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AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis) and may be used in combination with autogenous bone. These osseous defects may be surgically created of of traumatic injury to the bone and are not instrinsic to the stability of the bony structure. AttraX Putty resorbs and is replaced with bone during the healing process.

NuVasive AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules. Pressure applied by user manipulation allows the AttraX Putty to be molded into specific shapes, mixed with autograft, or contoured into a bone defect, as desired by the clinician. The subject device is identical to the primary predicate device Progentix AttraX Putty (K151584). No changes to the design, materials, or methods of manufacture have been made for this submission.

The NuVasive AttraX Putty is a resorbable calcium salt bone void filler device. The provided text outlines the 510(k) submission for this device, which aims to expand its indications for use as a bone graft replacement. The primary study presented to support this expansion is a clinical trial evaluating the device's performance in instrumented thoracolumbar posterolateral fusion.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, the study's objective provides the implicit acceptance criterion: non-inferiority to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document states "a randomized controlled trial" and "a patient and observer blinded, multicenter, prospective, randomized controlled trial." However, the specific number of patients (sample size) enrolled in this clinical trial is not provided in the given text.
• Data Provenance: The study was a "multicenter, prospective, randomized controlled trial." The country of origin is not specified, but it's reasonable to assume it was conducted with data that would be relevant for FDA submission (likely in the US or with internationally recognized standards).

3. Number of Experts and Qualifications for Ground Truth

The text does not provide information regarding:

• The number of experts used to establish ground truth for the test set.
• The qualifications of those experts.
• How ground truth (e.g., successful fusion) was determined (e.g., by independent radiologists, surgeons assessing outcome).

4. Adjudication Method for the Test Set

The text does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set. It mentions the study was "patient and observer blinded," which relates to the methodology but not specifically to the adjudication of outcomes by experts.

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

An MRMC study was not conducted/applicable in this context. This device is a bone void filler, and its effectiveness is determined by clinical outcomes (e.g., successful fusion, absence of complications) rather than the interpretation of medical images by multiple readers. The study was a direct comparison between the device and autologous bone graft for a clinical outcome.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study was not conducted/applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its clinical efficacy and safety in human subjects, not as an "algorithm only" system.

7. Type of Ground Truth Used

The ground truth used was clinical outcome data from human subjects, specifically focusing on the non-inferiority of the device compared to autologous bone graft in instrumented posterolateral spinal fusion. While not explicitly detailed, ground truth would likely involve assessments of fusion success (e.g., imaging like CT scans reviewed by radiologists, clinical stability assessments by surgeons, patient-reported outcomes). The text refers to "Level I clinical evidence," indicating robust clinical data.

8. Sample Size for the Training Set

This question is not applicable as the device is a medical implant, not an AI algorithm requiring a "training set" in the machine learning sense. The data used for evaluation comes from a clinical trial, which serves as the "test set" for regulatory clearance.

9. How Ground Truth for Training Set Was Established

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

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AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (beta-TCP > 90%) and hydroxyapatite (HA

The provided text is a 510(k) summary for the medical device AttraX Putty. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific acceptance criteria in the format requested.

Instead, it relies on non-clinical testing and an animal study to demonstrate substantial equivalence to legally marketed predicate devices. The document aims to show that AttraX Putty is as safe and effective as existing devices, rather than meeting predefined numerical performance targets.

Here's a breakdown of what can be extracted and what information is missing based on your request:

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

This information is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and overall performance in non-clinical and animal studies, rather than against specific quantitative acceptance criteria for device performance.

While the document states, "The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject AttraX Putty and the predicate AttraX Granules," and "The performance of the subject AttraX Putty was compared to that of the predicate AttraX Granules in a posterolateral spine fusion animal model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate," these are qualitative statements about equivalence, not numerical acceptance criteria or performance metrics.

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

• Sample size for the test set: The specific sample size for the "posterolateral spine fusion animal model" is not explicitly stated.
• Data provenance: The country of origin and whether the study was retrospective or prospective are not specified. The submitter, Progentix Orthobiology B.V., is located in The Netherlands, which might suggest the study was conducted there or overseen by them, but this is not definitively stated for the animal model.

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 present. The study referenced is an "animal model" and doesn't mention human experts establishing ground truth for a test set in the way an AI diagnostic study would.

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

This information is not applicable and not present. Adjudication methods are typically used in studies involving human readers or expert panels to resolve discrepancies in ground truth establishment for diagnostic performance evaluation, which is not the focus 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:

This information is not present and not applicable. The document describes a medical device (a bone void filler), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be part of this 510(k) submission.

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

This information is not present and not applicable. This is a medical device, not an algorithm.

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

For the "posterolateral spine fusion animal model," the "ground truth" would likely be based on:

• Histopathology/Microscopic analysis: To assess new bone formation, resorption of the material, and tissue integration.
• Imaging (e.g., X-ray, CT): To evaluate bone fusion and material degradation over time.
• Biomechanical testing: To assess the strength of the fusion.

However, the specific methods are not detailed beyond stating "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate."

8. The sample size for the training set:

There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical and animal studies serve as verification and validation activities for the device itself.

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

Not applicable, as there is no training set mentioned for an AI/machine learning context.

Summary of what the document DOES provide regarding studies:

The document mentions several types of studies and testing without providing explicit "acceptance criteria" or detailed performance metrics as requested for an AI diagnostic device.

• Non-clinical testing:
  • Biocompatibility testing: Performed using methods described in ISO 10093-1, ISO 10093-3, ISO 10093-5, ISO 10093-6, ISO 10093-10, and ISO 10093-11. (Results: Not detailed, but implied to be acceptable for substantial equivalence).
  • Material characterization:
    • Chemical composition and crystallinity by x-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), and organic volatile impurity analysis (OVI).
    • Trace elemental analysis by inductively coupled plasma/mass spectroscopy (ICP/MS).
    • Surface microstructure and mineralization by scanning electron microscopy (SEM).
    • Physical properties including porosity by mercury intrusion porosimetry, dissolution, and water content.
    • Reported performance: "The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject AttraX Putty and the predicate AttraX Granules."
• Animal study:
  • Study type: "posterolateral spine fusion animal model."
  • Purpose: Compared the performance of AttraX Putty to the predicate AttraX Granules.
  • Reported performance: "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate."

In conclusion, this document is a regulatory submission for a traditional medical device demonstrating substantial equivalence, not an AI performance study with explicit acceptance criteria and detailed study parameters for an algorithm.

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