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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 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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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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Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge, Model 1VIPR30 to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.
The Model DK7796 handpiece is used in combination with the Model 1MTEC30 cartridge to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.

The One Series ULTRA Cartridge, Model 1VIPR30, remains unchanged with respect to the predicate device that was cleared on October 2, 2008 under 510(k) K081545. The only modification to the 1VIPR30 device in comparison to the predicate device is with the coating material on the inside of the cartridge. The 1MTEC30 Cartridge is a smaller version of the 1VIPR30 and was assessed under a 510(k) Note-To-File. Both the 1VIPR30 and the 1MTEC30 Cartridges are used to fold and assist in the insertion of AMO Intraocular lenses that allow use of this 1VIPR30 and 1MTEC30 in the approved IOL labeling, ONLY into the capsular bag following cataract extraction: the tip of the cartridge has direct contact with the eye. They are both single-use devices composed of injection-molded polypropylene. The coating of the cleared 1VIPR30 Cartridge (predicate device) is biologically-derived material. The new coating will be made of synthetic materials that meets the same functional specifications of the predicate 1VIPR30 Cartridge.

This document describes a 510(k) premarket notification for two intraocular lens (IOL) cartridges, the One Series ULTRA Cartridge, Model 1VIPR30, and the UNFOLDER Platinum 1 Series Cartridge, Model 1MTEC30. The primary change in these new cartridges compared to the predicate device (Model 1VIPR30 cleared in K081545) is the replacement of a biologically-derived internal coating with a new synthetic coating.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes the objective of the non-clinical tests as evaluating "IOL recovery properties following simulated surgical manipulation (ISO 11979-3:2012) of the TECNIS 1-Piece Soft Acrylic Lens under worst-case conditions." The ultimate acceptance criterion is that the new cartridges with the synthetic coating "perform to the same specifications as the predicate device" and are "as safe and as effective as the legally marketed predicate device."

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

The document states that "Design verification and validation testing was performed on the 1MTEC30 Cartridge" and "Design verification was also performed on the 1VIPR30 Cartridge." However, it does not specify the sample size (i.e., the number of cartridges or IOLs tested) used for these tests.

Regarding data provenance:

• The tests were non-clinical (simulated surgical manipulation).
• The location where the tests were conducted is not explicitly stated, but the manufacturer is Abbott Medical Optics Inc., based in Santa Ana, CA, USA.
• The study appears to be prospective in nature, as new testing was performed on the modified devices.

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

This information is not provided in the document. As this was a non-clinical, performance-based study, the "ground truth" would likely be established by adherence to the ISO 11979-3:2012 standard and objective measurements rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided as the study was non-clinical and did not involve human interpretation or subjective assessment that would require an adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

An MRMC study was not conducted, and this section is not relevant as the device is an IOL cartridge, not an AI-assisted diagnostic tool.

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

This section is not relevant as the device is an IOL cartridge, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established through objective measurements of IOL recovery properties in accordance with the ISO 11979-3:2012 standard under simulated worst-case surgical manipulation. This standard dictates the methods and parameters for evaluating IOLs and their delivery systems.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable/not provided as there is no training set for this device.

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The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

The COMPACT INTUITIV System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The system has the same surgical functionality and software features found in the primary predicate device, the SOVEREIGN Compact Phacoemulsification System (K111446) cleared on December 29, 2011. Like the predicate, the COMPACT INTUITIV is a mid-tier peristaltic system with a user-friendly interface that has updated technology and hardware to meet current electrical and material safety standards. The COMPACT INTUITIV consists of the System Console, the Wireless Remote Control, the Four-Button Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80

The provided text is a 510(k) Summary for a medical device called the "COMPACT INTUITIV System," a phacoemulsification system used for cataract surgery. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested details, such as a table of acceptance criteria for a novel algorithm, sample sizes for test sets, expert-established ground truths, and multi-reader multi-case studies, are not applicable or not provided in this document. The device in question is a physical surgical system, not an AI or imaging diagnostic tool that would typically involve such performance metrics.

