(240 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 β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.
The provided text is a 510(k) summary for a medical device called OSferion, a bone void filler. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
However, the document does not contain information related to a study that establishes acceptance criteria for performance, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) comparative effectiveness studies.
The document concludes that "When compared to the predicate device, this particular device "OSferion" does not incorporate changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a direct performance study with predefined metrics.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:
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A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The document establishes substantial equivalence to predicate devices (chronOS and Vitoss) rather than reporting specific performance metrics against pre-defined acceptance criteria for OSferion itself. The "performance" is considered equivalent if the device shares the same intended use, materials (with some variation in porosity), and operates safely and effectively, as confirmed by regulatory review.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of specifications and clinical literature, not on a new clinical trial with a "test set" in the context of device performance metrics.
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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)
- Not applicable / Not provided. Ground truth establishment, in this context, is not mentioned as part of the 510(k) submission process described. The "ground truth" for regulatory clearance is the accepted safety and effectiveness of the predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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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 / Not provided. This device is a bone void filler, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is not an algorithm-based device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided in the context of performance testing for this specific device. The "ground truth" for the 510(k) process is the established safety and effectiveness of the legally marketed predicate devices. The submission relied on "clinical literature provided in this submission supports the safety and efficacy of OSferion," which would presumably draw upon outcomes data or clinical observations related to similar materials.
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The sample size for the training set
- Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- Not applicable / Not provided.
Summary of what the document implies about meeting acceptance criteria:
The acceptance criteria for OSferion, as presented in this 510(k) summary, are met by demonstrating substantial equivalence to existing predicate devices (chronOS and Vitoss). This means the device is deemed safe and effective if it shares the same:
- Intended Use: Filling bony voids or gaps of the skeletal system that are not intrinsic to stability.
- Patient Population: Individuals with bone voids or gaps caused by surgery or trauma.
- Anatomical Location: Extremities, spine, and pelvis.
- Labeling: Similar intended use, contraindications, warnings, precautions, and adverse events.
- Basic Material Composition: β-Tricalcium phosphate.
- Biocompatibility: Established.
- Mechanical Strength Characteristics: Does not impart mechanical strength to the surgical site.
- Sterility: Sterile, single use.
The document highlights that OSferion is "basically identical to the predicate devices in the indication for use, and is similar in specifications except for the porosity of the material." The "clinical literature provided in this submission supports the safety and efficacy of OSferion" as a basis for meeting these criteria.
§ 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.