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The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs. The Stairlift is capable of moving adult, adolescent occupants (12 years and up) who are able to remain seated while secured by the safety belt. The Mobile Stairlift is for residential use with proper training. This device can also be used routinely in a hospital environment or as a tool for all types of medical personnel. The target patient population are disabled seated persons i.e. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets the acceptance criteria. The text provided is an FDA 510(k) clearance letter for a "Powered Patient Transport" device named "Genesis (MS-P02-GEN)".

It discusses:

• The FDA's review and determination of substantial equivalence.
• General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
• Additional controls for Class II or III devices.
• FDA guidance documents for changes requiring new premarket notifications.
• Quality System (QS) regulation requirements.
• Compliance with other Act requirements (registration and listing, labeling, medical device reporting, good manufacturing practices, electronic product radiation control provisions, Unique Device Identification System rule).
• Misbranding by reference to premarket notification.
• Contact information for questions.
• Indications for Use for the "Mobile Stairlift" (which is actually the device name, not "Genesis (MS-P02-GEN)", despite being listed under "Device Name" as "Genesis (MS-P02-GEN)").

There is no mention of specific acceptance criteria (like accuracy, sensitivity, specificity, etc.) nor any details about a study conducted to prove the device meets such criteria, the sample size used, expert qualifications, ground truth establishment, or any comparative effectiveness studies with human readers.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Genesis ACTIVE Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

The purpose of this submission is for the marketing clearance for the Genesis ACTIVE Implant System which comprises endosseous root-form dental implants, mating compatible abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Genesis ACTIVE Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Genesis ACTIVE Implant System includes eleven (11) compatible implant abutment designs: Healing Abutments, Straight, Angled Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder, Titanium Temporary Immediate, Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, ANGLEBase®, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device Multi-Unit abutments. The overdenture bar is a dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial or totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology by a Keystone Dental Group company and is used to facilitate the attachment of both fixed and removable prostheses.

Subject device implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium and ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700). They are anodized pink (AnaTite™) to provide a pink color and have the BioSpark™ surface treatment which results in a hydrophilic surface enriched with calcium and phosphorous ions.

All titanium Subject device abutments, accessories and screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R5640). Except for the Titanium Blank abutment design, all titanium Subject device abutments are anodized pink. Post surfaces of select abutments receive a media blasting treatment referred to as AnaTite™ or TiPink.

Subject device PEEK temporary abutments are fabricated from PEEK (PolyEther Ether Ketone) material.

All implants and prosthetic components are one-time use devices. All Subject device components are provided sterile and sterilized by gamma irradiation, except for Titanium Blank abutments and the KDG-Osteon Precision Milled Suprastructure which are provided non-sterile. Devices provided non-sterile or modified are sterilized by steam.

The provided text describes the 510(k) summary for the Keystone Dental Inc. "Genesis ACTIVE Implant System." It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The document explicitly states that no clinical data were included in this submission, which means there was no study proving the device meets acceptance criteria related to human performance or clinical outcomes.

Therefore, many of the requested information points, particularly those pertaining to acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert involvement in ground truth establishment for such studies, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document primarily discusses bench testing and material/design comparisons to establish equivalence, rather than clinical performance acceptance criteria or studies involving human readers or AI.

Here's what can be extracted from the provided text:

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

The document focuses on non-clinical performance testing (bench testing) and material/design specifications for establishing substantial equivalence, rather than specific performance metrics or acceptance criteria typically seen for AI/diagnostic devices in clinical settings. The acceptance is based on demonstrating the new device performs similarly and is as safe and effective as the predicate device through these non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it relies on non-clinical data (bench testing) rather than a clinical test set. The number of samples for each bench test is not specified in this summary document.
• Data Provenance: Not applicable for clinical data. For non-clinical (bench) testing, the tests were conducted according to recognized international standards (e.g., ISO, ASTM, USP).

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 or ground truth established by experts is described, as the submission focuses on non-clinical data.

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

• Not applicable. No test set requiring adjudication in a human reader study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. The document explicitly states: "No clinical data were included in this submission."

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

• Not applicable. This device is a physical dental implant system, not an AI algorithm. Its "performance" is mechanical and biological, not diagnostic or algorithmic.