However, I can extract information related to the device's validation and the methods used to demonstrate its safety and effectiveness, which serves as its "acceptance criteria" in the context of a 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria for the COMPACT INTUITIV System are fundamentally tied to its substantial equivalence to predicate devices (SOVEREIGN Compact Phacoemulsification System and SOVEREIGN Compact Disposable Tubing Set) regarding safety, effectiveness, and performance. The "performance" here refers to its functional operation in all anterior segment ophthalmic surgery modes.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

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

   • Test Set Sample Size: Not specified. The document states that "Testing of all anterior segment ophthalmic surgery modes, including phacoemulsification, diathermy, irrigation, and vitrectomy, was conducted." This implies an engineering/bench testing approach rather than a patient-based test set with a specific sample size.
   • Data Provenance: The document does not specify a country of origin for any "data" in the sense of clinical or image data. The testing was non-clinical, involving engineering verification and validation. The manufacturer is Abbott Medical Optics Inc., located in Santa Ana, CA, USA.
   • Retrospective or Prospective: Not applicable as no clinical or human-subject data was used. The testing was non-clinical (bench testing) and prospective in nature for validating the new device design.

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

   • Not applicable. As this is a physical surgical device undergoing non-clinical technical and safety testing, "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The "ground truth" for these tests would be the established performance characteristics and safety standards outlined in the regulatory guidances and predicate device specifications.

3. Adjudication method for the test set:

   • Not applicable. Since there's no diagnostic task or human variable interpretation, there's no need for an adjudication method like 2+1 or 3+1. Test results are objective (e.g., meeting a power output specification, passing a bio-compatibility test).

4. 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 study was done. This type of study is relevant for diagnostic systems (e.g., AI in radiology), not for a surgical device like the COMPACT INTUITIV System. The device does not involve "human readers" or "AI assistance" in that context.

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

   • Not applicable. This is a surgical device, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The device itself operates, but always with a human surgeon-in-the-loop.

6. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" was based on:
     • Compliance with recognized industry standards: (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, ISO 14971 for risk management).
     • Performance specifications of the predicate devices: The COMPACT INTUITIV System was tested to perform "as safely and as effectively as" the predicate devices.
     • Internal AMO requirements and specifications: The device was developed and tested against these.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model. This is a hardware device being validated against engineering and safety specifications.

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

   • Not applicable, as there is no training set for an algorithm.

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The Laminar Flow Phacoemulsification Tips are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.

The Irrigation Sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

The Phacoemulsification tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to, and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 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."

The fragmentation needle, also referred to as a phaco tip, vibrates at an ultrasonic frequency and emulsifies the cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), is used to irrigate the eye and this is passed with the help of an Irrigation Sleeve. The Irrigation Sleeve directs the irrigation solution across the shaft of the phacoemulsification tip, allowing it to enter the eye during ocular surgery. This small molded component is placed over the Phacoemulsification tip. The proposed tips and irrigation sleeves are made of fitanium and medical grade silicone respectively.

The subject of this 510(k) premarket notification is the Reusable Phacoemulsification Tips (Phaco Tips) & Irrigation Sleeves (Phaco Sleeves), which will be additions to the family of Disposable Laminar Flow Phacoemulsification Tips & Sleeves. The Phaco tips that are the subject of this 510(k) premarket notification have two different designs, straight and curved tip. The same two designs were the subject of the predicate device and have been cleared by the FDA under K111882 (AMO Laminar Flow Phaco Tips). These tips were cleared by the FDA for single use only and now AMO intends to introduce the reusable version of the same models into the market to offer a broad range of products to our customers. These tips will be compatible with all our currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device. Moreover, these 21G tips will also be compatible with our 21G Irrigation Sleeves (Phaco Sleeve), which is the other subject device of this 510(k) premarket notification. The 21G Irrigation Sleeve will have a slightly different design as compared to the predicate device, which has been cleared under K103023 (AMO Irrigation Sleeve). The reduced gauge size (21G) is designed for use with the 21G Phaco tips. The proposed Light Blue and Orange sleeve will be made of the same medical grade silicone material as the predicate device (Yellow Sleeve), with a difference in the colorant to distinguish between the various AMO sleeve offerings in the market.

