatment beam delivers 4 ns, 0.3 -10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned trough beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 10 um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 150um in the posterior direction and -150um in the anterior direction by the physician relative to this convergence of the twin aiming beams.
2. OPTIMIS FUSION SLT a Nd: YAG Laser providing Q-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. The treatment beams delivers a 4 nsec. 0.3-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focussed by the slit lamp objective to a 400um spot at the focal point of the lens.
3. OPTIMIS FUSION YAG/SLT a Nd: YAG Laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or O-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. depending upon the mode selected. The OPTIMIS FUSION YAG/SLT contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.

For each OPTIMIS FUSION model, the physician controls delivery of laser energy from the OPTIMIS FUSION control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp adaptor may be coupled to each of the above OPTIMIS FUSION models and connected to a currently cleared QUANTEL MEDICAL 532nm photocoagulator (VITRA (K04236), SUPRA (K07776), VITRA MULTISPOT (K122251)) to allow to the physician to use the Slit Lamp Adaptor to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

The OPTIMIS FUSION produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.

When the photodisruptor mode is selected, the treatment wavelength is 1064nm. A twinaiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.

When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Quantel Medical OPTIMIS FUSION Ophthalmic Laser Systems:

Disclaimer: This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical efficacy or accuracy against a defined ground truth in a clinical study. Therefore, many of the typical elements sought for evaluating AI/diagnostic device performance will not be explicitly present.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not delineate specific, quantifiable "acceptance criteria" in the format of a diagnostic performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices. This means the device is deemed acceptable if its technological characteristics and intended use are similar enough to previously cleared devices that it raises no new questions of safety or effectiveness.

The "device performance" reported is also in terms of technological characteristics and similarity to predicate devices, rather than clinical outcome or diagnostic accuracy metrics.

• Wavelength: 532 nm (Same as Selecta SLT, Solutis)
• Pulse Mode: Single pulse (Same as Selecta SLT, Solutis)
• Energy Range: 0.3-2.0 mJ (Same as Selecta SLT; Solutis is 0.2-2.0 mJ - considered minor difference)
• Spot Size in Air: 400 microns (Same as Selecta SLT, Solutis)
• Focus Angle:

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The SOLUTIS Laser is indicated for use in: Selective Laser Trabeculoplasty (SLT)

SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.

The provided text is a 510(k) Summary for the Quantel Medical SOLUTIS, an ophthalmic laser system. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving acceptance criteria for device performance in a clinical or diagnostic context, especially not one that would involve AI, human readers, ground truth establishment, or sample sizes as typically inquired about for AI/ML-based medical devices.

Instead, the performance data section states:
"Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."

This indicates that the "acceptance criteria" were related to engineering design specifications and technical parameters to show equivalence to existing devices in a laboratory setting, rather than clinical efficacy or diagnostic accuracy.

Therefore, most of the requested information regarding acceptance criteria and a study proving device meets them (especially those pertaining to AI, human reader performance, ground truth, and sample sizes of a test or training set) cannot be extracted from this document as it does not contain details about such a study.

Here's what can be gathered, with caveats:

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

The document states: "Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."

It does not provide a specific table of acceptance criteria (e.g., specific energy output ranges, spot size tolerances) nor the numerical reported performance for each criterion. The general acceptance criterion was likely meeting predefined design specifications and demonstrating performance comparable to the predicate devices.

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. The "test set" was laboratory testing, not a clinical study with patient data.

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. Ground truth as typically understood in AI/ML medical devices (e.g., expert consensus on images, pathology results) is not relevant for this type of laboratory performance testing. "Ground truth" would likely refer to calibrated measurement equipment in the lab.

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

Not applicable. This concept applies to expert review of clinical cases.

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

No. This device is an ophthalmic laser for treatment (Selective Laser Trabeculoplasty), not a diagnostic device involving AI assistance for human readers.

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

No. This is a physical laser device, not an algorithm.

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

Not specified, but for laboratory testing, ground truth would be established by calibrated measurement tools and engineering standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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