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

• Not applicable for clinical ground truth. The "ground truth" for this submission are the standards and specifications (e.g., ISO 14801 for mechanical fatigue, ISO 10993 for biocompatibility) against which the device's physical and material properties are tested in a lab setting.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires training data.

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

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

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GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.

GenesisZr® 4Y+ (ST1100) Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.

The provided text is a 510(k) Premarket Notification for a dental device, GenesisZr® 4Y+(ST1100) Zirconia. This document focuses on demonstrating substantial equivalence to a predicate device based on physical, chemical, and performance characteristics, rather than clinical efficacy studies. Therefore, it does not describe an acceptance criteria table, a study proving device performance in a clinical setting, or details related to AI/human-in-the-loop studies.

Instead, the document details nonclinical testing to demonstrate the device meets established specifications and international standards for dental ceramic materials.

Here's an analysis of the provided text based on your request, highlighting what is present and what is absent:

Device: GenesisZr® 4Y+(ST1100) Zirconia

The provided document describes a premarket notification (510(k)) for a dental material, specifically zirconia blanks used for dental restorations. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through nonclinical testing, material characterization, and adherence to recognized standards. It typically does not involve clinical studies or human-in-the-loop performance evaluations as would be expected for a diagnostic AI device.

Therefore, the requested information regarding acceptance criteria for clinical performance, sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance for an AI device is not applicable to this document.

However, I can extract information related to the device's physical and performance characteristics, which serve as its "acceptance criteria" in the context of this 510(k) submission, and how its performance against these criteria was "proven" through nonclinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its physical and chemical properties, as measured through laboratory testing, and its compliance with relevant ISO standards.

Note: The "acceptance criteria" here are largely derived from the requirements of the cited ISO standards (ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 13356:2015 "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). The device's reported performance data are directly compared against these standards to demonstrate compliance.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of specimens tested) for each physical and chemical property test. It states that "United Dental Resources Corporation performed a series of tests" and that "sintered tests coupled with mechanical bench testing confirmed that the device meets specifications."
• Data Provenance: The data is generated from nonclinical bench testing conducted by the manufacturer, United Dental Resources Corporation. The provenance is internal to the company for the purpose of this regulatory submission. The document does not mention the country of origin of the raw data beyond the company's address (University Park, Illinois 60484, USA). The testing is retrospective in the sense that it was completed prior to the 510(k) submission, but it's not retrospective clinical data.

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

• Not Applicable. This submission is for a material device, not an AI diagnostic tool or a device requiring subjective interpretation by human experts to establish ground truth for performance. The "ground truth" for this device lies in its measurable physical and chemical properties and compliance with engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or subjective interpretations, there is no need for an adjudication method. Performance is determined by objective laboratory measurements.

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

• No. This type of study is relevant for diagnostic imaging devices or AI tools where human reader performance is a key metric. For a dental ceramic material, MRMC studies are not applicable. The document states: "Clinical tests have not been performed."

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

• No. This term is only relevant for software/AI devices. The GenesisZr® 4Y+(ST1100) Zirconia is a physical material blank.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective measurements of physical and chemical properties against established international standards (ISO 6872:2015 and ISO 13356:2015). This is a form of engineering/material specification compliance. It is not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device, so there is no "training set." The device is a manufactured product with defined material properties.

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

• Not Applicable. See point 8.

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GenesisZr® UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.

GenesisZr® UHT700 Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown.

The provided text describes the 510(k) Premarket Submission for GenesisZr® UHT700 Zirconia. This submission focuses on demonstrating substantial equivalence to a predicate device (CCRI, Inc., Pavati® Z40.2 (K160867)) primarily through non-clinical testing of physical, chemical, and material properties, and comparison of manufacturing processes and indications for use.

Crucially, no information about a study proving the device meets acceptance criteria for an AI or software algorithm is present in this document. The document pertains to a dental material (zirconia blanks) and its physical and chemical properties, not a software device requiring performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a test set or training set. This document does not describe such a study for this medical device.

The only "performance" discussed relates to the material's physical and chemical properties as measured against established dental material standards (ISO 6872:2015 and ISO 13356:2015).

