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NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process.

NanoBone® QD Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD Putty resorbs and is replaced with bone during the healing process.

NanoBone® SBX Putty consists of NanoBone® granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone. NanoBone® SBX Puttv does not set in-situ following implantation.

NanoBone® SBX material is supplied in two different style applicators. The NanoBone® SBX Putty is supplied in a sterile applicator with an attached plunger. NanoBone® QD is an alternate packaging of the NanoBone® SBX Putty. NanoBone® OD is supplied in a sterile cartridge with a separate sterile plunger.

This document is an FDA 510(k) premarket notification for a medical device called NanoBone® SBX PUTTY and NanoBone® QD. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results typical for new, complex AI/software devices.

As such, the information required to fully answer your request regarding acceptance criteria and performance studies (especially for an AI/software device) is not present in this document. The device in question is a bone void filler, a physical implant, not an AI-powered diagnostic or assistive tool.

Therefore, I cannot provide a detailed response for many of your points, particularly those related to AI/software performance, reader studies, and AI-specific ground truth establishment.

However, I can extract the information relevant to this specific device (a bone void filler) where available.

Here's a breakdown based on the provided text, addressing your questions to the best of what's available and noting what is not applicable (N/A) for this type of device:

Device: NanoBone® SBX PUTTY, NanoBone® QD (Bone Void Filler)
Regulation Number: 21 CFR 888.3045 (Resorbable calcium salt bone void filler device)
Regulatory Class: Class II
Product Code: MQV

Summary of Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing/Performance Data"):

The document states that previous bench testing (for the predicate device) and additional animal testing (for the subject device's expanded indication) were performed. The acceptance criteria are broadly described as meeting "all relevant requirements for calcium salt bone void filler devices, including ASTM F1185." The performance is summarized as "demonstrated that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices."

Detailed Table of Acceptance Criteria and Reported Device Performance:

• Phase purity / XRD performed.
• Dissolution testing performed. |
  | Biocompatibility | Verified to be safe for biological use. | - Biocompatibility assessment / testing performed.
• Verified to be the same as predicates due to identical materials. |
  | Sterilization & Packaging | Ensuring sterility and shelf-life integrity. | - Sterilization validation (Radiation) performed, matching predicate.
• Shelf life testing performed.
• Pyrogenicity testing performed. |
  | Functionality/Performance (In vitro & In vivo) | Functioning as intended (filling bony voids, resorption, replacement with bone). | - In vitro bench tests demonstrated that the NanoBone® bone graft substitutes met all acceptance criteria and performed similarly to the predicate devices.
• Additional animal testing performed to show performance for use in posterolateral fusion. |
  | Safety and Effectiveness Profile | Similar safety and effectiveness profile to legally marketed predicate devices. | - Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices. The NanoBone® SBX Putty and NanoBone® QD are substantially equivalent to the predicate. |

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

• Sample Size for Test Set: Not specified in terms of number of cases for a clinical "test set." The testing mentioned is primarily non-clinical: "bench testing" and "animal testing." No human clinical trial data is presented for this 510(k).
• Data Provenance:
  • Country of Origin: Not explicitly stated for specific test data, but the applicant is ARTOSS GmbH, located in Rostock, Germany.
  • Retrospective or Prospective: N/A, as it's non-clinical testing.

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

• N/A. As a physical implant (bone void filler), the "ground truth" is established through laboratory analyses, animal studies, and comparison to existing predicate devices' known performance, not through expert human reader interpretation of images or clinical outcomes in the same way an AI device would require.

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

• N/A. Adjudication methods like 2+1 or 3+1 are used in consensus reading for image interpretation or clinical diagnosis, which is not relevant to the testing of a bone void filler material.

4. 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:

• N/A. This device is a physical bone void filler, not an AI software. Therefore, MRMC studies involving human readers and AI assistance are not applicable.

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

• N/A. This device does not involve an algorithm or AI.

6. The type of ground truth used:

• For Bench Testing: Laboratory measurements, chemical analysis, physical property testing (e.g., dissolution, phase purity), and comparison to established standards (e.g., ASTM F1185).
• For Animal Testing: Histological analysis, imaging (if performed), and observation of bone formation and resorption in animal models.
• Overall: Comparison to the known performance and characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

• N/A. This refers to a medical device's performance, not an AI model's training data.

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

• N/A. This refers to an AI model's training data.

Conclusion based on the document:

The provided FDA 510(k) document is for a conventional Class II medical device (bone void filler) and asserts substantial equivalence to a predicate device. The "acceptance criteria" are based on meeting established material and biological safety standards (like ASTM F1185) and demonstrating similar performance to previously cleared devices through non-clinical (bench and animal) testing. The document does not describe the kind of detailed study data (e.g., clinical trials, AI performance metrics, reader study results, or specific ground truth establishment methodologies) that would be expected for a novel AI/software medical device.

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Actifuse™ Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow can be injected into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during process.

Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse 11d Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system. i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Actifuse™ Flow is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure inherent of the source material for the mineral phase of Actifuse™ Flow is similar to human cancellous bone.

The medical device described in the provided text is Actifuse™ Flow, a resorbable calcium salt bone void filler. The submission is a 510(k) premarket notification for modifications to the product line, specifically applicator syringe design changes.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for any of the tests. It broadly mentions "All test results meet the acceptance criteria" and "All testing was performed on the configuration of the devices presented in this premarket notification." This suggests that the testing was conducted on a sufficient number of units to support the conclusions, but the exact count is not given.

The data provenance is pre-market notification testing conducted by Baxter Healthcare Corporation. The location of the testing is not explicitly stated, but Baxter Healthcare Corporation is based in Deerfield, Illinois, USA. The testing appears to be prospective in the sense that it was specifically performed for this 510(k) submission to demonstrate substantial equivalence of the modified device.

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

There is no mention of experts or the establishment of "ground truth" using human experts for this specific submission. This is a non-clinical submission focused on material and design changes to an existing device, not a clinical study involving diagnosis or interpretation where expert consensus on "ground truth" (e.g., disease presence) would be relevant. The "ground truth" for this submission are the established specifications, chemical properties, and performance characteristics of the predicate device, against which the modified device is compared.

4. Adjudication Method for the Test Set

As this is a non-clinical submission, there is no adjudication method described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or other subjective data, to resolve discrepancies among readers/experts. These are not applicable to the chemical, physical, and sterility tests described.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or imaging devices where human readers' performance with and without AI assistance is compared. This submission pertains to a physical medical device (bone void filler) with modifications to its applicator syringe, not an AI or imaging diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This question typically applies to AI algorithms. The device described is a physical medical product, not an algorithm. The "performance" assessment here relates to chemical, physical, and biological properties of the device itself, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" used for this submission is based on established specifications, validated test methods, and existing regulatory clearances for the predicate device and the materials used. Specifically:

• Chemical/Structural Integrity: Ground truth is the defined chemical and structural properties of the predicate Actifuse™ Flow and its components.
• Biocompatibility: Ground truth is established biocompatibility standards (e.g., ISO-10993-1) and the successful prior clearance of the materials in other Baxter devices.
• Sterility: Ground truth is a 10^-6 Sterility Assurance Level (SAL) as established by international standards (ANSI/AAMI/ISO 11137-2).
• Shelf Life: Ground truth is the stability of a product over time, which is confirmed by specific aging tests.

Essentially, the ground truth is the established and acceptable performance of the predicate device and known standards, against which the modified device is compared.

8. Sample Size for the Training Set

There is no mention of a "training set" in this submission. Training sets are relevant for machine learning algorithms. This is a traditional medical device submission based on a direct comparison to a predicate device and engineering/material testing, not machine learning.

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

As there is no training set, this question is not applicable.

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NovoGro Putty is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovoGro Putty provides a bone void filler that resorbs and is replaced by bone during the healing process.

NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical beads that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical beads are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.

This document is a 510(k) premarket notification for a medical device called NovoGro, a resorbable calcium salt bone void filler device. It is not an AI/ML device, therefore, the information requested in the prompt related to acceptance criteria for an AI/ML device and its validation study (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

However, based on the document, I can extract information about the device's performance criteria and the study that supported its substantial equivalence to a predicate device.

Here's a summary of the requested information, adjusted for a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are not framed in terms of performance metrics like sensitivity or specificity. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device through various tests. The performance of the subject device (NovoGro) was deemed equivalent to the predicate (Actifuse ABX).

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

• Test Set (Animal Study): Not explicitly stated how many animals were in the "rabbit distal femoral condyle critical-sized defect model." The document mentions "baseline (time 0) animals" and "empty (unfilled) defects (negative control) evaluated at 6 weeks and 12 weeks," implying multiple animals within each group and time point, but the exact number isn't provided.
• Data Provenance: The animal study was conducted as pre-clinical testing, but the country of origin is not specified. It is a prospective study designed to compare the subject device against the predicate.

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

• Ground Truth Establishment: For the animal study, the "ground truth" or evaluative endpoints were based on objective scientific analyses.
  • Evaluators: The document mentions "high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis." Histology sections were also "graded according to AAMI/ANSI/ISO 10993-6 (Annex E)."
  • Number and Qualifications of Experts: Not specified. It can be inferred that these evaluations were performed by qualified personnel (e.g., veterinary radiologists, histopathologists, scientists trained in histomorphometry), but the specific number or their credentials are not detailed in this document.

4. Adjudication Method for the Test Set

• Given the objective nature of the evaluations (radiography, micro-CT, histology, histomorphometry, and grading against a standard), a formal "adjudication method" in the sense of expert consensus for subjective findings is less relevant here. The analyses rely on scientific methods and specified standards (e.g., AAMI/ANSI/ISO 10993-6). Any discrepancies would likely be resolved through re-evaluation or adherence to established protocols. The document does not describe a specific adjudication method.

