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510(k) Data Aggregation
(269 days)
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
- · Posterior capsulotomy
· Posterior membranectomy
This device is Prescription Use (Rx) only.
VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:
- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -
VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.
The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.
However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.
| Criteria Category | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VISULAS combi) |
|---|---|---|
| Indications for Use | Same as predicate devices | - Photocoagulation of the retina- Trabeculoplasty- Iridotomy- Posterior capsulotomy- Posterior membranectomy (combines indications of both predicates) |
| Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled- Photodisruption: Q-switched Nd:YAG laser |
| Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm- Photodisruption: 1064 nm |
| Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW- Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJPulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJPulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
| Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation) < 4 ns (photodisruption) | - Photocoagulation: 10 - 2500 ms and cw- Photodisruption: < 4 ns |
| Laser Spot Size | 50 μm to 1000 μm (photocoagulation) 6.5 µm ± 20% in air (photodisruption) | - Photocoagulation: 50 μm to 1000 μm (continuously adjustable)- Photodisruption: 6.5 µm ± 20% in air |
| Safety Standards | Compliance with relevant IEC and ANSI standards | - ANSI/AAMI ES60601-1:2005/(R) 2012- ANSI Z80.36-2016- IEC 60601-1-2:2014- IEC 60825-1:2007- IEC 60601-2-22:2012- IEC 62133: 2012- IEC 60601-4-2 |
| Biocompatibility | Meets ISO 10993-1 requirements | Biocompatibility testing on patient-contacting accessories conducted in accordance with ISO 10993-1, evaluating cytotoxicity and sensitization. Demonstrated equivalency to the predicate device. |
| Software | Verification and validation of software as per FDA guidance | Software verification and validation testing conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Demonstrated that the product works as designed. |
| Functional Performance | Meets defined specifications | Non-clinical system testing evaluated system relevant to each specification. Functional and system-level testing showed the system met the defined specifications and demonstrated non-clinical equivalency to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not describe specific clinical test sets with patient samples. The studies are primarily non-clinical: biocompatibility testing, laser safety, electrical safety, EMC, software V&V, and bench testing. These types of tests do not typically involve patient samples and thus, information on data provenance like "country of origin of the data" or "retrospective/prospective" is not applicable in the context of this submission. The device is being cleared based on substantial equivalence to existing devices through comparison of design and non-clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not detail clinical studies involving experts to establish ground truth for a test set. This type of information is typically required for AI/CADe devices or those relying on human interpretation of images/data. The current submission is for a medical laser, and its performance is evaluated based on technical specifications and safety standards, not clinical diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as there is no described clinical test set requiring expert 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. The VISULAS combi is an ophthalmic laser for direct treatment (photocoagulation and photodisruption), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a treatment laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is primarily based on compliance with established technical specifications, international safety standards (e.g., IEC, ANSI, ISO), and performance equivalence to predicate devices, as demonstrated through engineering tests (bench testing). For biocompatibility, the ground truth is established by the results of standardized biological evaluation tests (ISO 10993-1).
8. The sample size for the training set
Not applicable. This device is a hardware-based medical laser, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
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