Here's a breakdown of what is available in the document regarding the device's characteristics, which are the basis for its clearance, but not an AI/ML study:

The available document details the non-clinical testing performed to demonstrate substantial equivalence of the GenesisZr® UHT700 Zirconia blanks to the predicate device, Pavati® Z40.2 (K160867). This is a material science characterization, not a performance study of a diagnostic or therapeutic device with AI/ML components.

Here's the relevant information about the acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria in the context of a dental material:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by international standards for dental ceramic materials (ISO 6872:2015 and ISO 13356:2015) and comparison to the predicate device's properties. The "performance" reported is the measured physical and chemical properties of the GenesisZr® UHT700 Zirconia.

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

This document describes non-clinical bench testing of material properties, not testing on human subjects or clinical data. Therefore, the concept of "test set sample size" in the context of an AI/ML study is not applicable. The sample sizes for the material property tests (e.g., number of specimens for bending strength) are not specified in this summary, but would be standard for material characterization.

• Data Provenance: The data comes from "sintered tests coupled with mechanical bench testing" performed by United Dental Resources Corporation. The location/country of origin of this testing is not specified, nor is whether it was retrospective or prospective in conventional clinical study terms, as it's lab testing.

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

Not applicable. Ground truth for material properties is established by physical and chemical measurements using validated laboratory methods and instruments, not by expert human interpretation.

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

Not applicable. This is not a study involving human readers or interpretation requiring 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:

Not applicable. This device is a dental material, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. No algorithm is involved.

7. The type of ground truth used:

The ground truth used for this device's non-clinical testing is measured physical and chemical properties validated against established international standards (ISO 6872:2015, ISO 13356:2015).

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm requiring a training set.

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

Not applicable. There is no AI/ML algorithm requiring a training set.

In summary, the provided document details a 510(k) submission for a dental material based on substantial equivalence through non-clinical laboratory testing and comparison to an existing predicate device, not through clinical studies of an AI-powered device.

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GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:

• Full contour monolithic crowns and bridges in anterior and posterior regions.
• Anatomically reduced for veneering, crown and bridge frames.
• Bridge to be limited to 3 units with a maximum of 1 pontic.

GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.

The provided document is a 510(k) Premarket Notification for a dental device, GenesisZr™ 4Y Zirconia. This document primarily focuses on establishing substantial equivalence to a predicate device based on material properties, indications for use, and standardized bench testing.

It explicitly states that "Clinical tests have not been performed." Therefore, the document does not contain information related to acceptance criteria for clinical performance, human reader studies (MRMC), or ground truth establishment based on expert consensus, pathology, or outcomes data as would be typically found for AI/imaging devices.

The "acceptance criteria" and "device performance" in this context refer to the results of non-clinical, bench testing against established ISO standards for dental materials.

Here's the information that can be extracted from the provided text, framed within your request:

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

2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of test pieces, batches) used for each non-clinical test. The tests were performed on the GenesisZr™ 4Y Zirconia material itself. The data provenance is from internal testing performed by United Dental Resources Corporation. The document does not specify country of origin for the data or whether it's retrospective or prospective, as these terms are not applicable to the non-clinical material testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on compliance of material properties with established international standards (ISO standards) and not on expert clinical interpretation of data.

4. Adjudication method for the test set
Not applicable. There was no human interpretation or adjudication involved, as it was non-clinical material testing against pre-defined physical and chemical property limits.

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 device is a dental material, not an AI-assisted diagnostic or imaging device. Clinical tests as such were explicitly not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. Performance was evaluated based on the physical and chemical properties of the material itself.

7. The type of ground truth used
The "ground truth" for this submission is compliance with the requirements specified in international standards such as ISO 6872:2008 ("Dentistry - Ceramic materials") and ISO 13356: 2008 ("Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). It also includes a biocompatibility risk management analysis per ISO 10993-1.

8. The sample size for the training set
Not applicable. This is a material, not a machine learning model. There is no concept of a "training set" for the type of testing described.

9. How the ground truth for the training set was established
Not applicable for the reason stated above.

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The Genesis™ Low Temperature Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical device until used for a maximum of 180 days.

