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NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Temporary prosthetic components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses.

NUVENTUS NV.C™ FINAL PROSTHETIC
NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.

The NUVENTUS NV.C™ Prosthetic Components product portfolio consists of NUVENTUS NV.C™ Healing Components, NUVENTUS NV.C™ Temporary Prosthetic Components, NUVENTUS NV.C™ Multi-unit Abutments, and NUVENTUS NV.C™ Final Prosthetic. NUVENTUS NV.C™ Prosthetic Components product portfolio are intended to be used with the NUVENTUS NV.C™ Dental Implant System (K233081).

NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ Healing Components may come in different designs, either with cap or screw portion machined as one piece or with an integrated occlusal screw. Different shapes, transmucosal heights are available. Healing components are components that cover the implant or abutment platform and prevent tissue overgrowth during the healing phase of the implant. The threaded portion of the healing components fits inside the internal threads of the implant or abutment, while the head of the healing components covers the top surface of the implant (the implant head) or abutment.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
The NUVENTUS NV.C™ Temporary Prosthetic Components line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are premanufactured dental abutments used for restoration of NUVENTUS NV.C™ Dental Implant of different diameters and lengths. The Multi-unit Abutments are available in NP and RP platform sizes; 0°, 17° and 30° angulations; various transmucosal heights and hexagonal index orientations. Multi-unit Abutments are co-packed with abutment carrier and screw. The abutments are delivered sterile for immediate use.

NUVENTUS NV.C™ FINAL PROSTHETIC
The NUVENTUS NV.C™ Final Prosthetic line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The provided FDA 510(k) Clearance Letter for NUVENTUS NV.C™ Prosthetic Components does NOT describe a device that uses AI or machine learning. It describes conventional prosthetic components for dental implants.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data, including:

• MRI Safety: Evaluation of components in an MR environment based on scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance.
• Sterilization Validation:
  • Gamma irradiation validation (25 kGy dose) for sterile components according to ISO 11137-1 and ISO 11137-2.
  • Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 (

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NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) Premarket Notification letter. This type of document is a submission seeking regulatory clearance, not a standalone study report. As such, it outlines the basis for demonstrating substantial equivalence to a predicate device, which includes non-clinical testing. It does not typically contain detailed acceptance criteria and performance data for a study proving a device meets those criteria in the way a clinical trial report or a comprehensive validation study would.

The document primarily focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. It refers to non-clinical tests that were performed, but does not present the specific acceptance criteria or the numerical results of those tests in a "performance table" format.

Therefore, many of the requested points below cannot be fully extracted from this document, as it's not the type of report that contains that level of detail for acceptance criteria and specific study outcomes. I will highlight what can be inferred or directly stated from the provided text, and what cannot.

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a detailed engineering validation report or a clinical study. Instead, it states that "non-clinical tests demonstrate that the device is substantial equivalent."

The document mentions several tests and standards the device was subjected to:

• Packaging system performance testing: per ASTM D4169. (Specific acceptance criteria and reported performance not detailed.)
• Dynamic loading testing: conducted according to ISO 14801 and FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)). (Specific acceptance criteria and reported performance not detailed.)
• Magnetic Resonance compatibility testing: according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Status: "MR Conditional." (This is a performance outcome, but the specific metrics and acceptance thresholds for each ASTM standard are not detailed.)
• Verification of biocompatibility: in accordance with ISO 10993-1. (The conclusion is that "no new issues regarding biocompatibility were raised," implying acceptance, but specific criteria and test results not detailed.)
• End user cleaning and sterilization validation: in accordance with ISO 17665-1. (Implied acceptance, but specific criteria and results not detailed.)

The "acceptance criteria" here are generally referred to as meeting the requirements of the standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is summarized as favorable results sufficient for substantial equivalence determination.

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

• Sample sizes: Not specified in the provided text for any of the non-clinical tests mentioned (packaging, dynamic loading, MR compatibility, biocompatibility, sterilization validation).
• Data provenance: Not explicitly stated (e.g., country of origin). The testing is non-clinical/bench testing, not patient data. It is implied to be internal testing by the manufacturer, Nobel Biocare AB (Sweden).
• Retrospective or prospective: N/A, as these are non-clinical/bench tests, not clinical studies involving patient data.

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

• Applicability: This question is not directly applicable to the type of non-clinical, bench testing described for the NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for AI/ML device evaluations, particularly in diagnostics. This document refers to physical device testing (mechanical, biocompatibility, etc.).

