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The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.

The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a spring is compressed and forces the diaphragm back to the open port position. In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection. The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.

The provided text describes the UniVit™ HE and UniVit™ UHS devices, which are vitreous aspiration and cutting instruments. The document is a 510(k) summary, indicating that the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel technology requiring extensive clinical trials.

The acceptance criteria and device performance are primarily detailed through a series of "Non-Clinical Bench Test Summary Reports" and compliance with harmonized standards. No clinical studies involving human patients were conducted for this submission, nor were there any studies mentioned that involved human readers or AI assistance in interpretation. Therefore, much of the requested information regarding human expert involvement, MRMC studies, or AI specific performance will not be applicable.

Here's the breakdown of the information 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

• UniVit Needle Deformation: All available gauge sizes (20, 23, 25, 27) were tested. The exact number of devices or iterations per gauge is not specified, but it implies a comprehensive test of each type. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Diaphragm Burst: "Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation." This suggests at least one finished device was tested for this specific criterion. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Fluidics: "(2) rabbit eyes" were used. Data provenance is from studies conducted on rabbit eyes, likely internal lab testing by VisionCare Devices, LLC.
• UniVit Metal Flaking: "The testing was done on a finished device." The number of finished devices tested is not specified beyond this. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Tip Temperature: "The vitrector was ran in a worse case condition..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Vibrational Testing: "VCD ran the vitrector up to the highest CPM possible..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.

All tests appear to be retrospective internal bench tests conducted by VisionCare Devices, LLC. There is no indication of external data sources or geographic origin beyond the company's location in California.

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

There were no human experts used to establish a "ground truth" in the context of interpretation or diagnosis as this device is a surgical instrument, not an interpretative AI/image analysis device. The ground truth for the bench tests was based on measurable physical properties (e.g., fracture, pressure escape, temperature, vibration) and visual inspection (e.g., metal flaking, retinal damage in fluidics test) following defined protocols.

4. Adjudication Method for the Test Set

Not applicable. This device is a surgical tool, and the tests conducted were objective bench tests measuring physical performance, not subjective interpretations requiring adjudication.

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

No. An MRMC study was not done. The device is a surgical instrument, not an AI or image-analysis tool that affects human reader performance. No human readers or AI assistance are involved in the specified testing.

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

Yes, in a way, all the bench tests performed are "standalone" in the sense that they evaluate the device's physical performance independent of human-in-the-loop operation, other than setting up and initiating the tests. However, this is not in the context of an "algorithm only" performance as would be applied to AI/software.

7. The Type of Ground Truth Used

The ground truth for the non-clinical bench tests was based on:

• Pre-defined pass/fail criteria for physical properties (e.g., temperature limits, vibration limits, absence of physical damage or leakage).
• Observational criteria, such as the absence of metal flaking or retinal damage in the fluidics test (using rabbit eyes).
• Compliance with recognized harmonized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization).

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 this type of device.

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The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.

The provided text is a 510(k) summary for the Cetus System, a laser system for phacofragmentation of cataractous crystalline lenses. It focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and non-clinical performance data.

However, the document does not contain information related to acceptance criteria, clinical studies, or performance metrics in the way your prompt describes for AI/medical device performance evaluation. Such information would typically include:

• Acceptance Criteria for Device Performance: Specific numerical thresholds for metrics like accuracy, sensitivity, specificity, etc.
• Reported Device Performance: Actual results from tests against these criteria.
• Sample Sizes, Data Provenance, Ground Truth: For clinical or simulated clinical studies demonstrating performance.
• Expert Review/Adjudication: Details on how ground truth was established, especially in diagnostic/imaging devices.
• MRMC or Standalone Studies: Type of clinical efficacy study.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions related to clinical performance, acceptance criteria, or studies proving the device meets them because this information is not present.

The document explicitly states: "Clinical Performance Data: None".

The "performance data" referred to in the document is non-clinical and focuses on compliance with various safety, sterilization, packaging, and risk management standards, rather than the device's clinical efficacy or output performance as measured by typical diagnostic/treatment metrics.

Here's what I can extract from the provided text relevant to the device and its testing, but it does not address your specific request for acceptance criteria and clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance:

• None provided for clinical performance. The document only lists non-clinical compliance standards.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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. The document explicitly states "Clinical Performance Data: None." This device is a surgical tool, not an AI diagnostic tool, so an MRMC study is not relevant in the context of this submission.

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

• No. The document explicitly states "Clinical Performance Data: None."

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

• Not applicable / Not provided. No clinical test set.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an AI algorithm is mentioned as this is a physical medical device.

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

• Not applicable / Not provided. No training set for an AI algorithm is mentioned.