This looks like a 510(k) summary for a medical device (Laminar Flow Phacoemulsification Tip and Irrigation Sleeve) where the primary change from predicate devices is the claim of reusability, a different gauge size for the irrigation sleeve, and a higher flow rate for the irrigation sleeve.

However, the provided text does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, or accuracy) derived from a study comparing the device's output to a ground truth. Instead, it focuses on demonstrating that the device (the reusable Phaco Tips and Irrigation Sleeves) is substantially equivalent to legally marketed predicate devices, with additional testing performed to support the new features (reusability, different gauge size, higher flow rate).

The document mentions "Functional validation testing has been performed to demonstrate higher flow rate for the proposed irrigation Sleeve," and "Additional testing including Cleaning and Autoclave validation has been performed to demonstrate reusability for both the proposed subject devices." It also lists various standards used in testing.

Given the information provided, I cannot populate the table or answer all the questions as they relate to typical clinical performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance). The 510(k) summary focuses on demonstrating engineering equivalence and safety for the reusable aspect and functional performance (like flow rate), rather than diagnostic accuracy or effectiveness in terms of human reader improvement.

Here's what I can extract and state based on the provided text, and where I must note missing information:

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

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

• Sample Size: Not specified for any of the individual tests. The document refers to "various testing" and "studies" but does not give numerical sample sizes.
• Data Provenance: Not specified. Assumed to be internal testing by Abbott Medical Optics Inc., located in Santa Ana, CA, USA.
• Retrospective/Prospective: Not specified, but functional and validation testing would typically be prospective (conducted specifically for this submission).

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 as this is not a diagnostic device involving expert adjudication of ground truth for performance metrics like sensitivity/specificity. The ground truth for functional tests would be based on engineering specifications and standard test methods.

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

• Not applicable for the types of engineering and safety tests 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 MRMC study was done. This is not an AI/diagnostic device that would typically involve human readers.

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

• Not applicable. This is not an algorithm-only device. The described tests are for the physical device's functional integrity, safety, and reusability.

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

• The "ground truth" for the tests mentioned (e.g., flow rate, sterilization, biocompatibility, reusability) would be established by:
  • Engineering specifications and measurements: For flow rate, dimensional analysis.
  • Validated test methods and standards: For sterilization (ISO, AAMI standards), cleaning validation, biocompatibility (ISO 10993 series, though not explicitly listed for biocompatibility, it's the standard practice).
  • Animal study observations: For non-clinical animal studies to confirm safety and effectiveness in a biological system.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable. This is not a machine learning/AI device.

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The iFS Laser System is an ophthalmic surgical laser indicated for use:

• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
• In lamellar keratoplasty and corneal harvesting
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
• In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

The iFS Laser System intended use is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser. The iFS Laser System uses focused femtosecond laser pulses to create incisions and separates tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

Acceptance Criteria and Device Performance for iFS Laser System

The provided text describes the 510(k) summary for the iFS Laser System, focusing on its safety and effectiveness, particularly for additional indications like arcuate incisions. While explicit acceptance criteria values for clinical outcomes are not presented in a direct table format, the document outlines various tests and their successful completion, implying meeting predefined safety and performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly met by the reported results. The document states that "All results met the 95% confidence acceptance criteria" for pattern fidelity tests. For clinical trials, safety variables were met, and no statistically significant worsening of symptoms was observed.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Human Cadaver Eye Testing: The exact sample size is not specified, but it involved multiple human cadaver eyes used to create intrastromal and penetrating arcuate incisions.
  • Animal Testing (Rabbits): A "series of studies" were conducted, including a "GLP rabbit study." The exact number of rabbits is not specified beyond "rabbits."
  • Clinical Trial: A total of 21 subjects (presumably 21 eyes) were enrolled.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were conducted under U.S. or international standards recognized by the FDA.
  • Retrospective or Prospective: The "Clinical Trial" section describes a study with "baseline and post-operative visits," indicating a prospective study design. The human cadaver and animal studies would also be prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