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

• Applicability: Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses for establishing "ground truth," which is not the nature of the non-clinical tests 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

• Applicability: Not applicable. This device is a dental abutment and screw, not an AI/ML-enabled diagnostic device for image interpretation. Therefore, no MRMC study or AI assistance evaluation would have been performed.

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

• Applicability: Not applicable. See point 5. This is a physical medical device, not a standalone algorithm.

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

• Applicability: The concept of "ground truth" as typically applied in AI/ML validation (e.g., for diagnostic accuracy) does not directly apply to the non-clinical device testing described. For these tests, the "ground truth" is typically defined by the specified parameters and performance requirements of the relevant international standards (e.g., ISO 14801 for dynamic loading, ISO 10993-1 for biocompatibility). The devices are expected to meet the performance criteria defined by these standards.

8. The sample size for the training set

• Applicability: Not applicable. This refers to the training of an AI/ML algorithm. The document describes a physical medical device.

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

• Applicability: Not applicable. See point 8.

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· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:

The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.

· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:

The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.

NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:

• NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
• -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base

The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:

a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration

b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design

The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.

NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.

The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).

The provided document is a 510(k) premarket notification for a dental device, specifically the NobelProcera® Zirconia N1™ Base and its associated Prosthetic Screw. The notification aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria or proving performance against novel criteria through clinical studies. Therefore, much of the requested information regarding a device meeting specific acceptance criteria and the nature of the study that proves it, as it would apply to a new classification or a device with new indications requiring extensive clinical validation, is not directly available or applicable in the provided context of a 510(k) submission for substantial equivalence.

However, I can extract information related to the performance data used to support substantial equivalence, which serves a similar purpose to demonstrating acceptance criteria in this regulatory pathway. The acceptance criteria here are implicitly alignment with the performance of the predicate and reference devices.

Here's a summary based on the provided text, addressing what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a quantitative table format that a device must meet to be considered "safe and effective." Instead, it focuses on demonstrating substantial equivalence by comparing its characteristics and performance to legally marketed predicate and reference devices. The "reported device performance" is primarily comparative in nature.

Implicit Acceptance Criteria (Demonstrated Equivalence) & Reported Performance:

Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Principle of operation, compatible Implant/Base platforms (NP/RP), device material (Ti6Al4V ELI), thread design, and screw interfaces (Omnigrip Mini) are the same as Reference Device No. 1. DLC coating applied to screw body, similar to Reference Device No. 1. Differences in screw body dimensions, anodization (subject device is not anodized), and packaging do not raise new concerns. |
| Performance (Non-clinical) | Performance as good as predicate/reference devices for intended use, as demonstrated by recognized standards (e.g., ISO 14801, ISO 10993-1, ASTM). | Fatigue Performance: Dynamic loading testing performed according to ISO 14801. Testing found acceptable, including evaluation of removal torque and no screw-loosening for run-out samples.
Biocompatibility: Demonstrated according to ISO 10993-1.
Wear Assessment: Light optical and SEM imaging following ISO 14801 fatigue loading showed similar wear patterns to reference device systems (NobelProcera® Zirconia Implant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746)).
Packaging System Performance: Tested per ASTM D4169.
Magnetic Resonance Compatibility: Tested according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Cleaning and Sterilization Validation: End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12. |
| Performance (Clinical/Real-World Evidence) | No evidence of new safety/effectiveness concerns with differences in materials or design. | Post-Market Surveillance (PMS) Data:

• NPr ASC Ab Zirconia CC (K132746): 8.1 years in patient, low complaint rates, no concerns regarding dissimilar materials (DLC-coated screw with Zirconia abutment).
• NobelProcera® Zr Implant Bridge (K202452): 1.7 years in patient, low complaint rates, no concerns regarding dissimilar materials.
  Clinical Data: Five clinical studies on NPr ASC Ab Zirconia CC (K132746) with mean follow-ups of 0.6-3.6 years, reporting on 277 devices. No reports of wear debris from Zirconia/DLC-coated screw contact or other adverse events raising concerns about dissimilar materials. A gap analysis was provided to support the relevance and reliability of this real-world evidence. |

2. Sample Size for the Test Set and Data Provenance

The document does not define a single "test set" in the context of a clinical trial for direct performance measurement. Instead, it refers to various non-clinical tests and real-world evidence.

