(196 days)
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.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.