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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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CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.

CuriOs™ is a micro-structured calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a betatricalcium phosphate and hydroxyapatite. The product is provided sterile.

The provided document, a 510(k) Premarket Notification for the CuriOs™ device, does not describe an acceptance criteria table or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

This document pertains to a medical device (bone void filler), not a software product. Therefore, the questions related to AI-specific elements (e.g., test set sample size, ground truth experts, MRMC studies, standalone algorithm performance, training set) are not applicable to the information contained in this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Physico-chemical properties: Similar composition (beta-tricalcium phosphate and hydroxyapatite).
• Pre-clinical testing: Confirmation of similar resorption profile, safety, and biocompatibility.
• Intended Use: The CuriOs™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, and as an autologous bone graft extender.

The "Performance data" section explicitly states: "The CuriOs™ is tested to conform to applicable requirements of the recognized standards. The devices to which the CuriOs™ claims substantial equivalence are Vitoss™ Scaffold (OrthoVita) and OsSatura™ BCP (IsoTis)." This indicates that performance was assessed against established standards relevant to bone void fillers and by comparing it to already approved devices.

Summary based on the provided text:

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

• Acceptance Criteria: Not explicitly detailed as a table in the provided text. The criteria are implied by "applicable requirements of the recognized standards" and demonstration of similar composition, resorption profile, safety, and biocompatibility compared to predicate devices.
• Reported Device Performance: The document states that CuriOs™ "confirmed the similar composition, resorption profile, safety, biocompatibility and effectiveness" when compared to predicate devices (Vitoss™ Scaffold and OsSatura™ BCP) through physico-chemical and pre-clinical testing.

The following points are NOT APPLICABLE to this traditional medical device submission:

2. Sample size used for the test set and the data provenance: N/A (This is not an AI/SaMD study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (This is not an AI/SaMD study).
4. Adjudication method for the test set: N/A (This is not an AI/SaMD study).
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: N/A (This is not an AI/SaMD study).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an AI/SaMD study).
7. The type of ground truth used: N/A (This is not an AI/SaMD study). For a traditional medical device like this, "ground truth" would be established through established laboratory testing protocols, animal studies, or clinical data (if a clinical study were performed, though none is detailed here beyond "pre-clinical testing").
8. The sample size for the training set: N/A (This is not an AI/SaMD study).
9. How the ground truth for the training set was established: N/A (This is not an AI/SaMD study).

In conclusion, this 510(k) submission demonstrates substantial equivalence for a bone void filler by comparing its material properties, safety, and performance to already legally marketed devices, rather than through an AI/software performance study.

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