(89 days)
AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is in licated for use in the treatment of surgically created osseous defects or oss :ous defects created from traumatic injury.
AlloCraft is intended for single patient use only.
AlloCraft, like all bone graft materials c >ntaining demineralized bone matrix, is a bone vold finer mallinary of paring structures. AlloCraft is packaged in two Separate Syringes, one contaming tresus pended in sterile saline. When mixed, the containing acchuiar dermal maxxture that can be molded or handled by the surgeon, or placed directly into the osse >us defect site.
The provided text is a 510(k) summary for the AlloCraft™ DBM device, seeking clearance as a medical device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in a human clinical setting with defined metrics like sensitivity, specificity, or accuracy.
The performance data mentioned in the document is limited to preclinical assessments:
Performance Data Section Analysis:
- Study Description: "LifeCell has assessed the osteoconductive and osteoinductive properties of AlloCraft in valid animal models. The Company also establishes the AlloCraft in valid anniala nivach lot of the DBM component of AlloCraft in ostcomadel. In all instances, /11loCraft functioned as intended and the bone formation observed was as expected."
- Acceptance Criteria & Device Performance: This section does not define specific, quantifiable acceptance criteria (e.g., "X% bone formation at Y weeks"). Instead, it broadly states that the device "functioned as intended" and "bone formation observed was as expected." This is a qualitative statement rather than a measurable metric.
- Sample Size (Test Set) and Data Provenance: The document states "valid animal models" and "each lot of the DBM component" but does not specify the number of animals or lots used in these studies. The data provenance is animal models, not human data.
- Experts and Ground Truth: The document does not mention the use of experts to establish a ground truth. Bone formation would likely be assessed histologically or radiographically in animal models, but the specific method, number of observers, or their qualifications are not provided.
- Adjudication Method: Not applicable, as there's no mention of expert review or consensus.
- MRMC Comparative Effectiveness Study: No MRMC study was conducted or mentioned. The performance data is solely on the device's material properties in animal models, not its comparative effectiveness with human readers.
- Standalone Performance: The described "performance data" is focused on the material properties and biological response of the device in animal models. It does not measure a "standalone" algorithmic performance as typically understood for AI/software devices.
- Type of Ground Truth: The ground truth used was observed bone formation in animal models, likely through methods like histological analysis.
- Training Set Sample Size: Not applicable, as this is not an AI/ML device that requires a training set.
- Training Set Ground Truth Establishment: Not applicable.
Summary Table (Based on available information from the document):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductive properties in valid animal models | Functioned as intended; bone formation observed as expected |
| Osteoinductive properties in valid animal models | Functioned as intended; bone formation observed as expected |
| Each lot of DBM component in osteomodel (a type of animal model) | Functioned as intended; bone formation observed as expected |
Additional Information Not Present in the Document:
- No specific quantifiable acceptance criteria (e.g., minimum percentage of bone formation, specific strength values).
- No human clinical study data.
- No detail on the methodology for assessing "bone formation as expected" (e.g., specific assays, histological grading scales).
- No information regarding blinding or independent review of animal study results.
- No information on the statistical significance or confidence intervals of the findings.
§ 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.