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The UVE and the MID Labs Bi-Blade™ Vitrectomy Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Bi-Blade™ Vitrectomy Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

The Vitrectomy Cutter, one of the accessories for the Ultimate Vit Enhancer and the subject of this 510(k), 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 surgery. This 510(k) describes dimensional changes to the cutter. Specifically, a second port opening was added, and this created a second cutting edge. As the cutter moves from its retracted position to its extended position, any material in the port is cut by the first cutting edge in cooperation with the distal side of the needle port, just as in the conventional vitrectomy cutter. Unlike the conventional vitrectomy cutter, aspiration is able to continue through the opening in the side of the cutter while the cutter is in the extended position, drawing more material into the port. As the cutter moves from the extended position to the retracted position, this material is cut by the second cutting edge in cooperation with the proximal side of the needle port. Thus, there are two cuts made during a single operating cycle, as opposed to one cut for the conventional vitrectomy cutter.

The provided text describes the 510(k) premarket notification for the Bi-Blade Vitrectomy Cutter. The device is a medical instrument used to remove vitreous and intraocular tissue. The document focuses on demonstrating substantial equivalence to a predicate device (K102222 – Ultimate Vit Enhancer and Accessories) rather than presenting a comparative effectiveness study with human readers or a standalone algorithm-only performance study.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a dataset of patient images or clinical cases for evaluation of an AI/ML algorithm. Instead, the testing described is focused on the device's physical and functional performance.

• For Heat Generation, Metal Flaking, Fluid Dynamics, and Aspiration Flow Rates, the tests were conducted across all four gauges of the Bi-Blade Vitrectomy Cutter (20G, 23G, 25G, and 27G) and a range of cut rates (e.g., 1500 to 8000 cpm, 1000 to 8000 cpm).
• The data provenance is from laboratory testing of the physical device, not patient data. "Porcine vitreous" was used for fluid dynamics testing, indicating an in vitro or ex vivo experimental setup rather than human clinical data.

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

This information is not applicable to this device submission. The submission pertains to a physical medical device, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the performance tests (e.g., maximum temperature, presence of metal flakes) was established through objective measurement and observation during laboratory testing against pre-defined engineering and safety specifications, and comparison to existing scientific literature (for heat generation).

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human expert adjudication of medical cases, but rather objective laboratory measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical surgical instrument and does not involve AI assistance for human readers in interpreting medical data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance studies was based on:

• Objective physical measurements and observations: e.g., temperature readings, microscopic examination for metal flakes, video analysis of marker displacement for fluid dynamics, and flow rate measurements.
• Scientific literature/established safety thresholds: For example, the 10°C temperature increase limit was derived from a literature review on photochemical damage of the retina.
• Comparison to predicate device characteristics: Fluid dynamics were assessed against the performance of the predicate cutter.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical instrument and does not have a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated above.

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The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.

This 510(k) summary describes a medical device, the Ultimate Vit Enhancer (UVE), which is a vitrectomy device. The submission focuses on substantial equivalence to a predicate device and outlines performance testing rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML-driven devices.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. Instead, it broadly states that "functional requirements and specifications have been met." The performance data described are related to the mechanical and physical attributes of the device.

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 a "test set" in the context of patient data or clinical samples. The testing described appears to be laboratory-based bench testing on the device itself and potentially on simulated vitreous material (for fluid dynamics). No patient data is mentioned, thus no country of origin or retrospective/prospective nature can be determined.

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. The testing described is for a mechanical device's physical performance, not for interpreting medical images or making diagnoses that would require expert consensus for ground truth.

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

Not applicable. No expert adjudication is mentioned or implied for the type of bench testing performed.

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 device is a mechanical vitrectomy instrument, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission 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 standalone hardware console used in conjunction with a standard vitrectomy machine and a specific vitreous cutter. It is not an algorithm, and its performance is not evaluated in terms of "algorithm only" performance.