Summary of Non-Clinical Performance Data from the document:

The device's safety and effectiveness were demonstrated through compliance with various non-clinical standards:

• Electrical Safety: AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012
• Laser Safety: IEC 60825-1:2007
• Electromagnetic Compatibility: IEC 60601-1-2:2007
• Sterilization: DIN EN ISO 11135-1:2014
• Packaging Integrity: ASTM F1886/ F1886M-09:2013
• Accelerated Ageing of Sterile Barrier: ASTM F1980-07:2011
• Sterile Packaging: DIN EN 868-5:2009
• Microbial Ranking of Porous Packaging Materials: ASTM F1608-00:2009
• Biological Evaluation of EO Residuals: DIN ISO 10993-7:2009
• Risk Management: ISO 14971: 2007 + Am 2010

The document concludes based on these non-clinical tests that the Cetus system is "as safe and effective as the predicate device."

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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 CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Flex-Tip Laser Probes
· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
· Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
· And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.

UltraVit Probes
· Vitreous aspiration & cutting.
Membrane cutting & aspiration.
· Lens removal.

Endoilluminator Probes
· Endoillumination
Valved Entry Systems
Scleral incision
· Canulae for posterior segment instrument access
· Venting (of valved cannulae)

Infusion Cannulas
Posterior segment infusion (liquid or gas)

The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.

The provided text describes a 510(k) premarket notification for the CONSTELLATION® Vision System, focusing on its substantial equivalence to predicate devices and adherence to various safety and performance standards. However, it does not include the detailed breakdown of acceptance criteria, device performance, or specific study information (like sample sizes, ground truth establishment, or expert qualifications) that you've requested.

The document primarily outlines:

• Indications for Use: The system is for anterior (phacoemulsification, cataract removal, IOL injection) and posterior (vitreoretinal) ophthalmic surgery. Specific probes and systems within CONSTELLATION® (e.g., Flex-Tip Laser Probes, UltraVit Probes, AutoSert® IOL Injector Handpiece) have their own detailed indications.
• Predicate Devices: Several previously cleared Alcon devices (e.g., K101285 CONSTELLATION® Vision System, K121555 CENTURION® Vision System) are listed as predicates.
• Nonclinical Tests and Results: The device's compliance with numerous international and industry standards for sterilization, risk management, electrical safety, electromagnetic compatibility, usability, and biocompatibility is stated.

Therefore, based solely on the provided text, I cannot complete your requested table and study details. The document focuses on regulatory compliance through adherence to standards and substantial equivalence, rather than presenting a performance study with specific acceptance criteria and outcome metrics for the device itself.

The information requested, such as specific performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for test sets, details about ground truth, expert qualifications, or MRMC study results, are typical for AI/ML device submissions, but this document predates broad AI/ML medical device regulation and describes a surgical hardware system with accessories.

Here's a summary of what could be extracted and what is missing, based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The closest are adherence to various safety, sterilization, and biocompatibility standards (e.g., EN ISO 11135-1 for sterilization, UL 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). These are pass/fail criteria for compliance.
• Reported Device Performance: Not provided in terms of quantitative clinical performance (e.g., success rates, complication rates, or diagnostic accuracy). The document states "Safety tests... have demonstrated its compliance with applicable requirements of the following standards" and "Non-clinical testing... has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices."

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

• Not provided. The document refers to non-clinical testing for compliance with standards, not a specific clinical test set with human subject 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. No "ground truth" in the diagnostic sense is established in this document, as it's not a diagnostic AI/ML device study.

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

• Not applicable/Not provided. No human adjudication of a test set 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/ML device. No MRMC study is mentioned.

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

• No. This is not an AI/ML device.

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

• Not applicable/Not provided. "Ground truth" as a diagnostic reference standard is not relevant to the compliance testing described for this surgical system. The "truth" in this context is whether the device meets engineering specifications and safety standards.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

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

• Not applicable/Not provided. This is not an AI/ML device.

In conclusion: The provided document is a 510(k) summary for a surgical system, detailing its intended use and compliance with general medical device standards. It does not contain the specific study design, performance metrics, or "ground truth" information typically associated with the evaluation of AI/ML diagnostic or assistive devices, which is what your questions suggest.

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The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.

The provided document is a 510(k) summary for the Synergetics VersaVit, a vitreous aspiration and cutting instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and device performance metrics.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for clinical trials. Instead, it states that the device "has undergone testing and is in compliance with the applicable requirements of safety standards." and was "found to perform equivalently to the predicate device in a series of bench tests."

The "acceptance criteria" here are largely implied to be "substantially equivalent" or "functionally equivalent" to the predicate device for parameters where direct identical values are not present, or "compliant with applicable safety standards" for overall performance.

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

The document mentions "a series of bench tests" and "internal comparative bench testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests. This is typical for a 510(k) application relying on bench testing for equivalence, rather than clinical studies with human subjects.

