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Montblanc Radius Plate System

The Montblanc Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.

Montblanc Ankle Plate System

The Montblanc Ankle Plate System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the distal tibia and fibula.

The Montblanc Plate System consists of a series of plates and screws of varying lengths and orientations with Montblanc Radius Plate System and Montblanc Ankle Plate System. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as non-sterile, single-use.

The FDA 510(k) clearance letter for the Montblanc Plate System does not contain information about a study proving the device meets acceptance criteria related to AI/software performance. The provided document is for a mechanical bone fixation device (plates and screws), not an AI-powered diagnostic or assistive technology.

Therefore, many of the requested fields are not applicable to this type of medical device and its clearance process. The performance tests mentioned in the document are mechanical and material property tests for the physical plate and screw components, not software-based algorithms.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Device Type: Montblanc Plate System (Single/multiple component metallic bone fixation appliances and accessories - plates and screws for fractures)

Nature of Device Performance Evaluation in 510(k): For this device, the "performance" evaluated by the FDA relates to the physical and mechanical properties of the plates and screws (e.g., strength, stiffness, resistance to forces) to ensure they can effectively fix bone fractures. It does not involve an AI algorithm or software for diagnosis or assistance, nor does it require human reader studies, ground truth establishment by experts, or training/test sets for AI.

Information from the Provided Document:

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

The document mentions that performance tests were conducted in accordance with manufacturer SOP, FDA guidance, ASTM F382 (Standard Specification for Metallic Bone Plates), and ASTM F543 (Standard Specification for Metallic Medical Bone Screws). It specifies:

Note: The document states, "We believe that the performance test acceptance criteria is appropriate and that each test result ensure the effectiveness of Montblanc Plate System for the indications for use provided by the manufacturer and supports substantial equivalence." This statement implies that the device met the established acceptance criteria for these mechanical tests.

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

• Sample Size: The document mentions "Plates with the smallest cross-sectional area of the critical region of the device" and "Screws with the smallest cross-sectional area of the critical region of the device and longest length," and "Screws with the smallest cross-sectional area of the critical region of the device and shortest length" were chosen as worst-case samples. This suggests a limited, targeted number of physical samples for testing, focused on representative "worst-case" configurations to demonstrate mechanical robustness. It does not refer to a data set in the context of AI.
• Data Provenance (Country of Origin): Not specified for the tests, but the applicant (Medifield Medical Co., Ltd.) is from Korea, South.
• Retrospective or Prospective: Not applicable, as these are engineering/mechanical bench tests on physical devices.

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

• Not Applicable. This is a mechanical device, not an AI system requiring expert-established ground truth from medical images/data. The "ground truth" for mechanical properties is established by engineering standards (ASTM) and internal specifications.

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

• Not Applicable. No human reader adjudication is involved in the mechanical testing of bone plates and screws.

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 mechanical implant, not an AI-assisted diagnostic tool. No human reader studies or comparisons with AI assistance were performed.

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

• Not Applicable. There is no algorithm or software component to evaluate in a standalone manner for this device.

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

• Mechanical Engineering Standards and Specifications. For this type of device, the "ground truth" for performance is defined by adherence to established mechanical testing standards (e.g., ASTM F382, ASTM F543) and the manufacturer's own design specifications, which are based on biomechanical requirements for bone fixation.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not Applicable. As there is no training set for AI, no ground truth needed to be established for it.

Summary of Key Takeaway:

The provided document describes the FDA 510(k) clearance for a mechanical medical device (bone plates and screws). The "acceptance criteria" and "study" proving the device meets these criteria refer to physical and mechanical bench testing against engineering standards, not to the performance of an artificial intelligence algorithm or software. Therefore, most of the questions related to AI performance metrics, data sets, expert review, and ground truth establishment from medical data are not relevant to this particular 510(k) submission.

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APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.

APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.

The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.

The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.

The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.

All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.

This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML-powered device. Therefore, the sections for AI/ML-specific criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable and cannot be extracted from the provided text.

The document discusses acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to predicate devices, which is common for traditional medical devices under 21 CFR 888.3030.

Here's an analysis based on the available information:

Acceptance Criteria and Study to Prove Device Meets Criteria

The acceptance criteria for this medical device (APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System) are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, primarily K142906, APTUS® Wrist 2.5 System, and reference devices K000684, K103332, and K151468. The study aims to show that the new device is as safe and effective as these predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and mechanical testing of the device itself and comparison to predicates, not a "test set" of patient data for an AI/ML algorithm.

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 an AI/ML algorithm's test set is not relevant here. The "ground truth" for this submission is demonstrating that the device meets defined engineering specifications and is substantially equivalent to existing, safe, and effective devices.

4. Adjudication method for the test set

Not applicable. There is no AI/ML test set 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

No. This is not an AI-assisted device.

