(113 days)
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.
This 510(k) summary (K080065) is for a medical device called "OSferion," which is a bone void filler. This submission does not refer to a study evaluating a device with AI/ML technology. Instead, it is a premarket notification for a traditional medical device, comparing it to predicate devices already on the market. Therefore, many of the requested categories related to AI/ML device studies are not applicable.
Here's the breakdown of the information that can be extracted from the provided text, and where the information is not available due to the nature of the device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a conventional medical device (bone void filler) based on substantial equivalence, there are no specific quantitative "acceptance criteria" for an AI model's performance (like sensitivity, specificity, AUC) outlined in this document as there would be for an AI/ML diagnostic or prognostic device. The acceptance is based on demonstrating substantial equivalence to predicate devices, focusing on materials, indications for use, and mechanism of action.
| Acceptance Criteria (from a traditional device perspective) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Indications for Use: To be gently packed or placed into bony voids or gaps of the skeletal system (extremities, spine, pelvis) that are not intrinsic to structures stability. Scaffold resorbs and is replaced by bone. | OSferion's Indications for Use are "basically identical" to predicate devices. |
| Material Composition: B-tricalcium phosphate (B-TCP). | OSferion is composed of B-tricalcium phosphate (B-TCP). |
| Biological Function: Bone replacement material, allowing replacement by autogenous bone after implantation. | Has properties that allow it to be replaced by autogenous bone after implantation. |
| Safety and Efficacy: Supported by clinical literature. | The clinical literature provided in this submission supports the safety and efficacy of OSferion. |
| Technological Characteristics: Similar to predicate devices. | OSferion is "similar in specifications of the material" to predicate devices. |
| No Significant Changes Affecting Safety/Effectiveness: No changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to predicate. | Concluded that the device "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. Since it's not an AI/ML device, there isn't a "test set" in the context of algorithm evaluation. The submission refers to "clinical literatures" to support safety and efficacy, but details about these studies (sample size, data provenance) are not present in this abstract.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable/not provided. As there is no AI/ML algorithm being evaluated, there is no "test set" requiring ground truth established by experts in this context. The evaluation is based on material properties, intended use, and comparison to legally marketed predicate devices.
4. Adjudication Method for the Test Set
This is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This submission is for a physical medical device (bone void filler), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance would not have been performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. There is no algorithm being evaluated in this submission.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the predicate devices (Synthes chronoSTM and Vitoss® Scaffold) based on their regulatory approvals and clinical use. The "truth" for OSferion's acceptability is its substantial equivalence to these devices, which implies similar clinical performance. The submission states that "The clinical literatures provided in this submission supports the safety and efficacy of OSferion," indicating that past clinical data on similar materials/devices form the basis of the "truth."
8. The Sample Size for the Training Set
This is not applicable. There is no AI model, and thus no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 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.