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

This information is not provided because the submission primarily relies on bench testing and comparison to an existing predicate device rather than human-read image interpretation or diagnostic performance that would require expert-established ground truth.

4. Adjudication method for the test set:

Not applicable, as the document describes bench testing and not a study requiring adjudication of human interpretations or diagnoses.

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. The document describes a medical device (vitreous aspiration and cutting instrument) and not an AI/CAD system for image interpretation or diagnosis. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

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

Not applicable. This is not an AI algorithm. The device is a surgical instrument.

7. The type of ground truth used:

For bench testing, the "ground truth" would typically refer to established engineering specifications, performance standards, or known performance characteristics of the predicate device against which the subject device's performance is measured. The document states compliance with "applicable requirements of safety standards" and equivalence to the predicate device's performance.

8. The sample size for the training set:

Not applicable, as this is a medical device and 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 this is a medical device and not an AI/machine learning model.

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The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries.

The PROCARE PLUS™ Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis
Removal of lens fragments after cataract surgery;
Remove vitreous traction under the retina producing localized or complete retinal detachment;
Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
Treatment of vitreous loss during cataract surgery;
Clean vitreous strands from the cataract wound;
Provide internal illumination for vitreous surgery;
Provide air pressure for maintaining intraocular pressure for retinal surgery.

The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.

The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The ProCare Plus™ Vitrectomy System is an AC powered device with an internal Li-Ion battery that provides backup power in the event that AC power is interrupted. The system is primarily run from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The ProCare Plus Vitrectomy system provides many of the functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, illumination, and fluid-air exchange.

Here's a breakdown of the acceptance criteria and study information for the ProCare Plus Vitrectomy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the ProCare Plus Vitrectomy System as being substantially equivalent to predicate devices. The acceptance criteria are primarily defined by meeting recognized standards and demonstrating equivalence in operational and technological characteristics. The "reported device performance" columns below generally reflect how the ProCare Plus compares or meets these established characteristics.

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

The document does not explicitly mention a "test set" in the context of clinical trials or AI/algorithm performance. The evaluation described is primarily a non-clinical comparative study against predicate devices and adherence to recognized standards. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a "test set" as typically understood in AI/imaging studies is not applicable to this submission.

The "test set" here refers to the actual physical device prototypes and components that underwent testing against the listed standards and in-house protocols. The provenance of this would be the manufacturing site of VisionCare Devices, Inc.

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

Not applicable, as this is a device substantial equivalence submission, not an AI/algorithm performance study requiring expert ground truth for image interpretation or similar. The "ground truth" for the device's performance is established by objective measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or human-in-the-loop AI evaluations involving subjective assessments or disagreements among experts. The evaluation of this device is based on objective, standardized 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. This submission is for a medical device (vitrectomy system) and does not involve AI or human "readers" in the context of image interpretation or diagnosis. It's a hardware system for surgical procedures.

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

Not applicable. This is not an algorithm or AI product.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and performance benchmarks derived from predicate devices.
• Recognized international and national standards (e.g., IEC, ISO, EN) for medical device safety, electromagnetic compatibility, light hazard protection, sterilization, and packaging.
• Internal validation protocols (e.g., P1-112411 to FP1-113411) with their own predefined pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that utilizes a "training set."

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

Not applicable.

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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 COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

The COLIBRI Disposable Vitrectomy Cutter is a quillotine-style pneumatic handbiece for use during ophthalmic surgery. TThe main components of the device are the handle, diaphragm, inner spring, stainless steel inner and outer cutters, and attached tubing and connectors. The device provides cutting and aspiration functions during removal of vitreous and vitreal membranes in anterior and posterior segment surgeries. It is designed to be used with 20 psi and 30 psi ophthalmic surgical systems.

The provided text describes a 510(k) premarket notification for a medical device (COLIBRI Disposable Vitrectomy Cutter) and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Stating the device's indications for use.
• Listing predicate devices.
• Asserting that the technical characteristics are "similar if not identical" to predicate devices.
• The FDA's letter of substantial equivalence determination.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) because this information is not present in the provided text.

The 510(k) summary provided, in this case, relies on a comparison to predicate devices rather than directly presenting performance study results against predefined acceptance criteria.

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An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

I am sorry, but the provided text is a 510(k) clearance letter for the VMate™ Vitreous Cutting System. This document focuses on the regulatory clearance for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt regarding an AI/algorithm-based device.

Therefore, I cannot extract the information required to populate the table and answer the subsequent questions from this document.

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The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.

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The provided text is a 510(k) clearance letter from the FDA for the "Velocity Advantage" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter primarily confirms that the device is substantially equivalent to a predicate device and can therefore be marketed. It lists the device name, a brief indication for use, and regulatory information.

Therefore, I cannot extract the requested information from this document.

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