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The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for the StimRouter Neuromodulation System's permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.

The StimTrial Neuromodulation System is to be used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant for a system indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain of craniofacial nerve origin.

The StimTrial Neuromodulation System is intended to help determine patient candidacy for a permanent implant to help manage pain of peripheral nerve origin. The StimTrial System works by sending electrical impulses from an external stimulator to a lead that is percutaneously placed next to a target nerve. These impulses are intended to interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.

The StimTrial Neuromodulation System consists of three main parts - the percutaneous StimTrial Lead, the StimTrial Lead Adaptor Cable, and the StimTrial External Stimulator. The StimTrial Lead is percutaneously placed with the distal, stimulating end located at or near the targeted peripheral nerve and with the proximal end remaining outside of the body for the trial duration. The StimTrial Lead Adaptor Cable is an external cable that directly connects the StimTrial Lead to the StimTrial External Stimulator providing a direct electrical pathway from the External Stimulator to the Lead. The StimTrial External Stimulator is a device which, when connected to the Lead Adaptor Cable and the StimRouter Electrode (a hydrogel patch electrode) attached to the skin near the implant site, generates electrical stimulation pulses that travel to the StimTrial Lead. Accessories for the StimTrial System include the StimRouter Electrode (a disposable electrode patch, cleared most recently in K211965), the StimTrial Clinician Programmer with Software (CPS) and the optional StimTrial Mobile Application (MAPP) installed on a Smartphone.

The StimTrial System incorporates both commercially available and specially designed components. The materials used in the StimTrial Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the StimTrial System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.

This document outlines the acceptance criteria and the study conducted to prove that the StimTrial Neuromodulation System meets these criteria, based on the provided FDA 510(k) Clearance Letter.

Summary of Device Performance Study Information:

The provided document details various performance tests conducted for the StimTrial Neuromodulation System, but it does not include a clinical study with specific acceptance criteria and reported performance metrics in the format typically used for demonstrating efficacy or performance against a clinical endpoint (e.g., accuracy, sensitivity, specificity, or improvement in patient outcomes).

Instead, the listed "Performance Testing" are focused on engineering, safety, and regulatory compliance aspects:

• Labeling Validation
• Software verification and validation (for External Stimulator, MAPP and CPS software devices)
• EMC, Wireless Co-Existence and Electrical Safety
• Usability testing (for Implanting Physician, Treating Clinician and Patient)
• Bench testing (Tests of the StimTrial Lead, External Stimulator, StimTrial System)
• Animal testing (Acute and Long-term studies in porcine animal model)
• Sterilization and Shelf Life (StimTrial Surgical Kit)
• Biocompatibility (for StimTrial Lead, Insertion Tools and External Stimulator)

This type of submission for a Class II device like a neuromodulation system for trial stimulation often relies heavily on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The purpose of this "StimTrial System" is for trial stimulation to determine efficacy before a permanent implant, meaning its primary function in this context is to safely and effectively deliver electrical stimulation within defined parameters to aid in patient selection for a long-term device. It is not an AI/ML powered device, so many of the questions regarding ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not directly applicable in the typical sense of an AI/ML performance study.

Given the information, a detailed table of "acceptance criteria and reported device performance" related to clinical efficacy or AI/ML performance metrics cannot be constructed from the provided text. The "acceptance criteria" for a 510(k) clearance in this context primarily revolve around demonstrating that the device is as safe and effective as its predicate devices, which is achieved through the enumerated non-clinical tests and technical comparisons.

However, answering the questions as best as possible based on the implied purpose of such a device and the provided text:

Implied Acceptance Criteria and Study to Prove Device Meets Criteria (Based on information provided)

