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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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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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Ophthalmology:
532nm Laser

• Retinal Photocoagulation
• Pan Retinal Photocoagulation
• Endophotocoagulation
• Macular photocoagulation to treat leaking vessels
• Laser Trabeculoplasty
  670nm Laser
• Retinal/Pan Retinal Photocoagulation
  The intended use has not changed from the predicate devices (K052777, K022181, K042785, and K091534)

The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength 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.
• Slitlamp Attachment for CSO model SL990 and other Haag Streit clones.
• Slitlamp Attachment for Zeiss model SL30 Slitlamp.
• Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
• Endophotocoagulation handpieces (Endoprobes).

This submission describes a medical laser system and focuses on its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information cannot be directly extracted from the provided text.

Here is an analysis based on the available information:

Key Takeaway: The submission for the LightLas Multi-Wavelength Medical Laser System (LightLas 532/670) focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through a novel study. This means the device's performance is inferred to be similar to legally marketed devices based on shared technological characteristics and intended use, not through a separate quantitative performance study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This submission is for a physical medical laser device, not a software or AI device that would typically use a test set of data. The "testing" mentioned refers to engineering and safety performance of the hardware.

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

• Not applicable / Not provided. As above, this is not a data-driven AI/software device. The "ground truth" here is the established safety and effectiveness of the predicate devices in clinical practice, as recognized by the FDA through their previous clearances.

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

• Not applicable / Not provided. No specific test set with human adjudication is mentioned.

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 is not an AI-assisted diagnostic or therapeutic device that involves "human readers" in the sense of interpreting medical images or data. It is a direct medical laser system for ophthalmic procedures.

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

• Not applicable / Not provided. This is not an algorithm-only device.

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

• Indirect Ground Truth: Clinical Efficacy and Safety of Predicate Devices. The "ground truth" for this substantial equivalence claim is the well-established safety and efficacy of the predicate devices. The new device is deemed equivalent because its technological characteristics and intended use are the same, implying it will perform in a clinically similar and safe manner.

8. The sample size for the training set:

• Not applicable / Not provided. There is no mention of a training set as this is not a machine learning/AI device.

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

• Not applicable / Not provided.

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The LightLas 577 Medical Optical Pumped Semiconductor Laser is intended for use in ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

• . Retinal Photocoagulation
• Pan Retinal Photocoagulation .
• Endophotocoagulation ●
• Macular Photocoagulation
• Laser Trabeculoplasty (to treat Open Angle Glaucoma)

The LightLas 577 Laser beam has a wavelength of 577mm, which is in the visible spectrum and is a Yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The LightLas 577 is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 577nm.

LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 577 retinal photocoagulator to allow use of the slit lamp to deliver 577 nm continuous wave laser energy for retinal photocoagulation.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

I am sorry, but the provided text does not contain the detailed information necessary to complete the request regarding acceptance criteria and study data for the LightLas 577 Medical Optical Pumped Semiconductor Laser.

The text is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices and regulatory compliance.

Here's what is missing from the provided text that would be needed to answer your questions:

• Specific Acceptance Criteria: The document states "The appropriate testing including safety, performance and functional testing to determine The appropriate testing methoding Laser System." but it does not list what those acceptance criteria were for performance metrics.
• Reported Device Performance: While it mentions testing was done, it does not provide any quantitative results or data on the device's performance against any specific metrics.
• Details of the Study: There is no description of any specific study (clinical, standalone, or MRMC) that was conducted to prove the device meets acceptance criteria.
  • No information on sample sizes (test set, training set).
  • No data provenance (country, retrospective/prospective).
  • No number of experts, their qualifications, or adjudication methods for ground truth.
  • No mention of MRMC comparative effectiveness or effect sizes.
  • No indication of a standalone performance study.
  • No type of ground truth used (pathology, outcomes, etc.) for any potential study.
  • No information on how ground truth was established for a training set.

The document primarily focuses on:

• Device description and intended use.
• Technological characteristics and comparison to predicate devices for substantial equivalence.
• Regulatory classifications and standards met.
• FDA's clearance decision.

Therefore, I cannot generate the requested table or answer the specific questions about the study design and results from the provided input.

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The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

• Retinal Photocoagulation .
• Pan Retinal Photocoagulation
• Endophotocoagulation
• Macular Treatments
• Laser Trabeculoplasty

Otolaryngology:

• Stapedectomy
• · Stapedotomy
• · Myringotomy
• · Lysis of adhesions
• Control of bleeding
• · Removal of acoustic neuromas ·
• · Soft tissue adhesion in micro/macro otologic procedures.

Dermatology:

• · Vascular lesion
• · Pigmented lesion

The intended use has not changed from the predicate devices (K022327, K020071, K062369)

The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

The provided text is a 510(k) summary for a medical device (Medical Frequency Doubled YAG Laser, Trade Name: LightLas 532). It focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states:

• "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Medical Frequency Doubled Y AG Laser System."
• "The LightLas 532 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation. laser trabeculoplasty. the treatment of vascular and pigmented skin lesions, and other laser treatments."

