FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ALCON Enhanced UltraVit® Probe is a modified vitrectomy probe that will be added to the existing Alcon UltraVit® probe family. The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes used on the CONSTELLATION® System (Alcon Vision System, K063583). The ALCON Enhanced UltraVit® Probe will utilize existing packaging configurations and have the same shelf life as existing vitrectomy probes. It will be used with the CONSTELLATION® System. The differences between the enhanced and predicate versions are:

Increased maximum cut rate. .
. Software look-up table changes to accommodate RFID recognition of new probe.
Parylene N Coating on "O" ring seals. .

AI/ML Overview

Here's an analysis of the provided text regarding the Alcon Enhanced UltraVit Probe's acceptance criteria and studies:

Based on the provided 510(k) summary (K093305) for the ALCON Enhanced UltraVit Probe, please note that this device is a physical surgical instrument and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions regarding AI device performance metrics like sensitivity, specificity, reader studies, ground truth establishment, and training sets are not applicable.

The approval for this device relies on demonstrating substantial equivalence to a predicate device (ALCON® Vision System (CONSTELLATION®) UltraVit Probes, K063583) and adherence to relevant biocompatibility, sterilization, and manufacturing standards.

Here's a breakdown of the requested information, with clarifications for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a vitrectomy probe, "acceptance criteria" relate to meeting safety and performance standards for its intended function, often compared to the predicate device.

Acceptance Criteria Category	Specific Criteria/Standard Met	Reported Device Performance/Evidence
Biocompatibility	Compliance with AAMI/ANSI/ISO 10993 series (Parts 1, 5, 7, 10, 11, 12) for materials in contact with patient/fluid path.	"Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:" (followed by a list of ISO 10993 series standards). This indicates the device met these standards.
Sterilization	Validation of Ethylene Oxide sterilization to a SAL of 10^-6^ per EN ISO 11135-1:2007.	"This product is Ethylene Oxide sterilized and the process has been validated to a SAL of 10^-6^ per FDA Recognized Consensus Standard - 'EN ISO 11135-1:2007...'"
Functional Performance	Functional requirements of a vitrectomy probe, including increased maximum cut rate compared to predicate.	"Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices." The device description explicitly states: "Increased maximum cut rate."
Manufacturing Quality	Compliance with 21 CFR 820 (Quality System Regulation) and ISO 14971:2003 (Risk Management).	"The ALCON® Enhanced UltraVit® Probe has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003."
Physical Characteristics	Same size, shape, and material as existing Alcon UltraVit® probes. Same packaging and shelf life.	"The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes... It will be used with the CONSTELLATION® System." Also, "utilize existing packaging configurations and have the same shelf life."
Software Changes	Software look-up table changes to accommodate RFID recognition of the new probe are functional.	Implied by general functional testing and substantial equivalence claim. Software changes are limited to RFID recognition.

For the following questions, please understand they are largely not applicable or directly answerable in the context of this 510(k) for a physical, non-AI medical device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the traditional sense for an AI/SaMD. The "test set" here would refer to the samples used in non-clinical testing (e.g., material samples for biocompatibility, sterility test loads, functional performance tests on the device itself). Specific sample sizes for such tests are not detailed in this summary but are part of standard device validation protocols. There's no "patient data" test set or provenance mentioned.

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)

Not Applicable. "Ground truth" in the context of an AI device refers to a definitively correct answer against which the AI's performance is measured. For a physical device, performance is measured against engineering specifications, validated test methods, and regulatory standards. Experts would be involved in designing and executing these validation tests, but not in establishing an "image interpretation ground truth."

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review panels for ambiguous cases when establishing ground truth for diagnostic AI. This is not reported for a physical device's non-clinical testing.

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

Not Applicable. MRMC studies are designed to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical instrument, not a diagnostic AI.

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

Not Applicable. This is a physical device, not an algorithm. The "stand-alone" performance would refer to its functional capabilities (e.g., cutting rate, sterility) as assessed through engineering and bench testing.

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

Not Applicable (or rather, the "ground truth" is defined by established engineering standards and regulatory requirements). The "truth" for this device's performance is determined by:
- Biocompatibility test results: Conformance to ISO 10993 standards.
- Sterilization validation: Achieving a specific sterility assurance level (SAL).
- Functional specifications: Meeting defined maximum cut rates and operational parameters.
- Materials specifications: Using specified and validated materials.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

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

Not Applicable. As there is no AI training set, there is no ground truth for a training set.

In summary: The provided 510(k) pertains to a hardware medical device. Its "acceptance criteria" are met through demonstrating compliance with recognized standards for biocompatibility, sterility, manufacturing quality, and functional equivalence to a predicate device through non-clinical testing. The concepts of AI-specific elements like reader studies, ground truth establishment, and training/test sets as typically discussed for SaMDs do not apply here.

Summary

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.