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis™ Low Temperature Container System is an assortment of rigid, reusable, stackable containers that are used to enclose other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

The provided document describes the Genesis™ Low Temperature Reusable Rigid Sterilization Container System, detailing its indications for use and performance data to support its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides details of the tests performed but does not explicitly state the exact sample sizes for each test set. For instance:

• Aerosol Challenge: "Containers subjected to an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." implies multiple container samples were used, but the specific number is not given.
• Cycled Aerosol / Limits of Reuse: "After 100 simulated full use cycles or the equivalent followed by an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." again implies multiple samples over 100 cycles, but the number of distinct items tested is not specified.
• Simulated Use: "no recovery of viable challenge organism...from the lumens on the test device after processing within a worst case Genesis Container as part of a worst case cycle simulated use container validation load." This suggests a focus on "worst-case" scenarios, likely involving a limited number of "test devices" and container configurations, but the exact count isn't in the provided text.
• Shelf Life / Package Integrity: "All sample devices remained sterile...following exposure to a full sterilization cycle and weekly rotation events at a 180 day storage duration" implies multiple "sample devices" but the number is not provided.
• Biocompatibility: "Blood hemolysis testing demonstrated that any accessories used..." does not specify the number of accessories or tests performed.

The data provenance is not specified regarding country of origin; however, the context of an FDA 510(k) submission implies testing conducted under relevant regulatory standards. The studies described are prospective in nature, as they involve performing specific tests (e.g., sterilization cycles, aerosol challenges, simulated use, shelf-life studies) to validate performance criteria for the device.

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

The document describes non-clinical performance tests, not clinical studies involving human experts for ground truth establishment. The "ground truth" for these tests is based on objective scientific measurements (e.g., presence/absence of microbial growth, sterility assurance levels, material property changes) as defined by established standards like ANSI AAMI ST 77 2013 and ISO 10993-4 2009. Therefore, there were no human experts establishing ground truth in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance study based on objective measurements against defined standards, not an assessment requiring human interpretation or adjudication for ground truth.

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

No. This document pertains to the performance validation of a sterilization container system, which is a physical medical device, not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used in these studies is objective, measurable criteria defined by recognized scientific standards and validated laboratory methods. This includes:

• Microbiological Negativity: Absence of microbial growth (biological indicators, indicator organisms in aerosol challenge) to establish sterility.
• Sterility Assurance Level (SAL): Quantitative measure (10^-6) of sterilization effectiveness.
• Physical and Mechanical Integrity: Maintaining filter properties (BFE, tear strength, burst strength), container integrity.
• Biocompatibility: Demonstrating no harmful interactions with blood (hemolysis testing).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device undergoing performance validation, not a machine learning model requiring a training set.

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

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

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The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Indications for Patello-Femoral Replacement

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Subject of this Premarket Notification are the Genesis II XLPE resurfacing patellar components manufactured from highly cross linked polyethylene (XLPE) material. The Genesis II XLPE resurfacing patellar components are intended to be used with the following knee systems

• Smith & Nephew Total Knee Systems
• Smith & Nephew Patello-Femoral Knee Systems
• Competitor PFJ Patella-Femoral Knee Implants K051086
• Legion Hinge Knee System K081111
• Genesis II Constrained System K962137

Components of this premarket notification include

• Round and Oval Patellar components manufactured from highly cross-linked polyethylene (7.5 Mrad XLPE) material.

This document is a 510(k) Premarket Notification for the Genesis II XLPE Resurfacing Patellar Components. It is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It describes mechanical testing performed to support a material change, not a study proving a device meets specific clinical acceptance criteria or a comparative effectiveness study.

Therefore, many of the requested sections in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on showing mechanical equivalency rather than clinical performance.

However, I can extract information related to the acceptance criteria for the mechanical testing and the reported performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the mechanical tests (Static Shear and Fatigue Shear Testing). Instead, it states that the tests were conducted "to further support a determination of substantial equivalence" and that "Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate device." This implies that the acceptance criterion was the demonstration of performance comparable to the predicate device, although the specific thresholds for "comparable" are not provided.