The "StimTrial Neuromodulation System" is a medical device for trial stimulation. Its acceptance criteria are implicitly tied to demonstrating safety and performance characteristics that are substantially equivalent to legally marketed predicate devices, as this is a 510(k) submission. The study proving this typically involves a combination of bench testing, software validation, biocompatibility, and animal studies, rather than large-scale clinical trials for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document focuses on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than clinical performance metrics, a table of "acceptance criteria" for a clinical outcome (e.g., sensitivity, specificity, accuracy) is not present. The acceptance criteria relate to meeting specific engineering, safety, and biocompatibility standards, and these are largely reported as successful completion of the tests mentioned in Section VII.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for performance evaluation (e.g., accuracy of diagnosis). The "tests" performed are largely engineering validations or animal studies.
  • For Animal Testing, "Acute and Long-term studies in porcine animal model" were conducted. The specific number of animals is not stated.
  • For Usability Testing, the number of "Implanting Physician, Treating Clinician and Patient" participants is not specified.
  • For Bench Testing, the number of units or tests performed is not specified, but it implies a sufficient number to validate performance.
• Data Provenance: Not explicitly stated for any clinical data as it's not a clinical performance study. Animal studies are typically conducted in a controlled lab environment.

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

Not applicable in the typical sense of AI/ML ground truth establishment. The "ground truth" for this device's performance would be established by objective measurements in bench testing (e.g., output electrical parameters matching specifications), and pathological/physiological observations in animal models (e.g., tissue response). These are based on established engineering and biological standards, not human expert consensus on interpretations of images or signals.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of human-interpreted data that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:

Not applicable. This device is a neuromodulation system, not an AI/ML algorithm for diagnostic or prognostic purposes, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical neuromodulation system with accompanying software for control, not a standalone algorithm for independent task execution (like image analysis). Its function inherently involves human-in-the-loop operation (clinician programming, patient use).

7. The Type of Ground Truth Used:

The "ground truth" for the various performance tests would be:

• Bench Testing: Engineering specifications and physical measurements (e.g., electrical parameter values, mechanical properties).
• Biocompatibility: ISO standards for medical device materials.
• Sterilization: Sterility assurance levels (SAL) based on validated methods.
• Animal Testing: Histopathological analysis of tissues, physiological responses, and adverse event monitoring.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a machine learning component that requires a "training set" in the conventional sense.

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

Not applicable, as there is no training set for an AI/ML model.

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The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

The TalisMann Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the pain management of adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

The TalisMann Neuromodulation System works by providing electrical impulses to a target area in the body. These impulses may interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.

The TalisMann Neuromodulation System consists of three main parts – the implantable StimRouter Lead (cleared most recently in K211965), the implantable TalisMann Pulse Generator/Receiver that is connected to the implantable Lead, and the external (to the body) components. The Lead is implanted with the stimulation end located at or near the targeted peripheral nerve, whereas the end with the Pulse Generator/Receiver is located near the skin surface. Accessories for the TalisMann include the Clinician Programmer with Software (CPS), the optional Mobile Application (MAPP) installed on a SmartPhone, the StimRouter Electrode (a disposable electrode patch, cleared most recently in K221965), and the TalisMann External Electrical Field Conductor (E-EFC).

The TalisMann System incorporates both commercially available and specially designed components. The materials used in the TalisMann Pulse Generator/Receiver and Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the TalisMann System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.

The TalisMann uses the following components unchanged from the StimRouter System (K211965): the StimRouter Lead, the MAPP software, the E-EFC, and the StimRouter (Hydrogel Patch) Electrodes. The new components of the TalisMann System are: the TalisMann Pulse Generator/Receiver, new implant tools, and the updated Clinician Programmer Software (updated to enable TalisMann parameters).

The provided FDA 510(k) clearance letter and summary for the TalisMann Neuromodulation System does not contain the detailed acceptance criteria or a study proving that the device meets specific performance criteria in terms of accuracy, precision, or clinical efficacy.

The document primarily focuses on establishing substantial equivalence to predicate devices by comparing technological characteristics and listing the types of performance testing conducted for safety and effectiveness. It does not provide quantitative acceptance criteria for device performance nor the results of studies that would demonstrate the device meets such criteria.

The information provided confirms that the device underwent various forms of testing to demonstrate safety and general performance characteristics relative to its predicates, but not specific performance metrics such as accuracy or efficacy in pain relief that would typically have acceptance criteria.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis of what information is available and what is missing:

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

• Not provided. The document does not specify quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in pain, or a certain accuracy for a diagnostic component). It focuses on direct comparisons of design and general safety/electrical parameters to predicate devices.

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

• Not provided for human clinical studies demonstrating efficacy.
• Animal Testing: Mentioned as "Acute and Long-term studies in porcine animal model" but sample size is not specified.
• Provenance: Not specified for any potential clinical data, as no clinical efficacy data is detailed.