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

No. This is not an AI/ML algorithm.

7. The type of ground truth used

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

• Established engineering standards: ASTM F382 for mechanical testing.
• Regulatory compliance: Adherence to 21 CFR 888.3030.
• Comparison to predicate devices: Demonstrating similar intended use, technological characteristics, materials, dimensions, and performance as devices already cleared by the FDA. This implicitly means the predicate devices' safety and efficacy, established through their own clearance processes, serve as a reference.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Humerus System is consists of plates and screws. The ARIX Humerus System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium- 6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts and depth gauge. It also includes various manual surgical instruments, such as hand body, driver, drill bits, depth gauge, drill sleeve, forceps, drill guide block, sleeve handle and drill guide. The ARIX Humerus System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery.

This document is a 510(k) premarket notification for the ARIX Humerus System, a medical device for bone fixation. It does not describe a study involving device performance in terms of diagnostic accuracy or effects on human readers. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/human reader performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and mechanical performance (bench testing), rather than clinical performance (e.g., diagnostic accuracy, reader improvement).

Here's why I cannot provide the specific details requested:

• Type of Device: The ARIX Humerus System is a metallic bone fixation appliance (plates and screws). It is a surgical implant, not a diagnostic imaging device or an AI-powered image analysis tool.
• Study Purpose: The studies mentioned (bench tests per ASTM F382 and F543) are mechanical performance tests designed to ensure the device's strength and fatigue resistance are equivalent to existing devices, not to evaluate diagnostic accuracy or how it impacts human interpretation of medical images.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are related to mechanical and material properties (e.g., bending strength, fatigue life, biocompatibility) rather than diagnostic metrics like sensitivity, specificity, or AUC.
• Lack of AI/Reader Involvement: There is no mention of AI integration, human readers interpreting images, or any comparative effectiveness study involving human performance with and without AI assistance.

However, I can extract the information that is present in the document related to general device performance and regulatory requirements:

1. A table of acceptance criteria and the reported device performance (based on mechanical testing mentioned):

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

• The document does not specify sample sizes for mechanical testing. These tests are typically performed on a limited number of physical samples (e.g., plates and screws) to demonstrate compliance with standards.
• Data provenance is not specified beyond being "bench tests." These are laboratory tests, not clinical data from patients.

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

• Not applicable. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy.

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

• Not applicable. This is not a study involving human reader interpretation.

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

• No MRMC study was done. This is not an AI-assisted diagnostic device.

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

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

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

• For the mechanical tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices or relevant ASTM standards.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning algorithms requiring training sets.

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

• Not applicable.

In summary, the provided document describes a 510(k) submission for a surgical implant, not an AI-powered diagnostic device. Therefore, questions related to AI performance, human reader studies, and diagnostic accuracy are not relevant to this document.

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The ARIX Foot System (2.3/2.8) is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusion, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System (2.3/2.8) is rigid fixation consisting of plates and screws in various confiqurations, shapes and sizes. The ARIX Foot System (2.3/2.8) is made of Unalloyed Titanium and Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws, locking screws & self-drilling screws are provided with diameter 2.0 mm to 2.8 mm and lengths from 6 mm to 46 mm.

The provided document is a 510(k) premarket notification for a medical device called the "ARIX Foot System (2.3/2.8)". This notification focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and bench testing, rather than reporting on the performance of an AI-powered diagnostic device or a study involving human readers.

Therefore, many of the requested categories for AI/diagnostic device performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment methods, are not applicable to this document. The document explicitly states: "No clinical studies were considered necessary and performed."

However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical testing performed.

Here's the breakdown, focusing on the information available:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical values or ranges. Instead, it states that the device complies with recognized standards for metallic bone plates and screws. The reported device performance is that the "results of this testing indicate that the ARIX Foot System (2.3/2.8) is equivalent to predicate device."

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

• Sample size for test set: The document does not specify the exact number of plates or screws tested for each non-clinical test. It generally refers to "bench tests" being conducted.
• Data provenance: The tests were conducted by Jeil Medical Corporation, located in Seoul, Korea. The data is prospective in the sense that these were specific tests performed for this submission, not analysis of existing data.

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

This is not applicable. The "ground truth" for mechanical testing is based on engineered specifications and industry standards (ASTM standards), not human expert interpretation.

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

This is not applicable. Adjudication methods are relevant for interpreting subjective assessments or diagnoses, not for objective mechanical tests.

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 device is a metallic bone fixation system, not an AI-assisted diagnostic tool.

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

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

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

The "ground truth" in this context is defined by the established mechanical properties required by the ASTM standards (ASTM F382 and ASTM F543) and the observed performance of the predicate devices. It is a technical ground truth based on engineering specifications and material science, not a medical "ground truth" for diagnosis.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This is not applicable for the reasons mentioned above.

