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The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The COMPACT INTUITIV™ System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80.

The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference.

The provided text does not describe acceptance criteria for an AI/ML device in the traditional sense, nor does it detail a study proving such a device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (a phacofragmentation system and its foot pedal) that does not incorporate AI/ML.

The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device." This clearly indicates that the device being reviewed is not an AI/ML device requiring complex performance studies.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the product described in the input document.

The "Performance Data" section (Page 3) discusses:

• Design verification and validation testing, including electromagnetic compatibility testing: This ensures the physical device (foot pedal) works as intended and is compatible with the system.
• Software validation: This was performed on a proposed software version with minor changes to accommodate the new foot pedal, ensuring the software functions correctly with the new component.
• Acceptance criteria for these engineering and software tests were met. Without further details, these acceptance criteria are likely related to electrical safety, functional performance (e.g., foot pedal response time, correct input recognition), and electromagnetic compatibility limits.

The document concludes that the new closed-toe foot pedal is substantially equivalent to the predicate open-toe foot pedal based on these non-clinical bench tests and software validation.

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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:

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.

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