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The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), GENESIS (1-74 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).

Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device. This document focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new device's performance.

Therefore, the sections below requiring information about acceptance criteria and a study proving the device meets them cannot be fully populated as they would for a de novo or PMA submission. The document primarily discusses non-clinical tests to verify design specifications and compliance with standards.

Here's the information that can be extracted or inferred from the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of explicit acceptance criteria with corresponding device performance metrics for efficacy (e.g., specific hair reduction percentages) as would be found in a clinical study report for a new device.

Instead, the document focuses on demonstrating that the device meets safety and performance standards and is technologically equivalent to its predicate. The "performance" discussed primarily relates to meeting design specifications and regulatory standards.

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

The document primarily refers to non-clinical tests for compliance with standards and design specifications. It does not describe a clinical test set with human subjects.

• Test Set Sample Size: Not applicable as a clinical test set is not described. The tests are for device components and system performance.
• Data Provenance: The tests are non-clinical, related to device manufacturing and engineering compliance. No country of origin for clinical data is applicable. The tests are prospective in the sense that they are conducted on the new device to demonstrate compliance.

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

This information is not applicable as the document describes non-clinical engineering and compliance testing, not a clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a clinical study with human observers or interpreters, which is not described 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

Not applicable. This device is a laser hair removal system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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

Not applicable. This device is a physical laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the requirements outlined in the cited international and national standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. These standards provide benchmarks and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. As this document details hardware medical devices, there is no "training set" in the context of machine learning or AI.

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

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

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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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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.
   The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. 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.
   Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

9. Rheumatoid arthritis.

10. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

11. Failed osteotomies, unicompartmental replacement, or total knee replacement.

12. 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.
    The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
· Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

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 tubercule elevation, lateral release) where pain, deformity or dysfunction persists.
   The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. 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.

9. 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 collateral ligament) are incompetent.

10. 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 ligament) are absent or incompetent.
    The Legion Hinge Knee System is for Cemented Use Only.

11. Rheumatoid arthritis.

12. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

13. Failed osteotomies, unicompartmental replacement, or total knee replacement.

14. 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.

15. 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 collateral ligament) are incompetent.

16. 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 ligament) are absent or incompetent.
    The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
2. Previous tibial condyle or plateu fractures with loss of anatomy or function.
3. Varus or Valgus deformities.
4. Revision of previous arthroplasty procedures.
   The devices are indicated for cemented use only.
   The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
  The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Total Knee components are indicated for:

1. Rheumatoid arthritis
2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis
3. Failed osteotomies, unicompartmental replacement, or total knee replacement
4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
   The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

The provided text describes a 510(k) premarket notification for various Smith & Nephew knee systems. The purpose of this submission is not to introduce a new device or significantly change an existing one that would require a new performance study to demonstrate clinical effectiveness or safety based on patient outcomes. Instead, the core of this submission is to add MR safety information to the labeling of existing, already cleared devices.

Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-driven devices (which you are asking about) are not applicable to this 510(k) submission.

The "performance data" section in the document, despite its heading, refers specifically to Magnetic Resonance Imaging (MRI) compatibility testing, not clinical performance of the knee implants themselves. This testing aims to demonstrate that the presence of the knee implants does not pose an undue risk or create excessive artifacts during MRI scans.

Here's why the questions you asked cannot be fully answered or are not relevant to this specific regulatory submission:

• No new device performance for clinical outcomes: This submission isn't about proving a device (like an AI algorithm) is effective at diagnosing or treating a condition. It's about ensuring an existing physical implant is safe in an MRI environment.
• No diagnostic or AI algorithm: The "device" in question here is a knee implant, not a software algorithm that generates clinical insights or diagnoses. Therefore, terms like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth," or "training set" are not applicable.

However, I can extract the relevant information regarding the MR safety testing which serves as the "study" for this particular 510(k) submission:

Acceptance Criteria and Study for MR Safety Labeling (as described in the document):

Since this 510(k) is specifically for adding MR safety information to the labeling of already cleared devices, the "acceptance criteria" and "study" revolve around demonstrating the device's compatibility with MRI environments, not its clinical performance as a knee implant.

1. Table of Acceptance Criteria and Reported Device Performance (for MR Safety)

Summary of Device Performance: The document states that "MR Safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling." This implies that the devices met the requirements of the referenced ASTM and IEC standards for MR compatibility, allowing defined MR conditions (e.g., specific field strengths, gradients, RF levels) for imaging patients with these implants.

