(186 days)
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."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalent dissolution characteristics to predicate device | Demonstrated to have equivalent dissolution characteristics to the predicate device. |
| Equivalent mechanical characteristics to predicate device | Demonstrated to have equivalent mechanical characteristics to the predicate device. |
| Equivalent mass to volume ratio characteristics to predicate device | Demonstrated to have equivalent mass to volume ratio characteristics to the predicate device. |
| Non-pyrogenic | Indicated that the product is nonpyrogenic. |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.