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The VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements.

The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.

The VERITAS™ Vision System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) ophthalmic surgery. The device uses ultrasonic energy via finely modulated pulses of energy, interrupted by brief cooling periods, to emulsify and extractous lens. This allows the system to achieve full ultrasound cutting efficiency while introducing less energy to the eye, which reduces risk of thermal damage. The VERITAS™ System performs phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy functions, and is a peristaltic system with a graphic user interface that has updated technology and hardware to meet current electrical and material safety standards.

The VERITAS™ Vision System consists of components that are used to perform cataract surgery, which include the 1) System Console, 2) Wireless Remote Control, 3) Advanced Foot Pedal and 4) Single-Use Fluidics Pack or Single-Use Infusion Pack 5) Swivel Handpiece 6) Hardware 7) Software.

The VERITAS™ Advanced Infusion Pack or VERITAS™ Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS™ Vision System. The VERITAS™ Pack is sterilized using ethylene oxide and is designed for single use only.

This report describes the acceptance criteria and the study that proves the device meets those criteria for the VERITAS™ Vision System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not present a formal table detailing specific, quantifiable acceptance criteria and directly corresponding reported device performance metrics in a side-by-side format. Instead, it states that the device "passed the acceptance criteria" and "all tests passed and all acceptance criteria were met" for various functional aspects.

The performance testing primarily focuses on demonstrating substantial equivalence to predicate devices (WHITESTAR SIGNATURE® PRO Phacoemulsification System and OPO73 Dual Pump Fluidics Pack) rather than meeting predefined numerical acceptance thresholds for novel performance claims.

Based on the text, the acceptance criteria are implicitly tied to the performance and safety profiles of the predicate devices and compliance with relevant standards.

Implicit Acceptance Criteria and Reported Performance (derived from text):

The overall reported performance is that all required acceptance criteria were met, and the device is substantially equivalent to the predicate devices.

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

The document indicates that "bench testing" was performed for design verification and validation. However, it does not specify the sample size (e.g., number of devices, number of tests, volume of data) used in these tests. The provenance of this test data is implied to be internal testing conducted by Johnson & Johnson Surgical Vision, Inc. The document does not specify a country of origin for the data or whether the tests were retrospective or prospective, though design verification and validation testing are typically prospective.

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

The document makes no mention of experts being used to establish ground truth for a test set. The validation relies on meeting technical specifications, safety standards, and functional equivalence to predicate devices, rather than expert interpretation of medical images or diagnostic outputs. Human factors studies were conducted, but these are for usability and risk, not for establishing diagnostic ground truth.

4. Adjudication method for the test set

No adjudication method is described, as the testing performed does not involve subjective assessments requiring adjudication. The device validation relies on objective physical measurements, functional tests, and compliance with standards.

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 MRMC comparative effectiveness study was done. This device is a phacoemulsification system and not an AI-assisted diagnostic or imaging device, so such a study would not be applicable. The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the primary and secondary predicate devices."

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

The device is a medical system for surgical procedures, not an algorithm, so a "standalone" algorithm-only performance assessment as typical for AI/ML devices is not applicable. Its performance is assessed through its mechanical and electrical functionality, and its interaction with a surgeon (human-in-the-loop) is the inherent design.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• Compliance with recognized international standards (e.g., IEC 60601 for electrical safety, ISO 11135 and 11137 for sterilization, ISO 10993 for biocompatibility, ISO 14971 for risk management).
• Demonstrating functional equivalence to legally marketed predicate devices through bench testing.
• Meeting design specifications and requirements for each component and the system as a whole.

This is a form of technical and regulatory compliance ground truth, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set. This device is a hardware/software medical system, not a machine learning or AI model that typically requires a training set.

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

Not applicable, as no training set is mentioned or relevant for this type of device.

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The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE or WHITESTAR SIGNATURE PRO Systems ("WHITESTAR SIGNATURE System(s)"). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

The Dual Pump Pack, Model OPO73 is a single-use phacoemulsification pack that is an optional accessory for use with the WHITESTAR SIGNATURE Phacoemulsification Systems (K151636, K111697 and K060366), which are used to facilitate the emulsification and removal of a cataractous lens. Similar to the predicate device, the Dual Pump Pack, Model OPO73 supports peristaltic and venturi aspiration by means of a tubing interface in combination with an over-molded rear cover consisting of a diaphragm (also called the gasket with fluid channels) and a rear cover designed to generate fluid outflow from a patient's eye through aspiration tubing lines.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Dual Pump Pack, Model OPO73":

Based on the provided document, the device described (Dual Pump Pack, Model OPO73) is a single-use phacoemulsification pack, an accessory for WHITESTAR SIGNATURE Phacoemulsification Systems, intended for irrigation and aspiration during anterior segment cataract surgery. The submission is an Abbreviated 510(k), claiming substantial equivalence to a predicate device, the FUSION Dual Pump Pack, Model OPO71 (K060366).

Acceptance Criteria and Device Performance:

The document states: "During performance testing, all anterior segment ophthalmic surgery modes that require the OPO73 functionality, including irrigation/aspiration, were conducted; all tests passed and all acceptance criteria were met."

