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The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

The Catalys Precision Laser System ("Catalys System") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics 2[patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

This document describes the Catalys Precision Laser System, an ophthalmic surgical laser. The information provided heavily emphasizes bench and cadaver testing for the patient interface component and system functionality, rather than presenting a clinical study involving human patients with clear acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test set with human data, number of experts for ground truth, MRMC study, training set details) cannot be extracted from the provided text. The text focuses on engineering and bench testing to demonstrate design verification and validation for minor design changes to an existing device, not on demonstrating clinical performance of an AI/ML algorithm.

However, I can extract information related to the bench and cadaver testing that was performed.

Here's the closest possible interpretation of your request based on the provided text, focusing on the available information regarding testing:

Device: Catalys Precision Laser System (Ophthalmic Laser)

Purpose of Submission (K170322): This 510(k) submission is for minor design changes to the Patient Interface Component (Liquid Optics Interface - LOI) of an already cleared predicate device (Catalys Precision Laser System; K161455). The study aims to demonstrate that the redesigned LOI, and the system as a whole with the updated LOI, continues to meet intended design specifications and performs as intended.

Acceptance Criteria and Reported Device Performance (based on Bench and Cadaver Testing):

Study Details (for this 510k submission, K170322):

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

   • Bench Testing: Not explicitly quantified in terms of "sample size" for a dataset, but multiple functional tests, sub-assembly tests, and design validation tests were performed. The "test set" here refers to the physical units/components under evaluation.
   • Cadaver Eye Model Testing: Not explicitly quantified in terms of number of cadaver eyes, but performed to demonstrate performance.
   • Data Provenance: The location of the testing is not specified, but the applicant (OptiMedica Corporation) is based in Milpitas, CA, USA. The testing appears to be prospective in the sense that it was conducted specifically for this submission to verify new design changes.

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

   • Not applicable in the context of clinical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, functional requirements, and physical measurements/observations during bench and cadaver testing. The experts involved would be engineers and technical personnel conducting the tests.

3. Adjudication Method for the Test Set:

   • Not applicable. This testing is focused on objective engineering performance and physical verification, not subjective human interpretations requiring adjudication.

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

   • No. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance is being evaluated with and without AI assistance. This submission is for a surgical laser device and its physical components.

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

   • Not applicable in the AI/ML sense. The "algorithm" (software for the laser system) is integrated and operates the device. The testing described focuses on the device's physical performance, not on a standalone AI algorithm's diagnostic accuracy. The text does state that "Bench testing of the predicate device (resident in K161455) with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes made to the LOI." This implies that the core laser control "algorithm" was validated previously.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Design Requirements: The primary ground truth for the device's performance. Tests confirm that the device meets its predefined functional and performance specifications.
   • Physical Measurements/Observations: During bench testing (e.g., maintaining vacuum, sterile barrier integrity).
   • Cadaver Eye Performance: Demonstrating that the system functions as intended with biological tissue regarding physical interactions (eye fit, pressure, seal).

7. The Sample Size for the Training Set:

   • Not applicable. This submission is not for an AI/ML algorithm that requires a "training set" in the conventional machine learning sense. The device's operation is based on pre-programmed designs and physical principles, not on learned patterns from a dataset.

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

   • Not applicable. No training set was used.

In summary, the provided document details the verification and validation of minor design changes to a surgical laser system's physical components through bench and cadaver testing, rather than the clinical evaluation of an AI/ML algorithm for diagnostic purposes.

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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 OP085 is used with the COMPACT INTUITIV System. The OP085 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

The Multiple-Use Pack, Model OPO85 is a reusable phacoemulsification pack that is an optional accessory for use with the COMPACT INTUITIV Phacoemulsification System (K133115), which is used to facilitate the emulsification and removal of a cataractous lens. The primary predicate device, the Single-Use Fluidics Pack, Model OPO80, is cleared for use with the COMPACT INTUITIV System and the secondary predicate device, the Sovereign Reusable Pack, Model OPO55, is cleared for use with the Sovereign Phacoemulsification System. Both the predicates share the same technology, intended use, and performance specifications as the subject device. The Multiple-Use Pack, Model OPO85, consists of a housing manifold, irrigation and aspiration tubing, irrigation inlet tubing connector, and a drain pump tubing connection. Like the secondary predicate device, Model OPO55, the OPO85 Pack is designed for reuse up to 19 times, for a total of 20 uses.

The provided text is a 510(k) summary for the COMPACT INTUITIV Multiple-Use Pack, Model OP085. It primarily details the device's substantial equivalence to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and study information based only on the provided text:

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

The document does not provide a specific table of detailed acceptance criteria for each performance parameter with corresponding reported device performance values. Instead, it makes a general statement:

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 explicitly state the sample sizes for the test sets used in the parametric measurements, irrigation, aspiration, biocompatibility, or sterilization testing. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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)

This information is not applicable as the studies described are non-clinical performance and engineering tests (parametric measurements, irrigation/aspiration, biocompatibility, sterilization, reprocessing) rather than studies requiring expert interpretation of clinical data to establish ground truth.

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

Not applicable, as this refers to adjudication of expert interpretations in clinical studies, which were not performed. The testing procedures mentioned (parametric measurements, irrigation/aspiration, etc.) would have pass/fail criteria based on engineering specifications rather than expert 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

No such study was done. The document explicitly states: "No clinical studies were deemed necessary to determine the safety and effectiveness of the Multiple-Use Pack - OPO85." This device is a fluidics pack for a phacoemulsification system, not an AI-powered diagnostic tool.

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

This question is not applicable to a physical medical device like a phacoemulsification fluidics pack. The "standalone performance" concept typically refers to the performance of an algorithm or AI system without human intervention. The testing performed was on the device itself.

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

As the studies were non-clinical performance tests, "ground truth" was established by engineering specifications, regulatory standards, and pre-defined pass/fail criteria for various physical and functional parameters (e.g., flow rates, pressure, material integrity after sterilization, biocompatibility according to ISO standards). It was not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this device.

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