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

• Not applicable/Not provided. The document discusses performance testing for safety, electrical characteristics, software validation, and usability. It does not describe a test set requiring expert-established ground truth for a diagnostic or efficacy claim. Usability testing involved "Implanting Physician, Treating Clinician and Patient" but specific numbers or qualifications are not given.

4. Adjudication method for the test set

• Not applicable/Not provided. No adjudication method is mentioned as there isn't a stated clinical efficacy or diagnostic performance study requiring ground truth establishment through expert review.

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 device is a neuromodulation system for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study is not relevant and was not conducted.

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

• Not applicable. This device is an implanted neuromodulation system used by a patient, with programming by a clinician. It's not an algorithm that performs a standalone function without human interaction in its therapeutic application. Software verification and validation were performed for the E-EFC, MAPP, and CPS, which are components of the system, but this is a different type of "standalone" than algorithm performance.

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

• Not explicitly stated for efficacy/clinical performance. For safety and engineering tests, the "ground truth" would be established engineering standards, biocompatibility testing results, and functional requirements. For software, it would be validation against specified requirements. No specific clinical outcomes data or pathology as a "ground truth" for device efficacy is mentioned in the context of performance criteria.

8. The sample size for the training set

• Not applicable/Not provided. The device is not described as involving machine learning or AI models that would require a "training set" in the traditional sense for an algorithmic performance claim.

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

• Not applicable/Not provided. (See point 8).

Summary of what is present:

The document outlines a substantial equivalence argument based on:

• Comparison of Indications for Use: Similar to predicates for severe intractable chronic peripheral nerve pain, excluding craniofacial region.
• Comparison of Technological Characteristics: Detailed tables comparing the subject device (TalisMann Neuromodulation System) to three predicate devices (StimRouter, Nalu, Renew) across components like transmitter/receiver, leads, externally worn devices, clinician programmer, and patient remote control. These comparisons highlight similarities in mode of action, implant site, power sources, stimulation parameters (frequency, duration, charge, power), materials, and software configuration.
• Performance Testing Categories: A list of testing performed to support safety and effectiveness, including:
  • Labeling Validation
  • Software verification and validation (for E-EFC, MAPP, and CPS)
  • EMC, Wireless Co-Existence, and Electrical Safety
  • Usability testing (for Implanting Physician, Treating Clinician, and Patient)
  • Bench testing (TalisMann implant, external modules, system testing)
  • Animal testing (Acute and Long-term studies in porcine model)
  • Sterilization and Shelf Life
  • Biocompatibility

Conclusion based on the provided text:

The FDA 510(k) clearance letter focuses on establishing substantial equivalence for the TalisMann Neuromodulation System by demonstrating that its technological characteristics, intended use, and performance testing (with a focus on safety and established engineering principles) are comparable to legally marketed predicate devices. It does not present a study with specific, quantitative acceptance criteria for clinical performance or efficacy metrics against which the device's performance is measured and reported. The "performance testing" described is primarily geared towards validating individual components and system safety/functionality rather than an overarching clinical effectiveness study with defined endpoints and acceptance criteria in the context often seen for diagnostic or AI-driven devices.

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The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.

The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula.

The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.

The provided document is a 510(k) summary for the Allograft Delivery Device (OFAC-C), which is a medical device and not an AI/ML-driven software. Therefore, the document does not contain information typically associated with AI/ML device testing and acceptance criteria, such as diagnostic performance metrics (e.g., sensitivity, specificity, AUC), clinical study designs (e.g., MRMC studies), ground truth establishment by experts, or training/test set details for AI algorithms.

The acceptance criteria and supporting studies presented in this document are focused on the physical and biological performance of a medical device (a delivery syringe), not an AI algorithm. The performance data provided relates to:

• Sterilization and Shelf-life: Validation that the device remains sterile and functional over time.
• Biocompatibility Testing: Confirmation that the device materials are safe for human contact.
• Functional Verification: Mechanical tests to ensure the device operates as intended (e.g., cannula buckling, plunger force, connection strength, no fluid separation, durability, push rod function).
• Shipping/Transit: Testing to ensure the device withstands transport conditions.
• Usability Testing: Evaluation of how easily and effectively users can safely operate the device.