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

• Sample Size: Not specified in the document.
• Data Provenance: Not explicitly stated, but these would be bench (mechanical) tests performed in a laboratory setting, likely by Smith & Nephew or a contracted testing facility. This is not clinical data (retrospective or prospective from a country of origin).

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

• Not Applicable. Ground truth in this context would refer to clinical or diagnostic accuracy, which is not evaluated here. The "truth" for mechanical testing is derived from engineering principles and standards, not expert clinical consensus.

4. Adjudication method for the test set

• Not Applicable. This is not a clinical study involving human assessment that would require adjudication. Mechanical tests have objective outputs that are compared against predefined engineering specifications or predicate device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for a medical implant (knee replacement components), not an AI diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

• No. This is not a software algorithm; it is a physical medical device.

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

• Not Applicable / Engineering Standards. For mechanical testing, the "ground truth" would be established by industry-accepted mechanical testing standards (e.g., ISO, ASTM) and comparison to the known performance characteristics of the predicate device, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. (See #8)

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The Dornier Genesis with Windows 7 is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Genesis with Windows 7 is an Image Intensified Fluoroscopic X-ray System. The Genesis with Windows 7 consists of the following components: an x-ray generator and tube housing image detector (flat panel or Image Intensifier), monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.

The provided text describes a Special 510(k) Summary for the Dornier Genesis with Windows 7, an image-intensified fluoroscopic x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies in the way you've outlined for an AI/device performance study.

Here's an analysis based on the information provided, highlighting what is and is not present concerning your request:

The core of this document is a 510(k) submission seeking clearance for a modification to an existing medical device. The primary "study" proving the device meets its acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device. The acceptance criteria for this type of submission are typically adherence to recognized standards and a demonstration that the changes do not introduce new safety or effectiveness issues.

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

No explicit table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) is provided, nor is there reported device performance in those terms. The "acceptance criteria" here are broad regulatory compliance and substantial equivalence to a predicate device.

The "performance data" section lists recognized testing standards that Dornier MedTech America, Inc. states the device complies with:

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 document describes compliance with standards and risk analysis, not a clinical performance study with a specific test set of patient data. The modification is primarily a software platform upgrade (Windows XP to Windows 7), implying that the core imaging hardware's performance characteristics are considered unchanged.

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 provided. As there's no mention of a clinical test set for diagnostic performance, there's no discussion of ground truth establishment by experts.

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

This information is not provided.

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

An MRMC study was not mentioned or indicated. The device is an imaging system, not an AI-assisted diagnostic tool in the typical sense of generating interpretations or assisting human readers with diagnostic tasks. The change is an operating system upgrade.

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

A standalone performance study of an algorithm is not mentioned or indicated. This is not an algorithmic diagnostic device, but rather an imaging system.

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

Ground truth for diagnostic performance is not applicable in the context of this 510(k) summary, as it's not a diagnostic algorithm undergoing validation of its diagnostic accuracy. The ground truth for the engineering tests mentioned would be the specified requirements of the standards (e.g., specific measurement readings, functional tests).

8. The sample size for the training set

This information is not provided. This device is not an AI/machine learning product that requires a training set for model development.

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

This information is not provided. This is not applicable to the device described.

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The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

The provided document is a 510(k) premarket notification for a medical device (Genesis™ Reusable Rigid Sterilization Container System). It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance tests.

Here's an analysis of the acceptance criteria and study information provided, focusing on the available details:

Description of Acceptance Criteria and Device Performance

The device under review is the Genesis™ Reusable Rigid Sterilization Container System. The primary function of this system is to enclose other medical devices for sterilization and maintain their sterility for up to 180 days. The acceptance criteria for this device revolve around demonstrating its efficacy in sterilization and maintaining sterility under various conditions.

The study presented focuses on non-clinical performance testing to validate the sterilization efficacy and dry time of the container system for specific sterilization modalities and contents.

1. Table of Acceptance Criteria and the Reported Device Performance:

Additional Performance Parameters and Conditions (from "Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality" and "Accessories and Device Challenges by Sterilization Modality and Container Style" tables):

The document explicitly states: "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." This indicates that for all the criteria mentioned in the tables, the device successfully demonstrated compliance through the stated non-clinical tests.