• Non-clinical testing (Fatigue, Wear, MRI Compatibility, Packaging): The sample sizes for these specific tests are not provided in the summary. For example, ISO 14801 fatigue testing typically involves a certain number of samples (e.g., n=10-12 per group) but this detail is omitted.
• Real-World Evidence (PMS Data):
  • NPr ASC Ab Zirconia CC (K132746): Data collected from December 2013 up to January 2022. The longest time in a patient was approx. 8.1 years.
  • NobelProcera® Zr Implant Bridge (K202452): Data collected from May 2020 up to January 2022. The longest time in a patient was approx. 1.7 years.
  • Data Provenance: This is post-market surveillance data, likely originating from clinical use of the cleared predicate/reference devices, implicitly from various countries where Nobel Biocare products are marketed. It is retrospective in nature.
• Clinical Data (NPr ASC Ab Zirconia CC):
  • Sample Size: 277 NPr ASC Ab Zirconia CC (K132746) devices were reported across 5 clinical studies.
  • Data Provenance: The document states the studies were "included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study." The studies were published in international journals, suggesting prospective clinical studies from potentially diverse geographical origins, but specific countries are not mentioned (e.g., "[1] Greer, A.C., et al., Int J Prosthodont, 2017"). These are considered Real World Evidence in this submission.

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

This specific information is not provided in the document. For 510(k) submissions focusing on substantial equivalence, the "ground truth" for the test set is usually the performance of the predicate device as established by its clearance and recognized standards, rather than a new expert consensus process for the subject device. The clinical studies mentioned were about observing device performance in patients, not establishing a new ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective endpoints in clinical trials or for establishing ground truth from multiple expert readings (e.g., in AI/imaging studies). The provided clinical evidence references published studies with their own methodologies, which are not detailed here.

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

No, an MRMC comparative effectiveness study was not done. The studies cited are focused on the clinical performance and safety of existing devices (predicates/references) and a "gap analysis" for using that as real-world evidence for the subject device, or non-clinical engineering tests. There is no mention of comparing human readers with and without AI assistance.

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

This question is not applicable as the device is a physical dental abutment and prosthetic screw, not an AI algorithm or software. Therefore, there is no "standalone" performance in the context of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is primarily:

• Engineering Standards: Compliance with ISO 14801, ISO 10993-1, ASTM F2052, F2213, F2119, F2182, ISO 17665-1, AAMI TIR12.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate and reference devices (On1 Concept K161655, N1™ TiUltra™ TCC Implant system K211109, NobelProcera Angulated Screw Channel Abutment Conical Connection K132746, Nacera Pearl K143071).
• Outcomes Data/Real-World Evidence: Post-market surveillance data and clinical study outcomes for the predicate/reference devices, showing low complaint rates, good tissue health, and no unexpected adverse events related to material interactions. These outcomes serve as a proxy for acceptable performance.

8. The Sample Size for the Training Set

This concept is not applicable as the device is a physical dental component and not an AI/machine learning model that undergoes a "training" phase with a dataset.

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

This question is not applicable for the same reason as point 8.

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The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients. The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14 units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NobelProcera HT ML FCZ Implant Bridge and Framework:

The document is a 510(k) premarket notification summary for a dental implant bridge and framework. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with performance criteria requiring a complex clinical study. Therefore, many of the requested categories (like MRMC studies, ground truth for training sets, etc.) are not applicable or not detailed in this type of submission.

Acceptance Criteria and Study for NobelProcera HT ML FCZ Implant Bridge and Framework

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Fatigue Testing: Not explicitly stated. The document mentions "the subject and predicate device were tested," implying a comparative, laboratory-based study. However, the number of units tested for fatigue is not given.
• Data Provenance: The studies were laboratory-based performance tests, not human data. The exact location of the testing laboratories is not specified, but the manufacturer (Nobel Biocare AB) is based in Sweden, and the submission is from their US entity.

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

• This question is not applicable as the studies conducted were performance testing of the device's physical properties and biocompatibility, not studies involving human interpretation or clinical outcomes requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as (3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was used to support the decision of substantial equivalence." This type of study would involve human readers (e.g., dentists, prosthodontists) evaluating cases with and without the device, which was not performed or submitted.

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

• This question is not applicable. The device is a physical dental implant bridge and framework, not an algorithm or AI system.

7. The Type of Ground Truth Used

• This question is not applicable in the traditional sense for these types of engineering and biocompatibility tests. The "ground truth" for these tests would be the established scientific and engineering principles and the specified values/limits within the ISO standards themselves. For example, for fatigue, the "truth" is the device's actual fatigue life as measured objectively under controlled conditions, compared against the predicate's measured fatigue life and relevant industry standards.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not an AI/ML algorithm development.

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

• This question is not applicable for the same reasons as (8).

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