• The document primarily describes engineering and performance characteristics, as well as clinical safety outcomes. It does not mention the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging devices (e.g., radiologists interpreting images).
• For the clinical trial, the "ground truth" was established by objective clinical measurements and assessments (e.g., BSCVA, astigmatism, endothelial cell counts, adverse event reporting, symptom questionnaires) and the "Adjudication of outcomes" would be based on the pre-defined study endpoints and statistical analysis.

4. Adjudication Method for the Test Set

• For the clinical trial, the adjudication method is not explicitly detailed in the provided text in terms of reader consensus (e.g., 2+1, 3+1).
• However, standard clinical trial methodology would involve:
  • Objective measurements: Data for outcomes like BSCVA, astigmatism, and endothelial cell counts are objective and would not require reader adjudication in the same sense as image interpretation.
  • Adverse event reporting: Likely adjudicated by the investigative site and/or sponsor according to predefined criteria.
  • Symptom questionnaires: Patient-reported outcomes.
• The phrase "AMO directed study" and "one investigative site" suggests internal oversight and data collection, rather than a multi-center adjudication panel for subjective measures.

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

• No MRMC study was conducted or reported.
• This device is a surgical laser, not an AI-assisted diagnostic tool for image interpretation, so an MRMC study comparing human readers with and without AI assistance is not applicable to the context of this device. The study focuses on the device's ability to perform surgical actions and the resulting clinical outcomes.

6. Standalone (Algorithm Only) Performance

• This concept is not directly applicable in the same way as for an AI diagnostic algorithm. The iFS Laser System is a surgical instrument. Its "performance" is inherent in its ability to execute precise laser cuts.
• The "Pattern Fidelity Testing" could be considered a form of standalone performance evaluation for the device's mechanical and optical precision, demonstrating that the laser itself performs according to its design specifications (e.g., depth, position, angle, diameter).

7. Type of Ground Truth Used

• Engineering/Physical Ground Truth: For "Pattern Fidelity Testing," the ground truth was established by precise measurements of the actual laser cuts against predefined specifications.
• Clinical/Physiological Ground Truth: For the "Human Cadaver Eye Testing" and "Animal Testing," the ground truth was the observable ability of the laser to create the desired incisions in biological tissue and the safety profile (e.g., no perforation, tissue response).
• Clinical Outcome Ground Truth: For the "Clinical Trial Results," the ground truth was based on:
  • Objective clinical measurements: BSCVA, manifest refractive astigmatism, endothelial cell counts.
  • Patient-reported outcomes: Ophthalmic symptoms and vision quality.
  • Adverse events: Clinically observed and reported events.

8. Sample Size for the Training Set

• The text does not provide information on a "training set" in the context of machine learning or AI.
• This 510(k) summary describes a traditional medical device (a surgical laser) and its validation through engineering tests, ex-vivo studies (cadaver/animal), and a clinical trial. It does not appear to involve an AI algorithm that would require a separate training set.

9. How Ground Truth for the Training Set Was Established

• Since there is no mention of an AI algorithm or a training set, the question of how its ground truth was established is not applicable based on the provided document. The device's development and validation follow conventional medical device pathways rather than AI model development pathways.

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The Sovereign Compact Phacoemulsification System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."

The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.

This document describes the regulatory submission for the "Sovereign Compact Phacoemulsification System," which is an upgrade to an existing medical device. As such, the submission focuses on proving substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this regulatory submission for the "Sovereign Compact Phacoemulsification System." This is typical for submissions focused on substantial equivalence to existing, already cleared devices, especially when the changes are primarily software or minor hardware enhancements.

