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The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as:

• Photocoagulation of the retina .
• t Trabeculoplasty for treatment of glaucoma
• . Iridotomy for treatment of glaucoma.

The VISULAS Trion Laser System with the VITE option is intended for use in multispot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:

• Proliferative and nonproliferative diabetic retinopathy .
• . Macular edema
• . Branch and central retinal vein occlusion
• Lattice degeneration .
• . Retinal tears and detachments
• Choroidal neovascularization associated with wet age-related macular . degeneration.

The VISULAS Trion Laser System with the VITE option is a multi-wavelength ophthalmic surgical laser intended for use in the photocoagulation of ocular tissues in treatment of diseases of the eye.
Similar to the predicate device, the VISULAS Trion Laser System (K072514) laser, energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery.
The VISULAS Trion Laser System with the VITE option includes a modified laser slit lamp (LSL) that features a multi-spot treatment cascade delivery option. The modified LSL is identical to the LSL offered with the predicate device, the VISULAS 532s Laser System with the VITE option (K100035), also manufactured by Carl Zeiss Meditec.

This 510(k) summary (K103056) describes the VISULAS Trion Laser System with the VITE option. This device is an ophthalmic surgical laser intended for photocoagulation of ocular tissues. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria with numerical targets for device performance during non-clinical testing. Instead, it refers to general functional equivalence and comparability to predicate devices.

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

The document describes non-clinical tests and results but does not specify the sample size or details of the test set data. It mentions "performance data conducted using the VISULAS Trion with the VITE option."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are described as non-clinical.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of non-clinical testing typically involves engineering and functional validation against standards rather than expert-derived ground truth.

• Number of Experts: Not applicable/Not mentioned.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

Since no expert ground truth or assessment of a test set by multiple readers is described, an adjudication method is not applicable or mentioned.

• Adjudication Method: Not applicable/Not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The submission relies on non-clinical engineering and functional comparability to predicate devices.

• MRMC Study: No.
• Effect Size with AI vs. without AI: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study was performed.

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

This device is an ophthalmic surgical laser, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's operation inherently involves a human laser surgeon.

• Standalone Performance: Not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" (if applicable in this context) would be defined by engineering specifications, applicable medical device standards, and the functional output of the predicate devices. The text states it demonstrates the "ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate devices," implying a comparison to the established performance of the predicate devices.

• Type of Ground Truth: Engineering specifications, compliance with applicable standards, and functional comparability to predicate devices.

8. The Sample Size for the Training Set

This submission describes a medical device (a laser system), not a machine learning model. Therefore, the concept of a "training set" is not applicable.

• Sample Size for Training Set: Not applicable.

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

As this is not a machine learning device, the concept of a "training set" and establishing "ground truth for the training set" is not applicable.

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The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:

• Photocoagulation of the retina .
• Trabeculoplasty for treatment of glaucoma .
• Iridotomy for treatment of glaucoma. .

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

The VISULAS Trion is a diode-pumped, solid state, three-color laser system for green, yellow and red wavelengths, based upon the predicate VISULAS 532s (K013402). The VISULAS Trion laser system consists of the following components: Laser console as the source of laser radiation with detachable operating control panel, two fiber ports for application devices and a foot switch. Application devices for laser radiation delivery are offered via either transpupillary or intraocular delivery, laser slit lamp, laser indirect ophthalmoscope and endoprobes.

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. Medical device 510(k) summaries typically focus on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner requested.

However, based on the information provided, here's what can be gathered or inferred about the device's intended use and the nature of the evaluation for substantial equivalence:

Device Information (VISULAS Trion)

• Intended Use: Photocoagulation of ocular tissues for the treatment of diseases of the eye, including:
  • Photocoagulation of the retina
  • Trabeculoplasty for treatment of glaucoma
  • Iridotomy for treatment of glaucoma
• Operating Principle: Diode-pumped, solid-state, three-color laser system (green, yellow, red wavelengths).
• Predicate Device: VISULAS 532s (K013402) by Carl Zeiss Meditec AG, among others.

Inferred Acceptance Criteria and Study Information (Based on 510(k) Process)

Since direct acceptance criteria and detailed study results are not presented in this 510(k) summary, the following sections will be largely speculative or based on the common practices for establishing substantial equivalence for devices like the VISULAS Trion.

