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In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

All these devices consist of the below main parts: Delivery Head, Microscope and Slit lamp Illumination, Console and Table Top, Joystick fire button, Total solution table, Display unit.

This FDA 510(k) summary does not contain the information required to populate a table of acceptance criteria and reported device performance related to clinical effectiveness. This submission is for an ophthalmic laser system (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo) and the FDA has determined that clinical data is not required because the new devices use the same technology and principles as a previously cleared predicate device (Ellex YAG/SLT, K212630).

Therefore, many of the requested fields cannot be filled. However, based on the non-clinical testing performed, we can infer some "acceptance criteria" related to safety and performance specifications, though not in the typical format of clinical outcomes.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical data was not required, there are no specific clinical acceptance criteria or reported clinical device performance metrics in this summary. The "acceptance criteria" are implied by compliance with various safety and performance standards for medical devices and lasers.

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

This information is not provided. As per Section IX, "clinical data is not required" for the substantial equivalence determination. The "tests" mentioned are non-clinical safety and performance tests against standards, not clinical studies with patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical ground truth was established for a test set in this submission.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a physical laser device, not a standalone algorithm.

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

Not applicable, as no clinical ground truth was established for a clinical study in this submission. For the non-clinical tests, the "ground truth" is adherence to international and federal safety and performance standards.

8. The sample size for the training set

Not applicable. No AI/ML component requiring a training set is mentioned.

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

Not applicable. No AI/ML component requiring a training set is mentioned.

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In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

The provided text is a 510(k) summary for the Ellex YAG/SLT Laser. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, or accuracy) or a multi-reader, multi-case comparative effectiveness study involving human readers and AI assistance.

The document states: "Since the Ellex YAG/SLT devices use the same technology and principles as the predicate device, clinical data is not required." This means that traditional clinical performance studies (like those that would establish detailed acceptance criteria for diagnostic accuracy or reader improvement) were not conducted or submitted for this 510(k) clearance. The focus of this submission is on demonstrating fundamental safety and technological equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study design, as this information is not present in the provided document.

The document primarily covers non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, and software verification/validation) to support the safety and substantial equivalence of the new device to the predicate device.

Key takeaway from the document: The applicant relied on substantial equivalence to a predicate device (Lumenis Selecta Duet, K021550) and extensive non-clinical testing to demonstrate the safety and effectiveness of the Ellex YAG/SLT Laser, rather than conducting new clinical performance studies with specific acceptance criteria that would assess diagnostic or treatment effectiveness in a quantitative manner.

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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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LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for:

• · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
• · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
• · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
• Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet
• age-related macular degeneration (wet AMD)- with Slitlamp
• · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp

LightLas 532/810 Multi-Wavelength Medical Laser System can emit 532 nm wavelength laser beam and 810 nm wavelength laser beam. The 532 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 810 nm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.
LightLas 532/810 Multi-Wavelength Medical Laser System is intended for use by ophthalmologists for treatment of ocular pathology, and the system consists of the following functional components:

• LCD touch panel ●
• Laser Console
• Ophthalmic Instrument table ●
• CSO Slitlamp SL980 (K992836) ●
• Endolaser probe (K133019)

The provided text describes a medical laser system, the LightLas 532/810, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study proving that the device meets specific performance criteria in a way that aligns with your request for AI/algorithm performance analysis.

The document focuses on demonstrating that the LightLas 532/810 is substantially equivalent to existing medical laser systems (Quantel Medical Supra Twin K081946 and LightMed Corporation LightLas 532/670 K103547). The "performance data" section primarily discusses bench testing, electrical safety, EMC, and software verification and validation, which are standard regulatory requirements for medical devices. These are not clinical studies evaluating the laser's therapeutic effectiveness against predefined metrics of success for patient outcomes or diagnostic accuracy.

Therefore, I cannot provide the information requested in your table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/algorithmic systems, which is not the subject of this document.

The document states: "The clinical evaluation data demonstrate that LightLas 532/810 Laser System performs comparably to the predicate devices which are currently marketed for the same intended use." However, it does not elaborate on what "clinical evaluation data" entails, what its methodology was, or what specific acceptance criteria were used for therapeutic outcome.

In summary, the provided text describes a traditional medical device (a laser system) and its regulatory review for substantial equivalence, not an AI or algorithmic device with performance criteria as you've outlined.

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The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:

• 1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy
• 2. Clinically Significant Macular edema
• 3. Choroidal neovascularization
• 4. Branch and central retinal vein occlusion
• 5. The treatment of choroidal neovascularization associated with wet age-related macular degeneration
• 6. Lattice degeneration
• 7. Retinal tears and detachments

LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table.
The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.
The LightMed TruScan 577 Laser System is comprised of the following functional components:

• LCD touch panel
• Laser Console ●
• Ophthalmic Instrument table
• TruScan integrated CSO Slitlamp (K992836)

The provided text describes a 510(k) premarket notification for the LightMed TruScan 577 Laser System, focusing on its substantial equivalence to a predicate device. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device evaluating images or data for diagnostic purposes, nor does it present acceptance criteria and reported device performance in the format of a table as requested for such a study.

