(20 days)
Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine.
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Synthetic Bone Putty." It outlines the FDA's determination of substantial equivalence to predicate devices and discusses regulatory requirements.
However, the document does not contain any information regarding:
- Acceptance criteria for device performance.
- A study proving the device meets specific acceptance criteria.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance" section mentions that the subject device's performance has been previously cleared and leverages prior studies for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterization/bench performance. It also states that "The device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This implies that performance data exists, but the details of the studies themselves (methodology, acceptance criteria, results) are not included in this FDA communication.
Therefore, I cannot provide a table of acceptance criteria and reported performance or details about the studies as requested, because that information is not present in the provided text.
§ 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.