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Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.

Vortex Surgical Illuminated Laser Probe is a sterile, single used for delivering laser endophotocoagulation with illumination into the posterior segment of the eye.

Vortex Surgical Laser Probe is a sterile, single use medical device used for delivery laser endophotocoagulation into the posterior segment of the eye.

The laser probe is a cable made fiberoptic, one laser connector, one handle for surgeon manipulation, nitinol, PEEK, or stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. The MAXReach model device also contains a slide button allowing the surgeon to bend the nitinol, PEEK, or stainless steel tubing once inside the eye to direct output into the periphery of the eye. On the proximal end the fiberoptic is terminated by a connector that attaches to the distal side, the fiberoptic is terminated by nitinol, PEEK, or stainless steel tubing which penetrates the eye. The probe can be either 23ga, 25ga, or 27ga. The fiber for laser transmission is made from silica glass and is restricted for use with the wavelength of 500nm to 1100mm. In illuminated laser probes, the illumination fiber is made of PMMA. The total length of the device is 90 ± 6 inches.

Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye.

The endoilluminator is an illuminators made from one fiber optic cable, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and the protective sheath over the fiber. On the proximal side the fiberoptic is terminated by a connector that attaches to the illumination console. The endoilluminator utilizes a needle. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The chandelier is an illuminator made from one fiber optic cable and the protective sheath over the fiber. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.

The provided text describes a 510(k) premarket notification for Vortex Surgical's Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers. As a medical device submission, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving novel clinical efficacy or conducting a multi-reader multi-case (MRMC) study. Therefore, the details requested in points 5, 8, and 9 (related to AI-assisted human reader improvement, training set size, and training set ground truth establishment) are not applicable in this context, as the device is not an AI/ML software or diagnostic tool that requires such studies.

Here's an analysis based on the information provided for the other points:

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

The document does not present explicit "acceptance criteria" in a table format with specific quantitative thresholds. Instead, the performance evaluation focuses on demonstrating that the subject devices are substantially equivalent to their predicates across various non-clinical bench tests and material assessments. The criteria are implicitly met if the test results show equivalence and do not raise new safety or effectiveness concerns.

The document concludes: "The performance of the Vortex Surgical Laser Probes, Illuminated Laser Probes, Endoilluminators, and Chandeliers show that the instruments are substantially equivalent to their predicates. Vortex Surgical had demonstrated through Ethylene Oxide (EO) sterilization EU residual testing, endotoxin testing, biocompatibility testing, shelf-life testing, and nonclinical bench test results that the Vortex Surgical instruments are safe and effective as their predicate devices and any difference between the two raise of safety or effectiveness."

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

The document does not specify a "sample size" in terms of number of patients or cases. The tests described are primarily non-clinical bench tests (e.g., laser output, mechanical actuation, biocompatibility assessments) and material characterization. Therefore, the data provenance is from laboratory testing of the devices themselves, not from patient data. There is no indication of country of origin for such non-clinical test data, nor is it classified as retrospective or prospective in the clinical sense.

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

This question is not applicable as the device is not a diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering specifications, recognized standards (e.g., IEC 60601-2-22, ANSI Z80.36-2016, ISO 10993-1, ISO 11135), and the performance characteristics of the predicate device.

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

This point is not applicable as there is no human interpretation or subjective assessment of data that would require an adjudication method. The testing involves objective, measurable physical and chemical properties and performance characteristics against established standards or predicate device performance.

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 is not applicable. The device is not an AI-assisted diagnostic tool. It is a surgical instrument (laser probes, illuminators). MRMC studies are typically performed for diagnostic devices, especially those incorporating AI, to evaluate human reader performance with and without AI assistance. This document describes a submission for a substantially equivalent predicate device, not an AI-powered one.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm. Standalone performance evaluation (without human-in-the-loop) would refer to the performance of a software algorithm on its own, which is not relevant here.

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

As explained in point 3, the "ground truth" for this type of device and submission is based on engineering specifications, recognized international standards (e.g., ISO, IEC, ANSI), and the established performance characteristics of the predicate device. For biocompatibility, it's about meeting the safety thresholds defined by ISO 10993-1. For performance, it's about meeting the requirements of electro-optical and mechanical standards and demonstrating equivalence to a legally marketed predicate. There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus on interpretations.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

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

This question is not applicable. The device is not an AI/ML model, so there is no "training set" or ground truth establishment for such a set.