This indicates that the submission relies on demonstrating that the new device has "similar functional elements" and "same indications for use" as already cleared devices, and that it has undergone standard safety and functional testing, rather than an effectiveness study proving performance against specific quantitative acceptance criteria for accuracy, sensitivity, or specificity.

In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and study details.

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LightLas Lpulsa SYL-9000: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy and pupillary membranectomy. LightLas SeLecTor Deux: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. LightLas LaserLink : Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section. LightLas SecLeTor Trois: (SeLecTor Deux with LightLas 532 or 561 or 810) Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, and pupillary membranectomy, retinal photocoagulation and selective laser trabeculoplasty. The intended use has not changed from the predicate devices (K081704)

The LightLas Family of Medical Laser System is a fully integrated, high-performance diagnostic slitlamp and therapeutic laser delivery system. The System is also an ophthalmic surgical laser designed for performing photodisruption and photocoagulation. For ocular tissue using laser energy emitted by a Nd: YAG laser including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. The LightLas Family of Medical Laser System produces short, individual pulses of focused laser light with wavelengths of either 1064nm to 532nm, depending on the selected operational mode. Using a slitlamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye. There are several packages for treatment selectable. The LightLas Family of Ophthalmic Lasers is comprised of: LightLas Lpulsa SYL-9000 (K990075): A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy and pupillary membranectomy). LightLas SeLecTor Deux: A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption or frequency doubled YAG laser pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending on the mode selected. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532/561/810 retinal photocoagulator to allow use of the slit lamp to deliver 532/561/810 nm continuous wave laser energy for retinal photocoagulation. LightLas SeLecTor Trois: A Nd:YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption, Frequency Doubled YAG Laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected. The Trois is a LighLas SeLecTor Deux with one of LightLas system. LightLas SeLecTor Trois suitable for follow unit: 1. LightLas 532 : K010372 2. LightLas 561: K063297 3. LightLas 810: K021538

The provided text is a 510(k) summary for the LightLas Family of Medical Laser System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.

Therefore, the input document does not contain the information requested to fill out a table of acceptance criteria and reported device performance based on a study, nor does it provide details about such a study.

Here's what can be inferred from the document regarding a "study":

• No specific clinical study is described. The document states, "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas Family of Medical Laser System." This phrase indicates that engineering and bench testing were performed to demonstrate that the new device performs similarly to predicate devices, adhering to established performance standards (21 CFR 1040.10 & 1040.11). It does not mention a clinical trial or a study designed to evaluate specific performance metrics against pre-defined acceptance criteria in a patient population.
• Focus on Substantial Equivalence: The core of a 510(k) submission is to prove that the new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing technological characteristics and intended uses, and sometimes non-clinical performance data, rather than conducting new clinical trials with acceptance criteria for clinical outcomes.

Therefore, I cannot generate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided 510(k) summary.

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The indications of use for this device are:

• Retinal Photocoagulation
• Pan Retinal Photocoagulation
• Macular Photocoagulation
• Laser Trabeculoplasty
• Laser trabeculoplasty is photocoagulation of trabecular meshwork to treat Open Angle Glaucoma (OAG).
• Endocoagulation

Not Found

This looks like a 510(k) clearance letter for the LightLas 561 Ophthalmic Photocoagulator Laser. This kind of document typically does not contain the detailed study information you are asking for, as 510(k) applications demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial data on device performance against acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and lists its "Indications for Use." It does not provide performance metrics or details of studies used to demonstrate specific performance against acceptance criteria for an AI/ML device. The device is a "Photocoagulator Laser," which is a physical medical device, not a software-based diagnostic or AI/ML product that would typically involve the kind of performance metrics and study design you're asking about (e.g., ground truth, reader studies, test/training sets for algorithms).

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The LightLas 810 Infrared Laser Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The LightLas 810 is used in combination with various delivery systems, such as slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.

Not Found

This document is a 510(k) clearance letter for the LightLas 810 Infrared Laser Photocoagulator. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain the detailed information necessary to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

The provided text is a regulatory clearance document from the FDA, which confirms that a medical device (LightLas 810 Infrared Laser Photocoagulator) has been determined to be substantially equivalent to an already legally marketed device (a predicate device). This process is based on comparing the new device's features, indications for use, and technological characteristics to the predicate.

Such a document typically doesn't include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for a specific study proving performance.
• Information on expert adjudication, MRMC studies, or standalone algorithm performance.
• Training set details or how their ground truth was established.

These kinds of details are usually found in the technical documentation submitted by the manufacturer to the FDA (e.g., in engineering reports, clinical trial summaries, or validation studies), not in the 510(k) clearance letter itself. The clearance letter is the FDA's decision based on its review of that documentation.

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