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The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.

However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:

General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."

This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.

Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:

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

Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."

To illustrate what would be in such a table, based on the mentioned tests:

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The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The 4x reprocessed Monarch Bronchoscope. MBR-000211-B. (hereafter referred to as "Proposed Device") is similar to the 2x reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Predicate Device").

The Original Monarch Bronchoscope. MBR-000211-A. (hereafter referred to as "Co-Predicate Device") cleared under K193534 is identical to the 2x reprocessed Monarch Bronchoscope ("Predicate Device"), cleared under K203614.

Both device designs are controlled by Auris Health, Inc., throughout their total product lifecycle.

The Monarch Bronchoscope is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that is either discarded or returned to Auris for reprocessing after clinical use. The original singleuse Monarch Bronchoscope was cleared for one clinical use under K193534. The reprocessed single-use (rSUD) Monarch Bronchoscope was cleared for two (2) clinical uses under K203614. This premarket notification intends to gain market clearance for a reprocessed single-use (rSUD) Monarch Bronchoscope that can be reprocessed up to three (3) times, for a total of four (4) clinical uses.

Identical to the Predicate Device, the Reprocessed Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the Predicate Device.

The provided text describes the regulatory clearance of a reprocessed medical device, the Monarch Bronchoscope, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for a diagnostic algorithm, nor does it detail a study that proves a device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification letter from the FDA, confirming clearance for the "4x reprocessed Monarch Bronchoscope" (meaning it can be reprocessed up to three times for a total of four clinical uses). The performance testing described focuses on the physical and functional integrity of the reprocessed device, not on diagnostic accuracy of an algorithm or an AI component.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to diagnostic algorithm validation:

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

The document provides a list of performance tests conducted for the reprocessed bronchoscope, with "Pass" as the result, indicating that the device met internal design specifications and applicable standards for safe and effective reprocessing. These are functional and safety-related criteria for the physical device, not diagnostic performance metrics.

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

This information is not provided in the document. The performance tests refer to "worst case device conditioning" but do not specify the number of devices or clinical cases used in these tests. The data provenance 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)

This information is not applicable to the type of device and testing described. The document pertains to the reprocessing of a physical bronchoscope, not a diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This information is not applicable to the type of device and testing described. Adjudication methods are typically relevant for human-in-the-loop or diagnostic studies, which are not detailed here.

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

This information is not applicable to the type of device and testing described. The document does not mention an AI component or any MRMC studies.

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

This information is not applicable to the type of device and testing described. The Monarch Bronchoscope is a physical device; there is no mention of a standalone algorithm.

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

This information is not applicable in the context of diagnostic performance. For the safety and functional tests performed, the "ground truth" would be the established engineering and biological standards and specifications the device aims to meet (e.g., sterility, electrical safety, cleaning effectiveness).

8. The sample size for the training set

This information is not provided and is not applicable as there is no mention of an algorithm or machine learning model being developed or trained.

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

This information is not applicable as there is no mention of algorithmic training or ground truth for such a purpose.

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The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

• Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
  • Similar intended use.
  • Similar indications for use.
  • Similar fundamental scientific technology.
  • No new harms or unacceptable risks.
• Study That Proves the Device Meets Acceptance Criteria:
  • Type of Study: Non-clinical studies were performed, including:
    • Bench testing.
    • Electromagnetic Compatibility (EMC) testing.
    • Software verification and validation testing.
    • Design verification and validation testing.
  • Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
  • Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
  • Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
    • Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
    • Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
    • Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

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ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.

ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.

ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity.

ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.

The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.

The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.

The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.

The provided document is a 510(k) Premarket Notification for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A). It focuses on demonstrating substantial equivalence to predicate and reference devices, primarily through technological characteristics and non-clinical performance data, rather than new clinical performance data for the subject device.

Therefore, the document does not contain the following information typically associated with a study proving a device meets acceptance criteria:

• A table of acceptance criteria and reported device performance based on a new clinical study.
• Sample sizes used for a new clinical test set.
• Number of experts used to establish ground truth or qualifications of those experts.
• Adjudication methods for a new clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance data.
• Type of ground truth used (as no new clinical ground truth development is described).
• Sample size for a training set (as this is not an AI/ML device with a training phase).
• How ground truth for a training set was established.

Instead, the document states:

"Demonstration of the physical, chemical and sphere/toric optical design equivalency of the subject device to the predicate device and multifocal design equivalency to the reference device supports the safety and effectiveness of the subject device. Therefore, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, clinical performance data to demonstrate substantial equivalence are not required."

This indicates that the acceptance criteria for this device's approval were primarily based on its technological similarity and non-clinical performance data being equivalent to already approved devices, rather than a new clinical trial proving performance against defined clinical acceptance criteria.

However, the document does list non-clinical performance data (in-vitro and in-vivo tests) that were performed to assess properties, safety, and effectiveness. While not a "clinical study" in the sense of patient outcomes for acceptance criteria, these tests serve a similar purpose for demonstrating safety and performance.