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

• Sample Size: The document does not specify the sample size for the MR safety testing. These tests are typically conducted on representative samples of the implant devices themselves, not on human patients.
• Data Provenance: The testing references industry standards (ASTM, IEC, ISO/TS), indicating that the tests were performed in a controlled laboratory environment in accordance with these established protocols. The country of origin of the data is not specified but is presumed to be where Smith & Nephew conducted their R&D and testing. Since it's device testing, not patient data, the retrospective/prospective distinction is not applicable.

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

• Not Applicable: For MR safety testing of physical implants, "ground truth" as established by human experts (like radiologists interpreting images) is not the primary method. The "ground truth" for MR safety is determined by the physical properties of the materials and the design of the device, measured against established engineering and safety standards. The experts involved would be engineers and physicists specializing in MRI safety and material science.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1 for clinical interpretations) are not relevant here. The results of MR safety testing are quantitative measurements (e.g., temperature rise, displacement force, torque, artifact size) subject to direct measurement and comparison against defined thresholds in the standards.

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

• No: This is not applicable. MRMC studies are used to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance. This submission is about the physical safety of an implant in an MRI scanner.

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

• No: This is not applicable as there is no algorithm being tested in this submission.

7. The Type of Ground Truth Used:

• Technical Standards and Physical Measurements: The "ground truth" for MR safety is established by international and national technical standards (ASTM, IEC, ISO/TS) that define acceptable limits for magnetic force, torque, heating, and image artifact. The studies involve physical measurements of these parameters using specialized testing equipment.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" in the context of MR safety testing of physical implants, as this is not an AI/machine learning submission.

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

• Not Applicable: As there is no training set, this question is not relevant.

In summary, this 510(k) submission is a prime example of a regulatory clearance based on engineering and performance testing against recognized standards for physical device properties (MR compatibility), rather than clinical efficacy studies or AI performance metrics.

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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.

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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.

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The O-GENESIS Graft Delivery System is intended to be used for the delivery of allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

The O-GENESIS Graft Delivery System is designed to deliver allograft, autograft or synthetic bone graft material to an orthopedic surgical site. The system consists of a loading syringe, a loading plunger, a loading funnel, a delivery cannula and a delivery gun with an actuating trigger handle. The system is provided sterile and is for single-use only.

In this 510(k) submission, the O-GENESIS Graft Delivery System is a Class II medical device (piston syringe) intended for delivering bone graft material to an orthopedic surgical site. The submission aims to demonstrate substantial equivalence to a predicate device, the GraftGun Universal Graft Delivery System (K170675).

The device in question is a bone graft delivery system, not an AI/ML powered device, so many of the requested elements for AI/ML performance studies (e.g., ground truth, MRMC study, training data, number of experts for ground truth establishment, adjudication methods, standalone performance, effect size of human reader improvement with AI) are not applicable.

However, I can provide information regarding the acceptance criteria for the functional performance of the device and how the study proved these criteria were met, based on the provided text.

Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the functional performance, material characteristics, and biocompatibility of the O-GENESIS Graft Delivery System compared to the predicate device. The acceptance criteria are implicitly derived from the successful completion of various tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Details of the Study

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

   • The document states "Testing was performed using test units representative of the finished devices."
   • Specific sample sizes for each test are not explicitly mentioned in this summary. For example, it doesn't specify how many devices were subjected to simulated use, or how many individual tests were performed for each functional verification parameter.
   • Data Provenance: The studies were conducted by Orthofix, the device manufacturer, as part of their 510(k) submission. The data is prospective as it involves new testing of the manufactured device. The country of origin of the data is implicitly the United States, given the FDA submission.

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

   • Not applicable in the context of this device. This is a mechanical bone graft delivery system, not an AI/ML diagnostic or image analysis device that requires expert interpretation for ground truth. The "ground truth" here is the physical performance of the device (e.g., did it deliver the graft material, did the components withstand force, is it biocompatible). These are established through engineering and biological testing protocols, not expert consensus on medical images or diagnoses.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations (like radiology reads) to establish consensus ground truth. For mechanical and biological testing, results are objective (e.g., passed/failed a force test, biocompatible/not biocompatible based on standardized assays).

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. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical tool, not an AI-powered diagnostic system.

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

   • Not applicable. This device integrates human operation (a surgeon uses the gun to deliver the graft), and there is no "algorithm only" component that would have standalone performance.

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

   • The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
     • For Simulated Use and Functional Verification: The ground truth is the successful operation of the device according to its design specifications and the ability to perform its intended function (delivering graft material) without failure. This is determined by direct observation and quantitative measurements (e.g., force required, successful actuation cycles) against pre-defined engineering acceptance criteria.
     • For Biocompatibility: The ground truth is established by laboratory test results (e.g., toxicity assays) conforming to the requirements of the ISO 10993-1:2009 standard.