Since the request asks for details specific to AI/ML device evaluation, and this document pertains to a physical medical device, I cannot extract the requested information. The document does not describe:

1. A table of acceptance criteria for AI performance or reported device AI performance.
2. Sample sizes for AI test sets or data provenance for AI.
3. Number/qualifications of experts for AI ground truth.
4. Adjudication method for AI ground truth.
5. MRMC studies or effect sizes of human reader improvement with AI.
6. Standalone AI algorithm performance.
7. Type of ground truth for AI (e.g., pathology, outcomes data).
8. Sample size for AI training set.
9. How AI training set ground truth was established.

Therefore, I must state that the provided text does not contain the information required to answer your query regarding AI/ML device acceptance criteria and study details.

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SIGNAFUSE Bioactive Strip (SBS) is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.

The provided text is a 510(k) summary for medical devices (SIGNAFUSE Bioactive Strip (SBS) and SIGNAFUSE Putty), focusing on their substantial equivalence to predicate devices and an expanded indication for use in the intervertebral disc space.

Based on the information provided, it states that:

• No new acceptance criteria or clinical studies (beyond leveraging previous clearances and providing clinical rationale) were conducted for this specific 510(k) submission regarding device performance metrics in the way one might expect for a novel AI device or a new clinical endpoint.
• The performance assessment for this submission relies heavily on previous clearances (K193513 and K132071), which established the device's sterility, shelf-life, endotoxin, biocompatibility, and characterizations/bench performance.
• The expanded indication for use in the intervertebral body space was supported by a "clinical rationale of bone grafting materials in the intervertebral space," rather than a new clinical study with defined acceptance criteria and performance data for this specific submission.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets these criteria, sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for this specific submission is not present in the provided document.

The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of a new clinical performance study for an AI/software as a medical device (SaMD) or a new physical device requiring novel clinical endpoint demonstration. The 'performance' section refers to leveraging previously established data and providing a clinical rationale, not new trials to meet defined (and quantified) acceptance criteria for efficacy or diagnostic performance.

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MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided document is a 510(k) summary for the MCS Bone Graft device. It describes the device, its intended use, and provides a summary of performance testing and substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study description with sample sizes, or information on human reader studies (MRMC or standalone), which are typically associated with artificial intelligence/machine learning devices. The MCS Bone Graft is a medical device, specifically a bone graft substitute, and its evaluation focuses on biocompatibility, material properties, and in-vivo animal studies, not AI performance.

Therefore, the requested information cannot be fully extracted from the provided text in the context of an AI/ML device. I will answer based on the information that is present about the MCS Bone Graft as a physical medical device.

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

The document does not specify quantitative acceptance criteria in a table format, nor does it present device performance in terms of metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, it refers to compliance with standards and successful outcomes in animal studies.

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: The document mentions a "critical-size rabbit femoral defect study" and a "rabbit posterolateral spine fusion study." It does not specify the exact number of animals used in these studies.
• Data Provenance: The studies are animal studies (rabbits), specifically in vivo performance testing. There is no information on the country of origin of the data or whether it was retrospective or prospective, though animal studies are typically prospective by nature.

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

This information is not applicable to this device submission. The MCS Bone Graft is a physical medical device, not an AI/ML diagnostic tool. Ground truth was established through scientific methods such as radiographic, microCT, biomechanical, and histological endpoints in animal models, not by human expert assessment of AI output.

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

This information is not applicable. The device is a bone graft substitute, and its performance evaluation does not involve human adjudication of diagnostic outputs.

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 relevant for AI/ML diagnostic devices where human readers interpret medical images with or without AI assistance. The MCS Bone Graft is a therapeutic bone graft substitute.

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

No, a standalone performance study (algorithm only) was not done. This is not relevant for a physical bone graft device.

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

For the animal in vivo performance testing, the ground truth was established using:

• Radiographic endpoints
• MicroCT (micro-computed tomography) endpoints
• Biomechanical endpoints
• Histological endpoints (examination of tissue microstructure)

8. The sample size for the training set

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

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

This information is not applicable, as there is no training set for this type of medical device.

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