(90 days)
ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty Products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are 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® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products come in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ALLOMATRIX® Putty products, organized according to your requested information.
It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a specific benchmark. Therefore, some of your requested points, particularly those related to quantitative performance metrics for AI/human reader studies, are not directly applicable or available in this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria / Benchmark | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is substantially equivalent to predicate devices. | ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products were found to be substantially equivalent to the predicate devices. |
| Osteoinductivity (DBM component) | DBM component demonstrates osteoinductive potential. | Bioassay measures proliferation of Saos human osteosarcoma cells in presence of DBM (osteoinductivity index). Results from bioassay correlated with athymic rat muscle implantation (correlation coefficient 0.850, p0.20 index showed 92% healing vs. 33% for ≤0.20 index. Each lot of DBM is evaluated with this cell-based bioassay to ensure osteoinductive potential. |
| Viral Inactivation Potential (DBM) | Processing methods provide significant viral inactivation. | DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses. |
| Viral Inactivation Potential (CBM) | Processing methods provide some viral inactivation, with low risk. | CBM processing methods were determined to provide some viral inactivation potential for a wide range of viruses. The risk of disease transmission remains low due to multiple safeguards (donor selection, laboratory testing, material processing). |
| Clinical Performance (Radiographic) | No significant differences in radiographic outcomes compared to predicate devices. | There were no significant differences in the radiographic outcomes of the ALLOMATRIX® Putty Products and the predicate devices. |
| Clinical Performance (Adverse Events) | No significant differences in adverse event profiles compared to predicate devices. | There were no significant differences in the adverse event profiles of the ALLOMATRIX® Putty Products and the predicate devices. |
| Animal Model Performance | DBM putty formulations with CBM show acceptable performance (radiographic and histological). | Performance of DBM putty formulations including varying amounts of CBM were evaluated in a canine model by radiographic and histological methods. (Specific quantitative results not provided in this summary, but the implication is that the performance was acceptable for equivalence). |
Study Details (Where Applicable and Provided)
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Sample size used for the test set and the data provenance:
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Osteoinductivity Bioassay:
- Test Set: 101 donor lots for the correlation study with athymic rat model.
- Provenance: Not explicitly stated, but implied to be human DBM samples. The correlation study references Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive 2 grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300. for the rat model, and Wilkins, R.M. (1999) Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell l Culture, Advances in Tissue Banking. 3:113-124 for the clinical correlation, suggesting diverse data sources.
- Retrospective/Prospective: The correlation studies appear to be retrospective analyses of DBM lots. The statement "Each lot of DBM...is evaluated in vitro" implies prospective testing for quality control of the DBM component used in the putties.
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Clinical Performance (Radiographic/Adverse Events):
- Test Set: Not explicitly stated how many patients or cases were evaluated for the comparison to predicate devices, but described as "a comparison of radiographic outcomes and the adverse event profiles."
- Provenance: Not specified (e.g., country of origin, retrospective/prospective). This comparison would typically be based on existing clinical data or published literature related to the predicate devices and the new device's preliminary clinical observations.
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Canine Model:
- Test Set: Not specified how many canines were used.
- Provenance: Not specified (source of animals, experimental design).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
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Osteoinductivity Bioassay: Ground truth for osteoinductivity relies on the definition provided: "The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes." This implies histological evaluation, which would typically be performed by trained histologists or pathologists. The number is not specified.
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Clinical Performance (Radiographic): For "radiographic outcomes," ground truth would typically be established by radiologists or orthopedic surgeons. The number and qualifications are not specified.
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Canine Model: Histological evaluation would be performed by experts (e.g., veterinary pathologists/histologists). Number and qualifications are not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified for any of the studies mentioned.
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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:
- No MRMC comparative effectiveness study was done. This product is a bone void filler, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Osteoinductivity: Primarily pathology/histology (for the athymic rat model, defined by the presence of new bone, cartilage, or chondrocytes) and in vitro bioassay results correlated with clinical healing.
- Viral Inactivation: Laboratory testing (measuring viral reduction factors for model viruses).
- Clinical Performance: Radiographic outcomes (interpreted by clinicians) and adverse event profiles (clinical outcomes data).
- Canine Model: Radiography and histology (pathology).
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The sample size for the training set:
- Osteoinductivity Bioassay: No specific "training set" in the machine learning sense is described. The bioassay was correlated with clinical results from Wilkins (1999) and Lindholm & Urist (1980), which would represent datasets used to establish the validity and predictive power of the bioassay. The size of these historical datasets is not specified in detail beyond the 101 donor lots used for the correlation study.
- Other studies: Not applicable as these are not machine learning models.
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How the ground truth for the training set was established:
- Osteoinductivity Bioassay: The ground truth for the bioassay's predictive capability was established through:
- Pathology/Histology: For the athymic rat model, where bone formation was histologically confirmed and defined.
- Clinical Outcomes Data: For the clinical correlation mentioned by Wilkins (1999), where radiographic healing for DBM alone was assessed and linked to the bioassay index. This would involve assessment by qualified medical professionals (e.g., radiologists, orthopedic surgeons) interpreting patient radiographs.
- Osteoinductivity Bioassay: The ground truth for the bioassay's predictive capability was established through:
§ 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.