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The paste made with the ProFusion® Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

ProFusion® paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.

ProFusion® Bone Graft Substitute Kits consist of pre-measured medical grade calcium sulfate powder and pre-measured mixing solution, and the tools necessary to mix the components into a paste. The device is provided sterile for single use only. When its components are mixed according to the instructions, the ProFusion Kits produce biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The provided text is a 510(k) Summary for the ProFusion® Bone Graft Substitute Kits. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a standalone study with performance metrics in the way a clinical trial or AI algorithm validation would.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from this document. The document states that performance data was submitted, but it does not detail the acceptance criteria or the specific numerical results of that performance data.

Here's a breakdown based on the information available and not available in the provided text:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this document)

The document states: "Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices." This is the core claim for a 510(k) submission. It does not provide specific acceptance criteria (e.g., "resorption rate must be X to Y days") and then report on the device's performance against those criteria. Instead, it asserts equivalence to predicate devices, implying that the predicate devices' established performance is the de facto "acceptance criteria."

Detailed Study Information (Not applicable for this 510(k) Submission type)

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

   • Not provided. The document states "Testing demonstrated...", but does not specify the sample size of any test set (e.g., number of implants, animal studies, etc.) or the provenance of the data.

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

   • Not applicable/Not provided. This type of information would be relevant for studies involving human interpretation (e.g., radiology images). This document describes a physical medical device (bone graft substitute), not an AI diagnostic tool or a device requiring expert interpretation for ground truth establishment in a test set.

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

   • Not applicable/Not provided. See the explanation for point 2.

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:

   • Not applicable. This device is a bone graft substitute, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not explicitly stated in terms of a formal "ground truth" process. For a bone graft substitute, "ground truth" for performance would likely involve histological analysis of bone ingrowth, resorption rates, biocompatibility assessments, and mechanical integrity tests in in vitro or in vivo models, typically compared against predicate devices or known biological responses. The document only states "Testing demonstrated that the performance... are substantially equivalent."

7. The sample size for the training set:

   • Not applicable/Not provided. This would be relevant for machine learning models, which is not the case here.

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

   • Not applicable/Not provided. See the explanation for point 7.

Summary of what is available:

• Device Type: Resorbable calcium salt bone void filler device.
• Purpose of Submission: 510(k) premarket notification to establish substantial equivalence to predicate devices.
• Key Performance Claim: Substantial equivalence to predicate devices in chemical composition, indications of use, performances, and design features.
• Resorption Time: Approximately 30-60 days (when used according to labeling).
• Sterility: Provided sterile for single use only.
• Biocompatibility/Biodegradability: Stated to be biodegradable and biocompatible, allowing use at an infected site.

In conclusion, this 510(k) summary provides a regulatory overview and basic device description, but it is not a detailed scientific study report with explicit acceptance criteria, performance metrics, and methodological details like sample sizes or ground truth establishment that would be required for a clinical trial or AI validation study. The "acceptance criteria" here are implicitly tied to the performance and characteristics of the legally marketed predicate devices.

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The ProFusion™ implants are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bony cavities may be surgically created or the result of traumatic injury. The implant provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Because the implant is biodegradable and biocompatible, it may be used at an infected site.

ProFusion™ implants are made of medical grade caloium suffate and stearic acid (as processing aid). They are provided sterile for single use. The implants are non-pyrogenic, biodegradable, radiopaque and resorbed in approximately 30-60 days, when used according to labeling.

The provided text describes the 510(k) summary for the ProFusion™ Bone Graft Substitute. It does not present a study with acceptance criteria and device performance in the format of a table, nor does it detail a study involving human readers or AI assistance.

Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data related to material properties.

Here's an analysis based on the information provided, addressing the questions as much as possible, with recognition of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with numerical targets and corresponding device performance values as would be expected for a diagnostic or AI-driven device. Instead, it states that "Testing demonstrated that the ProFusion devices have equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device." and "Testing indicated that the product is nonpyrogenic."

Therefore, the acceptance criteria can be inferred as "equivalence to the predicate device (Wright Plaster of Paris Pellets / Osteoset® Pellets) in dissolution, mechanical properties, and mass to volume ratio," and "non-pyrogenic."

The reported device performance is simply a statement that these equivalencies and non-pyrogenicity were "demonstrated" or "indicated."

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

The document does not specify sample sizes for any tests. It also does not mention a "test set" in the context of clinical data or image analysis. The "testing" referred to is for material properties. Data provenance (country, retrospective/prospective) is thus not applicable or mentioned.

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

This information is not applicable to the type of device and study described. This device is a bone graft substitute, and its evaluation focuses on material properties, not diagnostic accuracy requiring expert interpretation of images or other clinical data for a "ground truth."

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance with or without AI assistance are irrelevant to this submission.

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

No, a standalone algorithm performance study was not done. This device is a physical bone graft substitute, not a software algorithm.

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

The concept of "ground truth" as typically defined for diagnostic device studies (e.g., expert consensus for diagnoses, pathology for disease presence, outcomes data for treatment efficacy) is not applicable here. The "truth" for the ProFusion™ device refers to its material properties and chemical composition being equivalent to the predicate device and its non-pyrogenicity. This would have been established through standard laboratory testing methods for material science.

8. The sample size for the training set

The document does not mention a training set. This device is not an AI/ML algorithm that requires training data.

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

This question is not applicable as there is no training set for this type of device.

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