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The RAICO Phacoemulsification Tip is used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.

The RAICO Irrigation Sleeve is intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

The RAICO Phacoemulsification Tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Phacoemulsification is a common practice in modern cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye. The ultrasonic handpiece is connected to, and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."

The primary device that is the subject of this 510(k) is a "Phacoemulsification Tip" (or "Phaco Tip") that is connected to the ultrasonic phacoemulsification handpiece. The Phacoemulsification Tip vibrates at an ultrasonic frequency, powered by the handpiece and surgical system, and thus emulsifies the cataract. The fragmented tissue is then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution is used to irrigate the eye and this is passed with the help of an "Irrigation Sleeve", a small molded component that is placed over the Phacoemulsification Tip.

The RAICO Phacoemulsification Tip is packaged with a RAICO Irrigation Sleeve. The RAICO Phacoemulsification Tip and RAICO Irrigation Sleeve are made of medical grade titanium and silicone, respectively.

In addition, test chamber and wrench accessories are included in the package and all of the devices and accessories will be sterilized, labeled and intended for single use only.

The provided text describes a 510(k) submission for a Phacoemulsification Needle (Tip) and Irrigation Sleeve. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific clinical performance acceptance criteria in the way a novel AI-powered diagnostic device might. Therefore, many of the requested categories for AI-specific studies are not applicable.

Here's an analysis based on the information provided, highlighting the differences in evaluation for this type of medical device:

1. A table of acceptance criteria and the reported device performance

The submission focuses on demonstrating substantial equivalence to predicate devices, meaning the RAICO Phacoemulsification Tip and Irrigation Sleeve perform comparably to already-cleared devices. The "acceptance criteria" here are largely defined by equivalence to the predicate and meeting general safety and performance requirements for such devices, rather than specific clinical outcome metrics.

The study proving the device meets the acceptance criteria is described as "Functionality testing to compare the RAICO Phacoemulsification Tips and Irrigation Sleeves to the predicate phacoemulsification tips and irrigation sleeves."

This testing included:

• Priming and tuning of phaco tips with handpiece and phaco machine.
• Cutting properties including resonant frequency, ultrasonic stroke performance, and velocity calculation.
• Irrigation performance.
• Aspiration capability.
• Material tensile strength.

Additionally, sterilization validation, stability (shelf-life), packaging integrity, and biocompatibility evaluation were conducted.

The conclusion states: "As described in this 510(k) Summary, the RAICO Phacoemulsification Tips and Irrigation Sleeves have been demonstrated to be substantially equivalent to the predicate devices for their intended use." This indicates that the results of the aforementioned testing confirmed the RAICO device performs similarly to its predicate, thus satisfying the substantial equivalence requirement.

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 specify exact sample sizes for the functional and performance tests. For this type of device, testing typically involves a sufficient number of units to ensure reproducibility and statistical confidence in the results, often guided by relevant ISO standards for medical device testing. Data provenance is not specified, but it would typically be internal laboratory testing conducted by the manufacturer (RAICO LLC, based in Westmont, IL, USA) or a contracted testing facility. This would be considered prospective internal testing.

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 question is not applicable to this type of device. The ground truth for mechanical and functional medical devices is established through direct physical and performance measurements against engineering specifications and predicate device performance, not observational expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies or for subjective endpoint assessment (e.g., expert interpretation of images with disagreement resolution). The tests performed are objective, measurable physical and functional characteristics.

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. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on:

• Engineering specifications: Meeting defined physical dimensions, material properties, and functional parameters.
• Performance metrics: Objective measurements of irrigation flow rate, aspiration capability, resonant frequency, ultrasonic stroke, and cutting properties.
• Predicate device comparison: Directly comparing these metrics and characteristics to a legally marketed predicate device to demonstrate substantial equivalence.
• Biocompatibility testing: Standardized biological evaluation (ISO-10993).
• Sterilization validation: Ensuring proper sterilization efficacy (AAMI/ISO standards).

8. The sample size for the training set

This is not applicable. There is no AI algorithm being trained for this device.

9. How the ground truth for the training set was established

This is not applicable. There is no AI algorithm being trained for this device.

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