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The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.

The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The plates are Medial Type and Anterolateral Type and T Type. The screws are Cortical Screw (28-SO-L Series, 35-SO-L Series) and Locking Screw (28L-SO-L Series, 35L-SO-L Series). The system is made of ASTM F 136, Titanium Alloy (Ti-6Al-4V). The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 80 mm. The system is provided as Gold color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surgical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle. The ARIX Ankle Distal Tibia System is not provided sterile.

This document, K170313, describes the ARIX Ankle Distal Tibia System, a bone plate and screw system intended for fixation of intra- and extra-articular fractures and osteotomies of the distal tibia.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Bending strength test per ASTM F382-14
• Bending fatigue test per ASTM F382-14 | The test results for bending strength and bending fatigue for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
  | Screws:
• Driving torque test per ASTM F543-13
• Torsion test per ASTM F543-13
• Axial pull out test per ASTM F543-13 | The test results for driving torque, torsion, and axial pull out for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
  | Biocompatibility: Meet ASTM F136 for Titanium Alloy (Ti-6Al-4V) | Device material (ASTM F 136, Titanium Alloy) is widely used for surgical implants with well-known biocompatibility. (Page 5) |
  | Sterilization: Achieve a SAL of 10^-6 via autoclave, validated per ISO 17665-1: 2006 | Sterilization method validated per ISO 17665-1: 2006. (Page 5) |

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for specific tests. The document refers to "bench tests" performed using the "proposed device" and "predicate device." It doesn't specify the number of plates or screws tested for each mechanical test.
• Data Provenance: The study is a non-clinical bench test conducted to verify design specifications and compliance with ASTM standards. The provenance is internal testing performed by the manufacturer or a contracted lab. There is no mention of country of origin for the data itself, but the manufacturer is Jeil Medical Corporation in Korea. This is a retrospective analysis in the sense that the testing was performed to support the 510(k) submission, not as a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This submission is for a medical device (bone fixation system) and relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device, not on diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication Method

• Not Applicable. As no expert review or clinical diagnosis is involved in the acceptance criteria, there is no adjudication method.

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

• No. The document explicitly states: "No clinical studies were considered necessary and performed." This means no MRMC study was conducted.

6. Standalone Performance Study

• Yes, a form of standalone performance was done for the device itself. The bench tests (bending strength, fatigue, driving torque, torsion, axial pull-out) assess the mechanical performance of the ARIX Ankle Distal Tibia System independently, comparing it to established standards and a predicate device. This is "standalone" in the sense that the mechanical behavior of the device components is evaluated without human interaction during the test, beyond setting up the experiment.

7. Type of Ground Truth Used

• Standardized Mechanical Performance Metrics / Predicate Device Performance. The "ground truth" for the acceptance criteria and performance evaluation is based on:
  • Compliance with recognized international standards (ASTM F382-14 for plates, ASTM F543-13 for screws).
  • Demonstration of equivalent mechanical performance to a legally marketed predicate device (Synthes LCP Distal Tibia Plates - K013248).

8. Sample Size for Training Set

• Not Applicable. This is a medical device (bone fixation system) and not an AI/ML diagnostic algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process are informed by established engineering principles and material science, not by training on a dataset.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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The ARIX Diaphysis System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The ARIX Diaphysis System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Diaphysis System is made of Unalloyed Titanium and Titanium Alloy (Ti-6Al-4V). The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 3.5 mm and lengths from 10 mm to 100 mm.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical bench testing. Therefore, there are no human subject test sets or associated data provenance (e.g., country of origin, retrospective/prospective). The "test set" in this context refers to the physical devices (plates and screws) subjected to mechanical testing. The sample size for these tests is not explicitly stated in numerical terms (e.g., "n=X plates," "n=Y screws"), but the phrase "The following tests were performed with the predicate device" implies a comparison between the subject device and the predicate device for each test.

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

Not applicable. This was a non-clinical bench study. The "ground truth" for mechanical testing is established by the ASTM standards and the measured physical properties of the devices. No human experts were used to "establish ground truth" in the way they would for medical image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple experts or consensus for the "test set" in the context of human data. The compliance was determined by objective measurements against established engineering standards.

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

No. The document explicitly states: "No clinical studies were considered necessary and performed." This study is a non-clinical bench study focused on mechanical performance and equivalence to predicate devices, not a clinical trial involving human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device (bone fixation system), not an algorithm or AI software. Therefore, there is no "standalone algorithm only performance" to assess.

7. Type of Ground Truth Used

The "ground truth" for this study was engineering standards and mechanical test results. Specifically:

• ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates)
• ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws)
• Comparative mechanical properties (e.g., torsional strength, pull-out strength, bending, fatigue) relative to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a medical device and not an AI or machine learning system that requires a "training set."

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

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

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