(371 days)
Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.
The present document describes the reprocessing of Phacoemulsification Tips. From the provided information, we could not extract the acceptance criteria and the comprehensive details of the study for the Phacoemulsification tips.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance: Not specified
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified
4. Adjudication method: Not specified
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable based on the provided text. The document describes laboratory and bench testing, not a clinical study involving human readers.
6. Standalone performance: Standalone performance was conducted through bench and laboratory testing. The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips." The listed tests include: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.
7. Type of ground truth used: For the performance data listed in point 6, the ground truth would be established by validated test methods and specifications relevant to each testing category (e.g., specific parameters for biocompatibility, sterility assurance levels for sterilization, defined functional parameters for function tests).
8. Sample size for the training set: Not applicable and not specified. The document describes a reprocessing procedure and validation, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable and not specified.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.