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MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser

MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.

The provided text is a 510(k) summary for the Vortex Surgical MAXReach Laser Probe. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information related to software-driven device performance, clinical study acceptance criteria, or a study proving device performance against such criteria.

The document primarily focuses on:

• Regulatory information: 510(k) number, regulation details, classification, and general controls.
• Device description: Physical characteristics, materials, and compatibility with laser systems.
• Comparison to a predicate device: Highlighting similarities in indications for use, intended use, wavelength, optical fiber, and other technical characteristics.
• Non-clinical bench testing: This testing involved laser output, laser spot size, laser compatibility, ophthalmic cannula interface, and handle actuation testing. The conclusion states these tests indicate the device operates similarly to the predicate and is safe and effective.
• Risk management: Compliance with ISO 14971.
• Biocompatibility, sterilization, and shelf-life testing.

Therefore, I cannot provide the requested table of acceptance criteria and study details because the provided text does not describe a study proving the device meets acceptance criteria. The document focuses on showing substantial equivalence to a predicate device through engineering and bench testing, not through a clinical performance study with human subjects, which would typically involve the type of acceptance criteria and study design elements you've asked about.

The "study" referenced in the text is "Non-Clinical Bench Testing," which is distinct from a clinical study assessing reader performance.

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VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.

The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.

The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application.

The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery.

The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip.

To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens.

The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for singleuse only.

The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm.

For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application.

The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available.

The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.

This document is a 510(k) Pre-Market Notification from Vitreq B.V. for their Disposable Laser Probes, Light Fibers, and Chandelier. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

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

The document doesn't explicitly present a formal "acceptance criteria" table with corresponding numerical performance results in the format requested. Instead, it describes performance characteristics and compares them to the predicate device, emphasizing substantial equivalence.

Based on the "Summary of technological characteristics" and "Differences in performance" sections, we can infer some performance metrics and their comparison:

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

The document does not provide explicit sample sizes for any specific test sets for performance. It mentions "Performance Testing Summary" indicating that the devices "have been tested to meet the product requirements and requirements from (safety) standards," covering "performance testing and human factors testing." However, details on the methodology, sample sizes, and specific data provenance (country, retrospective/prospective) are not provided in this public summary.

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):

This information is not available in the provided document. The document describes a medical device (laser probes and light fibers) for surgical use, not an AI/diagnostic device that typically involves expert ground truth establishment for test sets.

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

This information is not applicable or not available in the provided context. Adjudication methods are typically relevant for diagnostic studies where expert disagreement on ground truth occurs. This document focuses on the physical and functional performance of a surgical instrument.

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 as the device described is a physical surgical tool (laser probes and light fibers), not an AI-assisted diagnostic or decision support system that would involve human readers or AI assistance.

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

This information is not applicable as the device is a physical surgical tool, not an algorithm or software-only device.

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

For the performance testing mentioned (e.g., laser transmission, power output, light transmission, biocompatibility), the "ground truth" would be established by well-defined engineering specifications, international standards (e.g., ISO, ANSI), and validated testing methodologies against which the device's physical and functional properties are measured. It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic AI device would.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical instrument, not an AI model that requires a training set.

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

This information is not applicable as the device is a physical medical instrument, not an AI model.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources.

The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm.

The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device.

The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.

Here's a breakdown of the acceptance criteria and study information for the Peregrine 25ga Curved Illuminating Laser Probe, based on the provided text:

Device: Peregrine 25ga Curved Illuminating Laser Probe (PD725.37SA)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly derived from the comparison to the predicate device and the successful completion of performance tests. The goal was to demonstrate substantial equivalence, meaning the new device performs at least as safely and effectively as the predicate.

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

The document does not explicitly state a "test set" in the context of human data or a specific number of devices tested for each performance characteristic. Instead, it refers to:

• "3 performance tests" to evaluate light output, laser power output, and laser field clarity. The sample size for these tests is not specified.
• "Bend testing" performed on both the existing and proposed designs. The number of samples for bend testing is not specified.
• Biocompatibility testing. The number of material samples tested is not specified.
• Sterilization and shelf-life validation. This would involve a specific number of packages/devices, but the exact count is not given.