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

• The document mentions "Testing" for sterilization efficacy and dry time but does not specify the exact sample sizes (number of containers, number of cycles, number of biological indicators, etc.) for the test sets.
• Data provenance is not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. Given it's a 510(k) submission for a medical device by a US-based company (CareFusion 2200 Inc, Vernon Hills, IL), and referring to an FDA guidance document (ST 77 2013), it is prospective testing conducted in a controlled laboratory setting, likely within the US.

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

• This document describes non-clinical performance testing of a sterilization container, not a diagnostic or AI-driven medical imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists) is not applicable.
• The "ground truth" for sterilization efficacy is established by scientific principles and validated biological indicators (BI) and sterility assurance levels (SAL) as per recognized standards (ST 77 2013). The validation of dry time is based on the "absence of visible moisture." These are objective measurements rather than subjective expert consensus.

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

• As this is non-clinical performance testing, adjudication methods typically used for subjective clinical assessments are not applicable. The results are based on objective laboratory measurements and adherence to specified performance 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, this is not applicable. The document is for a physical medical device (sterilization container), not an AI algorithm or a diagnostic tool involving human readers.

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

• No, this is not applicable. This document pertains to a physical sterilization container.

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

• The ground truth for the performance of the sterilization container is based on objective measurements of sterilization efficacy and dryness as defined by recognized industry standards (ST 77 2013).
  • For sterilization efficacy: achieving a 12 log reduction and a Sterility Assurance Level (SAL) of 10^-6 using biological indicators (overkill method).
  • For dry time: absence of visible moisture.

8. The sample size for the training set:

• Not applicable. This relates to a physical device evaluated through non-clinical performance testing, not an AI model that requires a training set.

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

• Not applicable. As indicated in point 8, there is no training set for this type of device evaluation.

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The Dornier GENESIS II is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Genesis II is an Image Intensified Fluoroscopic X-ray System. It is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Genesis II consists of the following components: an x-ray generator and tube housing, image intensifier detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.

The Genesis II is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted over the table on a fixed arm. An image intensifier is mounted underneath the patient table. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position.

The provided text describes the 510(k) premarket notification for the Dornier MedTech America, Inc. Genesis II device, an Image Intensified Fluoroscopic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific quantitative acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states, "a board certified radiologist evaluated a number of sample images obtained using the Genesis II." A specific numerical sample size is not provided.
• Data Provenance: The origin of the sample images (e.g., country of origin) and whether the data was retrospective or prospective is not specified.

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

• Number of Experts: "a board certified radiologist" — this suggests one expert.
• Qualifications of Experts: The expert was a "board certified radiologist." No further detail (e.g., years of experience) is provided.

4. Adjudication method for the test set

• "a board certified radiologist evaluated... and determined..." This indicates that the evaluation was performed by a single expert. There is no mention of an adjudication method involving multiple experts to establish ground truth or resolve discrepancies, as only one expert is noted.

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, an MRMC comparative effectiveness study was not done. The document describes the evaluation of image quality of the device itself, not the performance of human readers with or without AI assistance. This device is an imaging system, not an AI-based diagnostic tool for interpretation.

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

• This question is not applicable as the Genesis II is an X-ray imaging system, not an algorithm or AI device that performs diagnoses independently. The evaluation described is for the diagnostic quality of the images produced by the hardware, which would then be interpreted by a human.

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

• The ground truth for the image quality assessment was established through expert opinion/evaluation by a single board-certified radiologist, who determined if the images were of "acceptable diagnostic quality." There is no mention of an objective reference standard like pathology or outcomes data.

8. The sample size for the training set

• The document implies that the device (Genesis II) itself was designed and verified against established engineering and safety standards, and its image intensifier technology is based on previously cleared devices. It does not describe a "training set" in the context of an algorithm or AI model. Therefore, this question is not applicable for this type of device submission.

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

• As the concept of a "training set" for an algorithm is not applicable to this device, the establishment of its ground truth is not relevant in this context. The device's "training" in a functional sense would be its design, manufacturing processes, and adherence to established technical standards, as well as the prior clearance of its component technologies.

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