8. The sample size for the training set:

   • Not applicable. This device is hardware; it does not involve an AI/ML model that requires a "training set" of data.

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

   • Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites using computer-controlled permanent magnets to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

Here's a summary of the acceptance criteria and study information for the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• ATTRAC: 7/182 (3.8%)
• ATTRAC II: 1/80 (1.3%)
• HEART Study: 7/129 (5.4%)
• VERSATILE: 5/120 (4.2%)
• Total: 20/511 (3.9%) |
  | In vivo testing (Efficacy - ablation success): | Acute Success RMN:
• ATTRAC: 175/182 (96.2%)
• ATTRAC II: 71/75 (94.7%)
• HEART Study: 108/121 (89.3%)
• VERSATILE: 119/120 (99.2%)
• Total: 473/498 (95.0%)
  90 day success RMN:
• ATTRAC: 145/147 (98.6%)
• ATTRAC II: 51/54 (94.4%)
• HEART Study: 82/87 (94.3%)
• VERSATILE: Not reported
• Total: 278/288 (96.5%) |
  | User assessment of device remote controls and safety features: | Same user assessment testing (device remote controls and safety features) as the predicate device was performed, and all safety features passed. |
  | Sterility of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive includes single-use disposable (QuikCAS) which underwent sterilization testing, resulting in a PASS. |
  | Shelf life of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive's single-use disposable (QuikCAS) underwent shelf-life/packaging and sterilization testing. All testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |

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

The "test set" for clinical performance appears to be a collection of existing clinical studies that used the predicate device (Niobe MNS) and compatible components.

• Sample Size: A total of 511 patients were enrolled across 4 studies.
• Data Provenance: Clinical data from retrospective analyses of previously submitted studies to the FDA. These studies were sponsored by Stereotaxis. The specific countries of origin are not explicitly stated within the provided text, but these were part of FDA submissions (P050029, K071029, K140804) suggesting they are likely from clinical trials conducted in regions that align with FDA regulatory standards (e.g., US or international sites that adhere to similar clinical trial practices).

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

The document does not specify the number of experts used to establish the ground truth for the clinical outcomes (adverse events, acute success, 90-day success) in these studies, nor their specific qualifications. It mentions that "Clinical data to support the safety of the Magnetic Navigation System... was reviewed" and that "The DSM adjudicated these events to be possibly and probably related to the procedure, respectively" in the VERSATILE study. This suggests that a Data Safety Monitoring board or similar expert body was involved in reviewing adverse events.

4. Adjudication Method for the Test Set

For the VERSATILE study, adverse events were "adjudicated" by the DSM (Data Safety Monitoring board). The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it indicates an expert review process.

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

No MRMC comparative effectiveness study is mentioned in the document. The comparative effectiveness assessment for the Genesis MNS is primarily against its predicate device (Niobe MNS) and historical clinical data for both the MNS system and manual ablation.

• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a robotic navigation system, not an AI-assisted diagnostic or interpretative device that augments human readers. The clinical studies compare outcomes of the magnetic navigation system to historical data or literature on manual ablation. The document states:
  • "More than 8,000 patients were reported in the literature using the MNS System with a major complication rate of 0.72% compared to a manual rate of 2.1%." (This implies a lower complication rate for MNS compared to manual.)
  • "Acute success rates and long-term success rates were similar in both the MNS and manual groups."

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

The device itself is a "Steerable Cardiac Ablation Catheter Remote Control System" and "Magnetic Navigation System," which is inherently designed for human-in-the-loop operation (a physician interacts with the user interface to control the magnetic field and system). Therefore, a standalone (algorithm only) performance study of the entire system as a diagnostic or interventional tool would not be relevant. The performance data presented focuses on the mechanical and electrical performance of the system and its clinical outcomes when used by an operator.

7. The Type of Ground Truth Used

The ground truth used for the clinical performance assessment consists primarily of:

• Clinical Outcomes Data: Major complication rates, acute success rates, and 90-day success rates, as recorded and adjudicated in the patient studies (ATTRAC, ATTRAC II, HEART, VERSATILE). These outcomes intrinsically serve as the "ground truth" for safety and efficacy in a clinical setting.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a robotic system, and its development would typically involve engineering design, bench testing, and clinical validation rather than a distinct machine learning training phase. The "data" used for demonstrating its safety and effectiveness are the results from the various tests (mechanical, electrical, animal, and clinical studies of the predicate device).

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

As there is no explicitly defined "training set" in the context of AI/ML, this question doesn't directly apply. The establishment of "ground truth" related to the device's design and operation would have been through engineering specifications, physics principles governing magnetic fields, and established clinical endpoints for cardiac ablation procedures (e.g., successful ablation, absence of major complications).

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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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