(717 days)
ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.
ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing sclution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
The provided document is a 510(k) summary for ALLOMATRIX® Putty, a bone void filler. It describes the device, its intended use, and substantial equivalence information based on materials data and testing results. However, it does not contain a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML-based medical devices or comparative clinical trials.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
- Osteoinductivity Potential: In-vitro bioassays and in-vivo rat muscle pouch studies to show the DBM component is osteoinductive.
- Viral Inactivation Validation: Testing of the processing method to ensure viral inactivation.
- Product Performance Testing: A comparison of radiographic outcomes and adverse event profiles to a predicate device, and evaluation in a canine model.
Therefore, many of the requested categories for a study demonstrating acceptance criteria cannot be filled from this document as it's not a performance study in that context.
Here's an attempt to extract relevant information and note what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary, specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) are not defined in the way they would be for a diagnostic AI device. The "performance" is described qualitatively in relation to the predicate device and fundamental material properties.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrates safety and effectiveness comparable to a predicate device. | "ALLOMATRIX® Putty was found to be substantially equivalent to the predicate device. The safety and effectiveness of ALLOMATRIX® Putty is adequately supported by the substantial equivalence information, materials data, and testing results provided..." "There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device." |
| Osteoinductivity | DBM component must exhibit osteoinductive potential. | In-vitro bioassay (Saos human osteosarcoma cells) showed a correlation coefficient of 0.850 (p0.20 osteoinductivity index showed 92% healing vs. 33% for ≤0.20. |
| ALLOMATRIX® Putty was found to be osteoinductive in vivo in the rat muscle pouch model. Each lot is assayed. | ||
| Viral Inactivation | Processing method must demonstrate suitable viral inactivation potential for a panel of human viruses. | Testing demonstrated "suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses." |
| Clinical Performance | Radiographic outcomes and adverse event profiles comparable to predicate device. | "There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device." |
| Biocompatibility/Safety | Compatible with biological systems (implied by material composition and predicate comparison). | (Implicit, no specific test results on biocompatibility explicitly stated beyond adverse events and material data.) |
| Handler/Placement | Able to be gently packed into bony voids. | "After the powder is hydrated...the resultant putty can then be handled and placed in the appropriate bone voids." (Stated as a property, not a measured performance criterion). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Osteoinductivity in-vitro/in-vivo correlation: "99 of 101 donor lots" were accurately predicted for in-vivo osteoinductivity. This implies a sample size of 101 DBM donor lots. Data provenance not specified (likely US, given the submission location).
- Clinical results (DBM healing): Not explicitly stated, but "clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing" suggests a patient cohort. Sample size for these clinical results is not provided in this document. Data provenance is not specified.
- Product Performance Testing (Clinical): Comparison "compared to the predicate device" implies a retrospective analysis of clinical outcomes from existing data or literature. No sample size, country of origin, or study design (retrospective/prospective) is provided.
- Product Performance Testing (Canine Model): A canine model was used. Specific sample size (number of canines or defects) is not provided.
3. 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 in the context of this 510(k) for a bone void filler. The "ground truth" here relates to biological activity (osteoinductivity) and clinical outcomes, not expert interpretation of diagnostic images.
- Radiographic evaluations would likely be performed by physicians, but no details are provided about the number or qualifications of clinicians assessing the "radiographic outcomes" for either the predicate device comparison or the DBM clinical healing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically relevant for human review of independent reads/interpretations, which is not described for this device's performance testing.
- Clinical outcomes and radiographic assessments would involve medical review, but no specific adjudication method is mentioned.
5. 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
- No. This is not an AI/ML device, and no MRMC study, or any study involving human reader improvement with AI assistance, was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's inherent biological and physical properties. The osteoinductivity and viral inactivation tests could be considered "standalone" in that they assess the product itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Osteoinductivity:
- In-vitro: Bioassay measurements (proliferation of Saos human osteosarcoma cells, osteoinductivity index).
- In-vivo (animal model): Histological analysis (presence of new bone, cartilage, and/or chondrocytes in explants – explicitly defined).
- Clinical (DBM): Radiographic evaluation of healing.
- Viral Inactivation: Assays demonstrating reduction of viral titers after processing.
- Clinical Performance (comparison to predicate): Radiographic outcomes and adverse event profiles.
- Canine model: Radiographic and histological methods.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, this question doesn't apply.
§ 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.