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The Vista Ophthalmics vitrectomy probe is intended to be used to remove vitreous and dissect tissue in the eye as follows:
· Vitreous aspiration & cutting
· Membrane cutting & aspiration
· Lens removal
· Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.

The Vista vitrectomy probe is a pneumatically actuated device which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during anterior and posterior ophthalmic procedures. The Vista vitrectomy probe is offered in a two port bi-blade configuration.
The Vista vitrectomy probe utilizes a pressured air pulse to drive the cutting action. The pressure pulse originates from the operational system of choice and distends or expands a silicone rubber diaphragm inside the handpiece. The pressure pulse fills the pressure chamber of the vitrector, actuating the axial extension of the inner-cutting tube to produce a guillotine-type cutting motion. A vacuum originating from the operational system of choice draws biological materials (tissue and fluid) into the outer cutting port area of the cannula that is inserted into the patient's eye. The vacuum-drawn material entering the outer needle port is then resected by the inner-cutter as it travels down the inside diameter of the outer needle. Once the inner-cutter resects (guillotines) the material as it crosses the distal end of the outer needle port cutting edge, the material is aspirated through the inside diameter of the inner-cutting tube. The material continues to be aspirated through the handpiece and into a collection chamber of the vitrectomy system selected for use with the Vista vitrectomy accessory.

This document describes the 510(k) summary for the Vista Ophthalmics Vitrectomy Probe, K220030. It focuses on demonstrating substantial equivalence to a predicate device, the Alcon Hypervit Vitrectomy Probe (K170520), and a reference device, the Vision Care ProCare Plus (K120170).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific thresholds. Instead, it relies on demonstrating that the Vista Vitrectomy Probe's performance is similar to or meets the performance of the predicate and reference devices in various tests. The key performance evaluations can be inferred from the "Performance Data" section.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state specific sample sizes for each test in the "Performance Data" section. It broadly states that "All validation processes have demonstrated that the functional requirements and finished device specifications are met." without providing numerical details for the number of units tested.

The data provenance is internal testing performed by Vista Ophthalmics LLC. There is no mention of country of origin for data or whether it's retrospective or prospective, as these are typically not applicable to bench and lab testing of a physical medical device for 510(k) clearance based on equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this type of device and 510(k) submission. "Ground truth" established by experts is typically relevant for AI/ML-based diagnostic devices where clinical interpretation is involved. For a surgical instrument like a vitrectomy probe, "ground truth" is established by adherence to engineering specifications, validated test methods, and compliance with recognized standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used for clinical studies involving multiple human readers to resolve discrepancies in diagnoses or assessments, particularly in AI device performance evaluations. The performance data presented here are for technical specifications and material properties of a physical device.

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 information is not applicable. The Vista Ophthalmics Vitrectomy Probe is a surgical instrument, not an AI-assisted diagnostic or decision-support device. Therefore, MRMC studies and evaluations of human reader improvement with AI assistance are irrelevant to this submission.

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

This information is not applicable. As stated above, this is a surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For the performance evaluations, the "ground truth" is established by:

• Recognized standards: ISO 10993-01 (Biocompatibility), ISO 11137 (Sterilization), ANSI/AAMI ST72 (Bacterial Endotoxin), ISTA 6 (Transportation Testing).
• Engineering specifications and validated test methods: For material cutting/aspiration, resistance to deformation, metal flaking, penetration force, and temperature limits. These would be defined internally by the manufacturer, often based on industry best practices and comparison to predicate devices.
• Predicate device performance: The basis for substantial equivalence is that the new device performs similarly to or better than the legally marketed predicate device.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense of a clinical diagnostic truth for this type of device's 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.

HyperVit™ Vitrectomy Probe (27 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:

• Vitreous aspiration & cutting
• Membrane cutting & aspiration
• Lens removal
• Dissect tissue in the eye

The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.

The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.

This document describes the HyperVit™ Vitrectomy Probe, a device designed for vitreous aspiration and cutting, membrane cutting and aspiration, lens removal, and tissue dissection in the eye during vitreoretinal or cataract surgery.

Here's the breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set for each mechanical test. For the metal particulates test, the experiment describes "The probe was actuated at the maximum 10,000 cycles per minute in a water container" and "After running the test continuously for 20 minutes." This implies a single probe was tested for this specific criterion during the specified duration.

The data provenance is from mechanical testing conducted by Alcon Research, Ltd. This is an internal developmental and validation study, not data collected from patient populations. Therefore, country of origin of data or retrospective/prospective nature is not applicable in the patient-data sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests conducted are mechanical and objective (e.g., measuring flow, temperature, presence of particulates, and comparing cut quality to a defined standard), not relying on expert interpretation of ambiguous data to establish ground truth.

4. Adjudication method for the test set:

Not applicable. The tests are objective mechanical performance evaluations, not diagnostic/interpretive tasks requiring 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:

Not applicable. This device is a surgical instrument (vitrectomy probe), not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used:

The ground truth used for these tests is based on:

• Predicate device performance: The HyperVit™ Probe's performance (cut quality, aspiration flow) was compared to the performance of the legally marketed predicate devices (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951).
• Established engineering specifications and safety limits: For heat generation, a maximum allowed temperature increase of 10°C was derived from literature (Wu et al., 2006). For metal particulates, the absence of particulates on microscopy served as the ground truth for meeting the acceptance criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The ALCON® Enhanced UltraVit® Probe is indicated to be used to remove vitreous and dissect tissues in the eye.

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. .

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.

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.

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The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.

This is a 510(k) premarket notification for a medical device cleared by the FDA. As such, it does not contain a study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed performance metrics, sample sizes, expert involvement, and statistical analyses typically associated with clinical trials or AI performance evaluations).

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo clinical study proving novel performance criteria. Clinical studies as described in your request are not typically required for 510(k) clearances if substantial equivalence can be established through other means, such as performance testing detailed below.

Therefore, many of the requested fields cannot be directly extracted or are not applicable in their usual sense for this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device and states that "The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices." It also states "The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use."

Specific, quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The assessment for this type of device typically involves engineering specifications and functional performance tests (e.g., cutting rate, aspiration flow, material compatibility, sterilization efficacy, etc.) to demonstrate equivalence to the predicate device. These specific test results are usually found in the full 510(k) submission, which is more extensive than this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. Performance testing for medical devices like this typically involves a defined number of units, but this information is not in the summary.
• Data Provenance: Not specified, but likely obtained from internal laboratory testing conducted by Advanced Medical Optics, Inc. in the USA. Given it's a 510(k) for an existing type of device, it's almost certainly retrospective in the sense that it relies on established engineering principles and performance testing benchmarks rather than prospective clinical trials to prove efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable (N/A): This type of medical device submission does not typically involve "ground truth" derived from expert consensus in a clinical diagnostic sense, as it is a surgical tool. Its performance is assessed through engineering and functional testing rather than diagnostic accuracy.

4. Adjudication method for the test set:

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic outcomes. For this device, performance is evaluated against engineering specifications and predicate device equivalence, not expert adjudication of clinical findings.

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: This is a surgical instrument, not a diagnostic imaging device or an AI-powered system that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

• No: This device is a manual surgical instrument and does not involve an algorithm or AI operating in a standalone capacity.

7. The type of ground truth used:

• Engineering Specifications / Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device (K950287 UnuVit and 4422CE) and adherence to recognized industry standards (FDA QSR, ISO). Performance is measured against these established benchmarks.

8. The sample size for the training set:

• Not Applicable (N/A): This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable (N/A): As there is no training set for an AI/ML algorithm, this question is not relevant.

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