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred): For a laser photocoagulator, acceptance criteria would typically revolve around meeting established safety standards (e.g., IEC 60601-2-22 for medical laser equipment) and demonstrating equivalent performance characteristics to the predicate devices. These characteristics would likely include:

  • Wavelength accuracy and stability
  • Output power accuracy and stability
  • Spot size accuracy and consistency
  • Pulse duration accuracy and consistency
  • Beam quality (e.g., divergence)
  • Safety features (e.g., interlocks, emergency stop)
  • biocompatibility of patient-contacting parts
  • Electrical safety and electromagnetic compatibility (EMC)
  • Reliability and durability
  • Clinical effectiveness equivalent to predicate devices for the stated indications.

• Reported Device Performance: The summary states: "Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness." This indicates that the device's performance, as evaluated against the predicate devices and relevant standards, met the criteria for substantial equivalence. No specific quantitative performance metrics are provided in this summary.

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

• Sample Size: Not explicitly stated. For substantial equivalence of a physical medical device like a laser, the "test set" would typically refer to the number of devices or components tested. This could involve bench testing, engineering verification, and potentially limited clinical data if necessary to address specific equivalence questions. However, the summary doesn't detail these numbers.
• Data Provenance: The device manufacturer, Carl Zeiss Meditec AG, is based in Jena, Germany. Testing would likely have been conducted by the manufacturer, possibly at their facilities or through authorized testing houses. The nature of the submission (510(k)) and the device type (laser system) suggests that a significant portion of the data would be from bench testing and engineering verification/validation, rather than large-scale clinical trials in the way one might expect for a diagnostic AI device. Clinical data, if any, would likely be limited to demonstrate consistency with the predicate. It's not specified if data was retrospective or prospective beyond the internal testing.

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

• This question is more applicable to diagnostic devices where human expert interpretation is crucial for ground truth. For a therapeutic laser device like the VISULAS Trion, "ground truth" would be established through objective physical measurements (e.g., power meters, beam profilers, spectrometers) and engineering validation against established specifications and predicate device performance. Clinical ground truth, if involved, would be based on established medical success criteria for the procedures (e.g., successful photocoagulation, IOP reduction post-trabeculoplasty), but the role of "experts establishing ground truth for a test set" in the context of substantial equivalence of the device's performance directly is not typically structured in this way.

4. Adjudication Method for the Test Set

• Not applicable in the typical sense for a therapeutic device's performance validation for substantial equivalence. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies for diagnostic accuracy involving human readers. For the VISULAS Trion, performance is determined by objective physical measurements and engineering validation, not subjective expert agreement on a diagnosis.

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

• No, an MRMC study was NOT done. MRMC studies are specifically designed to evaluate the diagnostic accuracy of a new method/device (often AI) compared to human readers, and how human performance changes when aided by the device, usually with imaging data. The VISULAS Trion is a therapeutic laser, not a diagnostic imaging AI device. Its effectiveness is based on its ability to deliver precise laser energy for photocoagulation.

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

• Not applicable. The VISULAS Trion is a therapeutic laser system operated by a human clinician. It does not consist of a standalone "algorithm" in the way an AI diagnostic device would. Its performance is inherent in its engineering and physical output, which is then used by a human operator.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the VISULAS Trion's performance would primarily be objective physical measurements and engineering standards. This would include:
  • Metrology: Using calibrated instruments to measure laser power, wavelength, spot size, pulse duration, and beam quality.
  • Safety Standards: Compliance with international and national safety standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825 series).
  • Predicate Device Performance Data: Direct comparison of critical performance parameters against those of the legally marketed predicate devices.
  • Biocompatibility Testing: For patient-contacting components.
  • Functional Testing: To ensure all operational modes and safety features work as designed.
• "Pathology" or "outcomes data" might be part of post-market surveillance or larger clinical trials, but for a 510(k) of this nature, the primary ground truth for device performance is technical and engineering-based.

8. The Sample Size for the Training Set

• Not applicable. The VISULAS Trion is a hardware-based medical device, not an AI or machine learning algorithm that requires a "training set" of data. Its design and development would involve engineering prototypes, design iterations, and testing, but not a data training set.

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

• Not applicable for the same reason as point 8.

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