The data provenance is Peregrine Surgical Ltd. internal testing. The document does not specify country of origin for test data, nor does it explicitly state if it was retrospective or prospective, though performance and material testing are typically prospective.

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

Not applicable. The document describes engineering and material performance testing rather than studies involving expert human review of medical images or diagnoses. The "ground truth" here is based on measurable physical properties and compliance with established material and manufacturing standards.

4. Adjudication method for the test set

Not applicable. This type of adjudication (e.g., 2+1, 3+1) is relevant for studies where human experts interpret data (like images) and resolve discrepancies. The provided document details technical performance and material testing.

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 device is a surgical tool (laser probe), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

Yes, in essence, standalone performance tests were done. The "3 performance tests" (light output, laser power output, laser field clarity), "bend testing," and biocompatibility testing represent the standalone performance evaluation of the device itself, without human interpretation in a diagnostic context. The device's function is to transmit laser and light energy, and these tests evaluate that function directly.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

• Physical measurements and engineering specifications: Metrics like laser power efficiency, spot size, fiber dimensions, length, weight, etc., are directly measured and compared against the predicate device's established performance parameters.
• Material standards: Biocompatibility is assessed against established biological safety standards. Nitinol's use is justified by its existing approval in other ophthalmic devices and by specific bend testing.
• Sterilization and shelf-life validation standards: Compliance with AAMI Overkill Method according to ISO 11135-1 and residual testing.

8. The sample size for the training set

Not applicable. This device's development and evaluation do not involve machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.

The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).

It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
   • Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.

2. 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 in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
   • The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.

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

   • Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.

4. 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 physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.

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

   • The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.

7. The sample size for the training set

   • Not applicable. This is a physical device, not an AI-based system requiring a training set.

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

   • Not applicable given that no training set was used.

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The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.

The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana.

The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.

The provided text describes a 510(k) submission for the Synergetics Disposable Directional Endo Ocular Laser Probe. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, complex AI/software-driven device.

Therefore, much of the requested information regarding AI device testing (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided:

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

The "acceptance criteria" for this conventional device are primarily based on demonstrating substantial equivalence to a predicate device (Gamp and Associates Disposable Endoocular Laser Probe, K954307) across key technical characteristics and intended use. The "reported device performance" is the direct comparison of these characteristics.

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

The submission indicates "Bench testing, and comparative performance testing to the predicate device, was performed." This refers to physical, non-clinical tests on the device itself.

• Sample Size: Not explicitly stated, but typically involves a number of manufactured units of the device. This is not patient or image data.
• Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer, Synergetics, Inc., likely at their facilities or a contracted testing lab.

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. This is not a diagnostic AI device requiring expert-established ground truth from medical images or patient data. The "ground truth" here would be the physical properties and performance measurements of the device itself (e.g., laser power output, sterility, packaging integrity).

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

Not applicable, as this is not a diagnostic AI device or clinical study involving expert interpretation with adjudication.

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 traditional surgical device, not an AI software.

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

Not applicable. This is a traditional surgical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be established through a series of engineering and physical measurements against predefined specifications and industry standards, as well as comparison to the predicate device's known characteristics. Examples include:

• Laser power transmission efficiency
• Fiber integrity and durability
• Sterility (validated to AAMI/ISO 11135)
• Packaging integrity (validated to ISO 11607-1:2006)
• Biocompatibility (if applicable, though not explicitly detailed here)
• Mechanical strength and component integrity

8. The sample size for the training set

Not applicable. This is a traditional hardware medical device, not an AI model requiring a training set.

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

Not applicable.

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The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:

27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.)

27+ Flex-Tip Laser Probe: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.)

27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System)

27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae)

27+ Infusion Cannula: Posterior segment infusion (liquid or gas)

The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.