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/ML device meant to assist human readers. The study performed was a comparative animal study of the device itself.

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

• Not applicable. This refers to AI/ML algorithms. The device is a physical bone void filler.

7. The type of ground truth used

• For the animal study: The ground truth was established through a combination of radiographic imaging, micro-CT imaging, undecalcified histologic evaluation, and histomorphometric analysis. These are objective scientific measurements and observations of tissue response and bone formation in an in-vivo model. Histology sections were also graded against a standard (AAMI/ANSI/ISO 10993-6 Annex E).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this type of device would refer to its development and refinement through pre-clinical testing, but not in the context of a "training set" for AI.

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

• Not applicable, as there is no AI/ML training set for this device.

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NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone.

The provided text is a 510(k) summary for the medical device NanoBone® SBX Putty. It details the device's characteristics, intended use, and equivalence to predicate devices, and includes a section on performance data.

However, the provided text does not contain the information requested to answer the specific questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop study for medical imaging. The document describes a traditional medical device (bone void filler) and its testing, which involves:

• Bench testing: Chemical/elemental analysis, phase purity/XRD, dissolution testing, sterilization validation, pyrogenicity testing.
• Biocompatibility assessment/testing.
• Animal testing: Using a critical-sized femoral condyle defect model in New Zealand white rabbits, with analysis via histology, histomorphometry, micro CT, and image analysis for new bone formation and product resorption.

This type of testing is characteristic of a substance or implantable material, not an AI-powered diagnostic device or a system that requires human-in-the-loop performance evaluation through MRMC studies. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/human performance improvement, ground truth establishment for a test or training set, or expert qualifications and adjudication methods as these concepts are not applicable to the described device and its testing in the provided document.

To answer your question, information about AI-specific acceptance criteria, test set sizes, expert ground truth establishment, MRMC studies, and training set details would need to be present, which it is not in this document.

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Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Actifuse™ Flow is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure inherent of the source material for the mineral phase of Actifuse is similar to human cancellous bone. Actifuse Flow is available as a hydrated putty.

This is a submission for a medical device (Actifuse™ Flow Bone Graft Substitute) and not an AI/ML device, so many of the requested fields (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable. The provided document is a 510(k) Premarket Notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than performance metrics of an AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a medical device (bone graft substitute), not an AI/ML device. The testing referenced is bench testing on the physical properties of the material, not a clinical study on human data in the context of AI.

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

Not applicable (see point 2).

4. Adjudication method for the test set

Not applicable (see point 2).

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 not an AI.

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

Not applicable. This device is not an AI.

7. The type of ground truth used

For bench testing, the "ground truth" would be established by the physical and chemical properties of the material itself and its performance against established engineering or biological standards for bone graft substitutes. The document states "Bench testing has shown Actifuse™ Flow to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers" and that it was "confirmed...safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." This suggests compliance with pre-defined criteria rather than an expert consensus or pathology review of a specific clinical outcome dataset.

8. The sample size for the training set

Not applicable. This device is not an AI.

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

Not applicable. This device is not an AI.

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PROGENIX™ DBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX™ DBM Putty is a single use product intended for use as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

Acceptance Criteria and Device Performance for Medtronic Sofamor Danek PROGENIX™ DBM Putty

This document describes the acceptance criteria and the study used to demonstrate the performance of the PROGENIX™ DBM Putty, as outlined in the provided 510(k) summary (K072265).

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the expanded indication of PROGENIX™ DBM Putty (use as a bone graft extender in spinal fusion procedures) were based on demonstrating its effectiveness in producing spinal fusion.

2. Study Design and Data Provenance

The study that demonstrated the expanded indication for PROGENIX™ DBM Putty was a rabbit study.

• Sample Size: Not explicitly stated in the provided text, but the study was conducted on a sufficient number of rabbits to "suggest that PROGENIX™ DBM Putty is effective."
• Data Provenance: The study was conducted in a pre-clinical animal model (rabbit). No country of origin is specified for the study location. The study is prospective as it evaluates the device's performance in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used or their qualifications for establishing the ground truth of the rabbit study. However, the assessment of spinal fusion (radiographic and manual palpation) would typically involve trained veterinary radiologists and/or surgeons.

4. Adjudication Method

The adjudication method used for the rabbit study is not explicitly stated. However, given the nature of radiographic assessment and manual palpation, it is likely that the evaluation was performed by one or more trained individuals.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is a pre-clinical animal study for a bone graft substitute, not a diagnostic imaging device.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a bone graft substitute, not an algorithm or software. Its performance is assessed through biological outcomes in vivo.

7. Type of Ground Truth Used

The ground truth used in the rabbit study was based on direct observation and objective assessments of fusion in an animal model:

• Radiographic criteria: Imaging evidence of spinal fusion.
• Manual palpation criteria: Physical assessment of spinal fusion.

8. Sample Size for the Training Set

Not applicable. This is a biological device, not an AI/ML algorithm that requires a training set. The "study" refers to the pre-clinical validation for the expanded indication.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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