(63 days)
The OP085 is used with the COMPACT INTUITIV System. The OP085 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.
The Multiple-Use Pack, Model OPO85 is a reusable phacoemulsification pack that is an optional accessory for use with the COMPACT INTUITIV Phacoemulsification System (K133115), which is used to facilitate the emulsification and removal of a cataractous lens. The primary predicate device, the Single-Use Fluidics Pack, Model OPO80, is cleared for use with the COMPACT INTUITIV System and the secondary predicate device, the Sovereign Reusable Pack, Model OPO55, is cleared for use with the Sovereign Phacoemulsification System. Both the predicates share the same technology, intended use, and performance specifications as the subject device. The Multiple-Use Pack, Model OPO85, consists of a housing manifold, irrigation and aspiration tubing, irrigation inlet tubing connector, and a drain pump tubing connection. Like the secondary predicate device, Model OPO55, the OPO85 Pack is designed for reuse up to 19 times, for a total of 20 uses.
The provided text is a 510(k) summary for the COMPACT INTUITIV Multiple-Use Pack, Model OP085. It primarily details the device's substantial equivalence to predicate devices based on non-clinical performance data.
Here's an analysis of the acceptance criteria and study information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of detailed acceptance criteria for each performance parameter with corresponding reported device performance values. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All acceptance criteria were met. | "all tests passed and all acceptance criteria were met" during performance testing of anterior segment ophthalmic surgery modes. |
| Similar safety, effectiveness, and performance profile as the predicate device (OPO80). | Verification and validation testing met all acceptance criteria, demonstrating similar safety, effectiveness, and performance profile. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the test sets used in the parametric measurements, irrigation, aspiration, biocompatibility, or sterilization testing. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the studies described are non-clinical performance and engineering tests (parametric measurements, irrigation/aspiration, biocompatibility, sterilization, reprocessing) rather than studies requiring expert interpretation of clinical data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of expert interpretations in clinical studies, which were not performed. The testing procedures mentioned (parametric measurements, irrigation/aspiration, etc.) would have pass/fail criteria based on engineering specifications rather than 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
No such study was done. The document explicitly states: "No clinical studies were deemed necessary to determine the safety and effectiveness of the Multiple-Use Pack - OPO85." This device is a fluidics pack for a phacoemulsification system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical medical device like a phacoemulsification fluidics pack. The "standalone performance" concept typically refers to the performance of an algorithm or AI system without human intervention. The testing performed was on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As the studies were non-clinical performance tests, "ground truth" was established by engineering specifications, regulatory standards, and pre-defined pass/fail criteria for various physical and functional parameters (e.g., flow rates, pressure, material integrity after sterilization, biocompatibility according to ISO standards). It was not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.