Instead of defining new "acceptance criteria," the submission argues that the device meets the safety and effectiveness profile of its predicate devices through non-clinical testing. The "reported device performance" is implicitly that it performs "equivalently" to the predicate devices in the described modes of surgery.

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

The document does not specify a "test set" in the context of clinical trials or AI/algorithm validation for performance metrics. The evaluation relies on non-clinical testing. Therefore, information regarding sample size and data provenance in this context is not applicable. The "test" here refers to engineering and functional verification and validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the submission did not involve clinical studies requiring expert ground truth establishment for a test set of data. The "ground truth" for the device's functionality and safety is based on engineering specifications, regulatory standards, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication for performance measurement.

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

No MRMC study was done. This device is a surgical system, not an AI or imaging diagnostic tool where MRMC studies are typically performed. The comparison is against predicate devices in terms of function and safety, not an evaluation of human reader improvement with AI assistance.

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

Not applicable. This is a medical device, a phacoemulsification system, which by its nature is used with a human surgeon (human-in-the-loop). There is no "algorithm only" performance study in the context of diagnostic or AI systems for this type of device.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering specifications and regulatory standards: The device was tested to ensure it met its defined functional and safety requirements, which are derived from engineering principles and relevant standards.
• Performance of predicate devices: The primary ground truth for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices (Mojave Cataract Extraction System (K003638), AMO Ophthalmic Surgical System (K060366), and Sovereign Phaco Handpiece (K981116)). The new device is asserted to perform "equivalently" in the same surgical modes.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical system, not an AI or machine learning algorithm that requires a "training set" of data in the conventional sense. The "development" or "training" involves engineering design, prototyping, and testing.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The "ground truth" for the device's development and validation came from established engineering principles, design specifications, and the performance characteristics of previously cleared predicate devices.

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The Laminar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.

Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 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."

The fragmentation needle - also referred to as a phaco tip - referenced in the aforementioned definition is the focus of this 510(k) premarket notification. Phaco tips vibrate at an ultrasonic frequency and emulsify a cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), used to irrigate the eye also passes through the hollow opening of the phaco tip.

The subject of this 510(k) premarket notification is for the Phacoemulsification Tips (Phaco Tips) that are additions to the family of Laminar Flow Phacoemulsification Tips, of which there are two proposed designs: a straight tip and a curved tip. Both Phaco Tip models will be marketed as single-use devices, will be compatible with all currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device; the AMO Profinesse III Needle cleared under the AMO Profinesse III Handpiece 510(k), K951462.

The provided text is a 510(k) summary for a medical device called "Laminar Flow Phaco Tips." This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way one might for a novel AI algorithm or a diagnostic test.

Therefore, many of the requested points regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance are not applicable in this context. The 510(k) summary is designed to show that the new device is as safe and effective as a previously cleared device, not to establish novel performance metrics against a reference standard.

Here's a breakdown based on the provided text:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) with numeric thresholds in the provided text. The overall "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states that performance testing was conducted to demonstrate equivalence. It generally claims the device performs equivalently to the predicate device in terms of safety and effectiveness.

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

• The document mentions "Non-clinical animal studies" but does not specify the sample size (number of animals or eyes) used in these studies.
• The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not a study assessing diagnostic accuracy of an algorithm against expert consensus. The "ground truth" for this type of submission is typically derived from established engineering standards, material properties, and biological responses in animal models, showing equivalence to a known safe and effective (predicate) device.

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

• Not applicable. No expert adjudication method is described as this is not a diagnostic device or AI algorithm evaluation.

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 is a physical medical device (phaco tip), not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" in this context is based on the performance and safety profile of the legally marketed predicate device (AMO Profinesse III Needle, K951462). The goal is to show the new device meets the same performance and safety characteristics.
• Evidence supporting this includes "functional validation testing, sterilization, packaging, and biocompatibility assessments," and "Non-clinical animal studies."

8. The sample size for the training set

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

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