Instead, this document focuses on demonstrating that the LightMed TruScan 577 Laser System, a medical device for ophthalmic photocoagulation, is substantially equivalent to a legally marketed predicate device (PASCAL Streamline 577). The "performance data" referred to in Section VII are primarily bench testing, electrical safety, EMC, and software verification/validation, which are typical for traditional medical device clearances, not for AI/ML performance evaluation against a dataset with ground truth.

Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be extracted from this document because it describes a different type of medical device and regulatory submission.

Here's an analysis of what can be inferred or is explicitly stated:

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

• Cannot be provided. The document does not define acceptance criteria and reported performance in the context of diagnostic accuracy, sensitivity, specificity, etc., against a ground truth dataset, as would be relevant for an AI/ML device. The performance data discussed are related to the device's physical and electrical functioning, not its ability to interpret medical images or data.

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/Not provided. No test set of patient data (e.g., images, clinical records) is described. The "test set" in this context refers to the device itself undergoing various engineering and safety tests.

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/Not provided. No ground truth for a test set of medical data is discussed.

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

• Not applicable/Not provided. No adjudication of medical data for ground truth is discussed.

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/Not provided. This is a laser system, not an AI/ML diagnostic aid for human readers. No MRMC study is mentioned.

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

• Not applicable/Not provided. This device is a treatment laser, operated by a human ophthalmologist. There is no "algorithm only" performance concept relevant here.

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

• Not applicable/Not provided. No ground truth for medical data is discussed. The "ground truth" for this device would be its adherence to engineering specifications and safety standards.

8. The sample size for the training set

• Not applicable/Not provided. No training set of medical data for an AI/ML algorithm is discussed.

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

• Not applicable/Not provided. No training set of medical data for an AI/ML algorithm is discussed.

Summary of relevant information from the document:

• Device Type: Ophthalmic Laser (LightMed TruScan 577 Laser System).
• Purpose: Treatment of ocular pathology in the posterior segment (e.g., retinal photocoagulation for diabetic retinopathy, macular edema, choroidal neovascularization).
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
• Predicate Device: PASCAL Streamline 577 (K111108).
• Performance Data Provided:
  • Bench Testing (Finished Product final assembly quality inspection, System Adjustment, Calibration and Testing for Laser console and TruScan laser delivery unit).
  • Electrical safety and electromagnetic compatibility (EMC) testing, complying with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.
  • Software Verification and Validation Testing, considering the software as a "major" level of concern.
• Conclusion: The non-clinical data (bench testing, electrical safety, EMC, software V&V) supported the safety and intended performance, demonstrating comparability to the predicate device.

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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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LightLas 577/670 is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation. endophotocoagulation, macular photocoagulation to treat leaking vessels. and laser trabeculoplasty. The 670 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation.

LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: Slitlamp Integrated into CSO model SL980. (K992836) . Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. . Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ● . Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0 . Endophotocoagulation Handpieces (K122905) The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.

The provided text describes a 510(k) summary for the LightLas577/670 Multi-Wavelength Medical Laser System. This document focuses on demonstrating substantial equivalence to a predicate device through technical comparison and compliance with recognized standards. It does not contain information about clinical studies with acceptance criteria or reported device performance in those terms.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

However, based on the provided text, here's what I can extract regarding the study information (or lack thereof):

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not describe specific acceptance criteria tied to clinical performance metrics (e.g., sensitivity, specificity, accuracy) or present reported device performance against such criteria. The "Performance Data" section indicates compliance with recognized standards (IEC, ISO) and successful bench testing, which are engineering/safety criteria, not clinical performance metrics.

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

• No information provided. The document does not refer to a "test set" in the context of clinical data, nor does it mention sample sizes or data provenance (country of origin, retrospective/prospective). The "test results" mentioned refer to bench testing.

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

• No information provided. Since no clinical test set is described, there's no mention of experts or expert consensus for ground truth.

4. Adjudication Method:

• No information provided. No clinical test set means no adjudication method is mentioned.

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

• No MRMC study was done or reported. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a laser system, not an AI algorithm. "Standalone performance" as typically applied to algorithms is not relevant here.

7. Type of Ground Truth Used:

• Not applicable. For the bench testing mentioned, ground truth would be established by validated measurement equipment and engineering standards, not clinical outcomes or pathology.

8. Sample Size for the Training Set:

• Not applicable. This device is a laser system and does not involve AI models that require training sets.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set for an AI model.

Summary of Device Evaluation from the Text:

The device's safety and effectiveness were evaluated through:

• Bench testing: This involved assembly, testing, calibration, and alignment of the laser console and delivery units. The results demonstrated compliance with specifications and requirements.
• Compliance with recognized consensus standards: IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22, and ISO14971.

The conclusion drawn from this evaluation was that the "LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device." This statement refers to demonstrating substantial equivalence to the predicate device (K103547) based on technical characteristics, intended use, and compliance with general safety and performance standards for ophthalmic lasers, rather than presenting a clinical study with performance metrics against acceptance criteria.

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