However, specific quantitative acceptance criteria and corresponding reported device performance values are not provided in the text. The document broadly states that the device "performs as safely and as effectively as the predicate device" and that "all tests passed and all acceptance criteria were met."

1. Table of Acceptance Criteria and Reported Device Performance:

As specific quantitative criteria and performance metrics are not detailed in the provided text, a table like the one requested cannot be constructed. The document only states that:

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

The document mentions "design verification and validation testing, which include parametric measurements testing and irrigation and aspiration testing." However, it does not specify the sample size used for these test sets (e.g., number of devices tested, number of in-vitro runs).

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from Abbott Medical Optics Inc., located in Santa Ana, California, USA, which submitted the 510(k). The studies conducted are non-clinical (laboratory/bench testing), not patient studies. Therefore, it is considered retrospective in the sense that it's an evaluation of the device itself rather than collecting data from live cases.

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

This information is not applicable and not provided in the document. The studies performed are non-clinical verification and validation tests, not studies requiring expert interpretation of medical images or outcomes to establish ground truth. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving human interpretation or outcomes to resolve discrepancies. The studies described are bench tests with objective pass/fail criteria based on engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were deemed necessary to determine the safety and effectiveness of the Dual Pump Pack - OPO73." The assessment is based on substantial equivalence to a predicate device through non-clinical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable here. The device is a physical medical device (tubing and manifold for a phacoemulsification system), not an AI algorithm. Its performance is inherent in its mechanical and fluidic characteristics, not an "algorithm."

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was based on engineering specifications and performance standards. The document states that "all tests passed and all acceptance criteria were met," implying these criteria were predefined technical parameters the device had to meet to be considered safe and effective and substantially equivalent to the predicate. Compliance with various ISO and AAMI standards (e.g., ISO 14971, ISO 10993 series, ISO 11135, ANSI/AAMI ST72) also defines aspects of this "ground truth."

8. Sample Size for the Training Set:

This information is not applicable and not provided. The "Dual Pump Pack" is a hardware medical device and does not involve AI or machine learning algorithms that would require a training set.

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

This information is not applicable as there is no training set for this type of device.

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The AMO WHITESTAR Signature Pro Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

The subject device is the AMO WHITESTAR SIGNATURE PRO Phacoemulsification System, which is an upgrade to the primary predicate device, the AMO WHITESTAR Signature Phacoemulsification System (K111697). Key device components included in this 510(k) submission are the system console, advanced linear (four-button) foot pedal (ALP), and wireless remote control. The system console and wireless remote control of the subject device are substantially equivalent to the console and wireless remote control of the primary predicate device in K111697. The Advanced Linear foot pedal (ALP) used with the subject device is substantially equivalent to the foot pedal used with the secondary predicate device, the COMPACT INTUITIV System, cleared under K133115.

The subject device is classified under 21 CFR 886.4670 as a "phacofragmentation system," described 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. Like the primary predicate device in K111697, the subject device is used to perform phacoemulsification by applying ultrasonic energy combined with the mechanical action of a vibrating phaco handpiece to the cataractous lens of the eye. The system performs four basic functions: phacofragmentation, irrigation of fluid, diathermy (bipolar), and vitrectomy.

This document is a 510(k) summary for the AMO WHITESTAR SIGNATURE PRO Phacoemulsification System, not a clinical study report. It states that no clinical studies were deemed necessary to demonstrate safety and effectiveness. Therefore, the document does not contain the information required to answer the prompt directly as it pertains to acceptance criteria and performance data from a clinical study for this medical device.

The document focuses on demonstrating substantial equivalence to existing predicate devices (K111697 and K133115) based on non-clinical testing and technological characteristics.

However, I can extract information related to the non-clinical tests that were performed and the standards met, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.

Here's a summary of the non-clinical tests and the "performance" demonstrated by meeting these standards, presented as closely as possible to the requested format, while acknowledging the lack of clinical study data:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

Since no clinical studies were performed, the "acceptance criteria" here refer to compliance with recognized standards and successful completion of non-clinical design verification and validation testing, ensuring the device performs equivalently to its predicates. The "reported device performance" is its successful demonstration of meeting these standards and functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Summary Regarding Clinical Study Details:

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided as no clinical studies were performed. The "test set" for non-clinical studies is not specified in terms of sample size or data provenance beyond general compliance with standards.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
• 4. Adjudication method for the test set: Not applicable. 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: Not applicable. The device is a phacoemulsification system, not an AI or imaging diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm device. Performance was established via engineering and bench testing, demonstrating equivalence to predicates.
• 7. The type of ground truth used: For non-clinical validation, "ground truth" would be defined by engineering specifications, validated test methods, and adherence to recognized standards. The device's performance was compared against these established technical benchmarks and the known performance characteristics of the predicate devices.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

In conclusion, this 510(k) submission relied on non-clinical testing and a demonstration of substantial equivalence to already cleared predicate devices, rather than new clinical studies with defined acceptance criteria and performance metrics for direct patient outcomes.

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