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

For the performance testing mentioned (heat generation, cutter integrity, fluid dynamics), the "ground truth" would be the direct measurements obtained from the physical testing itself against pre-defined engineering specifications and requirements. This is not medical ground truth established by experts or pathology.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system and does not involve a training set.

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

Not applicable. This device is not an AI/ML system and does not involve a training set or its associated ground truth establishment.

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The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.

Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.

This document is a 510(k) Premarket Notification for the MID Labs Autonomous Vit Enhancer. It establishes substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or clinical trial data as would be found in a more comprehensive technical report or clinical study summary.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's what can be extracted and what cannot:

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

• Cannot be provided: The document is a 510(k) Summary and does not contain specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity, throughput) that would typically be reported for a "study." It primarily focuses on comparing features to predicate devices to establish substantial equivalence.

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

• Cannot be provided: The document does not describe a clinical performance study with a test set. This is a device modification submission, not a new device requiring extensive de novo clinical data.

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)

• Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.

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

• Cannot be provided: No adjudication method is mentioned as no independent performance study is described.

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 not an AI device, and no MRMC study or comparative effectiveness study is mentioned. The device is a "Vitreous Aspiration & Cutting Instrument."

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

• No: This is not an algorithm-only device. The device is a "Autonomous Vit Enhancer," which is a stand-alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. Its function is mechanical, not algorithmic for diagnostic purposes.

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

• Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.

8. The sample size for the training set

• Cannot be provided: No training set is mentioned as this device is not a machine learning or AI-based system.

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

• Cannot be provided: No ground truth for a training set is mentioned.

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The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.

Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.

The provided text is a 510(k) summary for the MID Labs Vit Enhancer, a vitrectomy device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to a different type of device clearance (a traditional medical device, not an AI/ML system).

Here's what can be inferred or stated based on the provided text:

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

• Cannot be directly extracted. The document does not define specific performance acceptance criteria for the Vit Enhancer in terms of quantitative metrics or clinical outcomes. The clearance is based on substantial equivalence to a predicate device.

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

• Not applicable / Not provided. The device is a physical instrument, and the 510(k) summary does not describe a clinical study in the way an AI/ML device would require one for performance validation on a test set. There is no mention of a "test set" in the context of data.

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 / Not provided. Ground truth establishment for a test set is not part of this 510(k) summary for a physical medical device.

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

• Not applicable / Not provided. No test set or adjudication method is mentioned.

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 relates to AI/ML performance improvement for human readers, which is not relevant to this traditional medical device.

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

• Not applicable. This refers to AI/ML algorithm performance, which is not applicable to a physical vitrectomy device.

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

• Not applicable / Not provided. The concept of "ground truth" in the context of an AI/ML algorithm's output is not relevant to this device's 510(k) submission.

8. The sample size for the training set

• Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.

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

• Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.

Summary of Device and Approval Process from the Document:

• Device: Vit Enhancer (Vitreous Aspiration & Cutting Instrument)
• Intended Use: Used in conjunction with standard vitrectomy machine for vitreous cutting, to remove vitreous and other intraocular tissue.
• Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System (K932669)
• Approval Basis: Substantial equivalence to the predicate device. The 510(k) submission compares the Vit Enhancer's design, intended use, and functional components (guillotine cutter, user interface, energy source, pressure control, output valve, frequency control) to those of the SupraVit, demonstrating that it operates similarly and has the same fundamental technological characteristics.
• The FDA's letter states that the device is "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified." This indicates that the clearance is based on demonstrating the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy through extensive trials.

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The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert involvement, or ground truth establishment.

The document is a FDA 510(k) clearance letter for a device called "Digi-Injector." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also includes the "Indications for Use" for the device.

However, a 510(k) clearance typically involves a demonstration of substantial equivalence, which often relies on comparison to a predicate device rather than presenting detailed performance data from a standalone study with specific acceptance criteria as requested in your prompt. The letter itself does not contain the specifics of any performance study that would establish acceptance criteria.

Therefore, I cannot fill out the requested table or answer any of the questions related to the study design, sample size, or ground truth.

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