The Alcon Research, Ltd. 27+ Retina Instrument Set is a set of surgical instruments intended for ophthalmic procedures, specifically vitreoretinal surgery. The devices are modified versions of existing, larger gauge instruments with smaller diameter tips for less invasive surgery. This 510(k) summary focuses on demonstrating substantial equivalence to these predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format requested. Instead, the submission demonstrates equivalence through a combination of:

• Biocompatibility Standards Compliance: The materials are evaluated against a comprehensive set of ISO 10993 standards.
• Sterilization Validation: The ethylene oxide (EO) sterilization process is validated to a Sterility Assurance Level (SAL) of 10^-6, compliant with EN ISO 11135-1:2007.
• Technological Characteristics Equivalence: The claim is that the "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The 27+ Retina Instrument Set has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices."

Since no specific numerical acceptance criteria or performance results are provided, a table in the requested format cannot be created. The "performance" is demonstrated by adherence to technical standards and the claim of substantial equivalence to predicate devices.

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

The document describes non-clinical testing for biocompatibility and sterilization.

• Sample Size for Test Set: Not specified. The document states that "Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed" and "EO sterilized and the process has been validated." The specific number of samples for each test (e.g., cytotoxicity, irritation, systemic toxicity) is not disclosed in this summary.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to international standards (ISO, AAMI/ANSI, EN ISO). The country of origin for the data is not explicitly stated beyond being conducted by Alcon Research, Ltd. There is no indication of retrospective or prospective patient data, as this is a pre-market submission for a surgical instrument rather than a diagnostic AI device.

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

This information is not applicable. The "ground truth" in this context refers to established scientific and regulatory standards for biocompatibility and sterilization, which are inherently defined by consensus among scientific and medical experts who developed these international standards (ISO, AAMI/ANSI, EN ISO). There are no "experts" establishing ground truth for this specific device's test set in the way one would for annotating medical images for an AI algorithm. The device's materials and sterilization process are evaluated against predefined criteria outlined in the standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving disagreements in expert labeling of ground truth data, especially in studies involving human interpretation (e.g., reading medical images). Here, the testing involves standardized laboratory methods and measurements against established criteria, not subjective expert judgment that requires adjudication.

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 is not applicable. The submission is for a surgical instrument set, not an AI or diagnostic imaging device that involves human readers or AI assistance. No MRMC study was performed or is relevant to this type of device.

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

This is not applicable. The device is a set of physical surgical instruments, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on:

• Established Biocompatibility Standards: The test results are compared against the acceptance criteria defined within ISO 10993 series standards, which represent expert consensus on biological evaluation of medical devices.
• Sterilization Validation Standards: The sterilization process is validated against EN ISO 11135-1:2007, a standard for ethylene oxide sterilization, representing expert consensus on achieving sterility.

There is no "pathology" or "outcomes data" in the typical sense for proving the fundamental safety aspects covered in this non-clinical testing.

8. The Sample Size for the Training Set

This is not applicable. There is no AI algorithm being developed or "trained" for this surgical instrument set.

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

This is not applicable as there is no training set for an AI algorithm.

Ask a specific question about this device

Ask a specific question about this device

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.

The provided text describes a 510(k) summary for the Nidek Multicolor Laser Photocoagulator System MC-500. This summary focuses on establishing substantial equivalence to a predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300, K042785) through bench testing.

Based on the provided information, here's a breakdown regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide a table of performance metrics. The assessment relies on a qualitative determination of "substantial equivalence" to a predicate device.

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

No specific "test set" in terms of patient data or clinical samples is mentioned. The testing conducted was "bench testing." Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable as it was not a clinical study.

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

As no clinical test set was used, there were no experts involved in establishing ground truth for such a set based on the provided information. The evaluation was focused on technical performance and equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No MRMC study was performed or mentioned. The submission is based on bench testing to establish substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable, as this device is a laser photocoagulator system, not an AI algorithm. Its performance is evaluated based on its technical specifications and functional equivalence.

7. Type of Ground Truth Used:

The "ground truth" for the substantial equivalence determination was the performance and characteristics of the predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300). The MC-500's performance was compared to the established performance of the legally marketed predicate device through bench testing.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device (laser system), not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

In summary, the provided document details a 510(k) submission for a medical device (a laser photocoagulator system) where substantial equivalence was demonstrated through bench testing against a predicate device. It does not involve AI, clinical efficacy studies with patient data, or expert-adjudicated ground truth as would be relevant for an AI/ML medical device.

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