Here's an attempt to extract relevant information based on the provided text, interpreting "acceptance criteria" as meeting the standards set by the predicate/reference devices and safety tests, since a traditional clinical study with defined performance metrics isn't presented:

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

The approval of the ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) was primarily based on demonstrating substantial equivalence to predicate and reference devices through:

1. Comparison of technological characteristics.
2. Non-clinical performance data (in-vitro and in-vivo tests) to assess properties and safety.

The acceptance criteria are implicitly met by demonstrating that the subject device's properties and safety profile are comparable to or within acceptable ranges of previously cleared devices and established safety standards.

1. Table of Acceptance Criteria (Implied by Predicate/Reference Equivalence and Non-Clinical Tests)

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The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.

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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 reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.

The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.

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

The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.

Regarding data provenance:

• Country of Origin: Not specified in the provided text.
• Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed 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 given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.

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

This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is established by:

• Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
• International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
• Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).

8. The Sample Size for the Training Set:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.

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The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism.

The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.

When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells.

The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.

This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.

In this case, the "device performance" is the reported property/parameter values.

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The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.

The provided document describes the UNFOLDER Vitan™ Inserter, Model DK9000, which is an intraocular lens (IOL) inserter. It is a Class I device used to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, in combination with the SmartLOAD™ Delivery Technology. The document does not describe an AI/ML device per se but a medical device in general. Therefore, some of the requested information, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about AI/ML algorithm training, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing numerical acceptance criteria and reported device performance for specific metrics. Instead, it generally states that the device "complies with applicable standards" and "passed all acceptance criteria" during functional testing.

• Post-delivery dioptric power
• Image quality
• Overall diameter
• Sagitta
• Surface and bulk homogeneity |
  | Overall Safety and Effectiveness | Demonstrated substantial equivalence to predicate devices. Functional requirements and product specifications will be met prior to commercial release. |

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

• Sample Size for Test Set:
  • Reprocessing Study: The study involved processing a sufficient number of UNFOLDER Vitan™ Inserters to verify that they can withstand 500 clinical reprocessing cycles. The exact number of inserters tested is not specified but it states "the inserters" implying multiple units.
  • Functional Delivery Testing: "All tested IOLs" were evaluated. The exact number of IOLs tested is not specified, but the phrase implies a representative sample.
• Data Provenance: The studies were non-clinical tests conducted by Johnson & Johnson Surgical Vision, Inc. There is no information about the country of origin of the data as it's not patient-specific data, but rather device performance data. The studies are described as verification and validation testing, which are typically prospective in nature to assess product performance against design specifications.

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

This information is not applicable as the described tests are non-clinical device performance tests. Ground truth in the context of expert consensus is typically associated with clinical studies or AI/ML evaluations where human experts label or interpret data. For device performance testing, "ground truth" is typically defined by engineering specifications and objective measurements against those specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations when there's a need for consensus among multiple human readers/experts to establish a definitive "ground truth" for ambiguous cases. For device performance testing, results are typically determined by objective measurements and passing/failing predefined specification limits.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, often with and without AI assistance, which is not relevant for a standalone medical device like an IOL inserter that doesn't involve interpretation by human readers in the same way.

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

This information is not applicable. The device described is a physical instrument (IOL inserter), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used

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

• Engineering Specifications and Functional Requirements: For the reprocessing study, the ground truth was the device's ability to maintain its "functional properties," remain "intact," and "successfully deliver IOLs per the Directions for Use," ultimately meeting its predefined design and performance specifications.
• Established ISO Standards (ISO 11979-3: 2012): For functional delivery testing, the "ground truth" was defined by the acceptance criteria mentioned in Section 5 of ISO 11979-3: 2012, specifically for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. These standards provide objective, measurable criteria for IOL delivery performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

This information is not applicable (as explained in point 8).

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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 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 COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80.

The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference.

The provided text does not describe acceptance criteria for an AI/ML device in the traditional sense, nor does it detail a study proving such a device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (a phacofragmentation system and its foot pedal) that does not incorporate AI/ML.

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 predicate device." This clearly indicates that the device being reviewed is not an AI/ML device requiring complex performance studies.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the product described in the input document.

The "Performance Data" section (Page 3) discusses:

• Design verification and validation testing, including electromagnetic compatibility testing: This ensures the physical device (foot pedal) works as intended and is compatible with the system.
• Software validation: This was performed on a proposed software version with minor changes to accommodate the new foot pedal, ensuring the software functions correctly with the new component.
• Acceptance criteria for these engineering and software tests were met. Without further details, these acceptance criteria are likely related to electrical safety, functional performance (e.g., foot pedal response time, correct input recognition), and electromagnetic compatibility limits.

The document concludes that the new closed-toe foot pedal is substantially equivalent to the predicate open-toe foot pedal based on these non-clinical bench tests and software validation.

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