(45 days)
OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.
OSMOSYS is a synthetic bone substitute composed of a mixture of hydroxyapatic (HA) and tricalcium phosphate (TCP). The resulting product is a biphasic macro-porous bio-ceramic designed to fill bony void gaps of the skeletal system (i.e., the extremities, spine and polvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. Analysis by pycnometry reveals the presence of pores representing on average 70% of the volume of the material. The pores are between 300um and 500μm, correlating well with the values from optic microscopy. OSMOSYS is available in the form of irregular granules (2-3 mm) and sticks (5x5x20 mm). OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003.
The provided text is a 510(k) summary for the OSMOSYS Calcium Phosphate Ceramic Bone Filler, which describes a medical device, its intended use, and its equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical trials or algorithm performance metrics.
The document discusses the device's composition, porosity, pore size, and resorption, stating that it is "similar to the predicate device in terms of composition, porosity, pore size, and resorption." It also mentions that "OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003," which are material standards and not performance criteria for a diagnostic algorithm.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This is a regulatory submission for a physical medical device (bone void filler), not a diagnostic or AI-driven device, so the criteria and study types requested (e.g., related to AI, diagnostic accuracy, human reader performance) are not applicable to the content provided.
§ 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.