(70 days)
The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:
- . Diabetic retinopathy (panretinal photocoagulation)
- . Macular degeneration
- Peripheral neovascularization .
- ◆ Retinal breaks
- Retinal detachments
- . Retinal tears
- Lattice degeneration
- Pneumatic retinopexy reattachment procedures .
- . Segmental peripheral photocoagulation
- . Segmental photocoagulation
- . Cloudy vitreous cavities
- Pediatric retinal repairs (under general anesthesia) .
- . Delivery of laser energy through small pupils or to eyes with focal lens opacities
The OptiMedica Laser Indirect Ophthalmoscope (LIO) is intended for use in the diagnosis and treatment of ocular pathology. The LIO illuminates and magnifies the fundus image. When connected to the Pascal Retinal Photocoagulator, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.
Here's an analysis of the provided text regarding the OptiMedica Laser Indirect Ophthalmoscope (LIO) acceptance criteria and supporting study:
The provided document is a 510(k) summary for the OptiMedica Laser Indirect Ophthalmoscope (LIO). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily aimed at proving this equivalence, particularly in terms of technical characteristics and optical performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the technical specifications of the predicate devices. The reported device performance is compared against these predicate specifications.
| Characteristic | Acceptance Criteria (Predicate Range/Value) | Reported Device Performance (OptiMedica LIO) |
|---|---|---|
| Intended Use | Delivery of laser energy in eyes with retinal pathology (similar to predicate LIOs) | Similar to predicate LIOs |
| Treatment Wavelength | 532nm (Pascal Photocoagulator, predicate systems) | 532nm (used with Pascal Photocoagulator) |
| Aiming Wavelength | 635nm (Pascal Photocoagulator, predicate systems) | 635nm (used with Pascal Photocoagulator) |
| Eye Filter Optical Density | OD > 5 (all predicate devices) | OD > 5 |
| Aerial Spot Size | 973um (Lumenis systems), 1060um (Zeiss LIO) | 960um |
| Working Distance | 270mm (Lumenis systems), 280mm (Zeiss LIO) | 275mm |
| Fiber Length | 5 meters (Zeiss LIO), 4.6 meters (Lumenis/Coherent systems) | 5 meters |
| Electrical Requirements | Same as predicate devices | Same sort of illumination source as predicate devices |
| Cooling Methods | Same as predicate devices | Same sort of illumination source as predicate devices |
| Weight | Roughly same as predicate devices (Heine Omega 500) | Roughly same (uses Heine OMEGA 500) |
| Dimensions | Roughly same as predicate devices (Heine Omega 500) | Roughly same (uses Heine OMEGA 500) |
| Optical Transmissions | Not explicitly quantified, but "optical similarity" to Zeiss LIO | Measured, intended to show optical similarity to Zeiss LIO |
| Delivered Spot Size & Intensity Profiles | Not explicitly quantified, but "optical similarity" to Zeiss LIO | Measured, intended to show optical similarity to Zeiss LIO |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" for this 510(k) submission appears to be a comparison of the OptiMedica LIO's physical and optical characteristics against those of predicate devices.
- Sample Size: The document does not refer to sample sizes in the traditional sense of patient data. Instead, it refers to a comparative analysis of the physical and optical properties of the OptiMedica LIO against a selection of predicate devices (Zeiss LIO, Lumenis Novus 3000, Lumenis Novus VARIA, Coherent Novus Verdi systems). The "sample" here would be the physical devices themselves.
- Data Provenance: The data is generated through performance testing of the OptiMedica LIO in a laboratory setting, specifically characterizing its optical performance. This is prospective data generation for the comparison. The specifications for the predicate devices would come from their own regulatory submissions or product specifications, which are retrospective for the purpose of this comparison. The country of origin for the data (testing lab) is not specified, but the applicant (OptiMedica Corporation) is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the traditional sense. The "ground truth" for this submission is based on the technical specifications and established performance of the predicate devices, which were themselves cleared by regulatory bodies (e.g., FDA) based on their own submissions. These specifications are taken as the benchmark.
- Qualifications of Experts: No external experts were used to establish "ground truth" for the test set of device characteristics. The "expertise" lies within the engineering and scientific teams that designed and tested the OptiMedica LIO, ensuring its compliance with the established technical parameters. The FDA's review process itself involves expert assessment of the submitted data.
4. Adjudication Method for the Test Set
Not applicable. There's no human adjudication process described for comparing the technical specifications. The comparison is objective, based on measured physical and optical parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
This submission is a 510(k), which focuses on substantial equivalence based on technical and performance characteristics, not on a direct comparison of diagnostic or treatment efficacy in a clinical setting with human readers. The document states: "Performance testing has been conducted with the OptiMedica LIO to establish the optical similarity of the OptiMedica LIO with respect to a predicate device, the Zeiss LIO, as a means to assess the relative clinical performance of the devices." This indicates a technical comparison, not a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a laser indirect ophthalmoscope, a piece of hardware used by a human clinician for diagnosis and treatment. It is not an algorithm or an AI-powered system that would have a "standalone" mode in the context of image analysis or diagnostic predictions.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established technical specifications and validated performance characteristics of the predicate devices. The OptiMedica LIO aimed to demonstrate that its technical and optical performance aligns closely with these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument (hardware), not a machine learning algorithm. Therefore, there is no "training set" in the computational or AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned or implied for an AI/ML algorithm, this question is not relevant to the described device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.