(143 days)
Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.
MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use.
The provided text describes a medical device, MONTAGE-QS Settable, Resorbable Bone Putty, and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria and a study proving the device meets those criteria in the context of typical AI/software device evaluation.
Based on the provided information, here's an attempt to answer your request, focusing on the information that is present and noting where information is absent for an AI device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the performance evaluation is based on demonstrating equivalence to a predicate device through various tests. The "performance" for MONTAGE-QS is a qualitative assessment of its material properties and biological response compared to the predicate.
| Test Category | Specific Test | Acceptance Criteria (Implied/Compared) | Reported Device Performance (MONTAGE-QS) |
|---|---|---|---|
| Efficacy | Cranioplasty in rabbit critical-sized defect | Equivalence to HydroSet in filling bone defects (histology-based) | MONTAGE-QS performance for cranioplasty was judged to be equivalent to HydroSet. |
| Bench Testing | Visual Inspection (Putty component color) | Met specification | Putty color met specification. |
| Putty Stiffness | Met specification | Putty stiffness met specification. | |
| Putty Vitamin E Acetate Concentration | Met specification | Putty vitamin E acetate concentration met specification. | |
| Hand Mixing Time | Met specification (related to mixing time, stickiness, mixability) | Mixing time, stickiness, and mixability met specification. | |
| Hand Mixing Stickiness | Met specification (related to mixing time, stickiness, mixability) | Mixing time, stickiness, and mixability met specification. | |
| Mixability | Met specification (related to mixing time, stickiness, mixability) | Mixing time, stickiness, and mixability met specification. | |
| Package Leak Test | All test articles passed | All test articles passed. | |
| Temperature Sensitivity | Acceptable maximum temperature increase following hand-mixing | Acceptable maximum temperature increase following hand-mixing. | |
| Water Uptake, Swelling, and Dissolution | Acceptable water uptake, swelling and dissolution | Acceptable water uptake, swelling and dissolution. | |
| In-Vivo Testing | Histopathologic evaluation (critical sized cranial bone defect) | Substantial equivalence to predicate device (HydroSet) through histopathologic evaluation | Substantial equivalence was assessed from histopathologic evaluation (compared to predicate). |
| Biocompatibility | ISO 10993 (Cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, neurotoxicity) | Compliance with ISO 10993 recommendations | Conducted in accordance with ISO 10993 recommendations and GLP requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Efficacy Evaluation (Cranioplasty): The study was conducted in a "rabbit cranial critical-sized defect model." The specific number of rabbits or defects studied is not provided.
- Bench Testing: The sample sizes for each bench test are not specified.
- In-Vivo Testing: Similar to the efficacy evaluation, it refers to an "animal model" without giving specific numbers.
- Data Provenance: The document states "rabbit cranial critical-sized defect model" and "in-vivo animal testing," indicating the data is from preclinical animal studies. The country of origin and whether it was retrospective or prospective data are not specified.
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)
- The "ground truth" for this device's evaluation (e.g., whether bone defects were filled, or histopathological assessments) would have been established by experts in veterinary pathology or relevant scientific fields. However, the document does not state the number of experts or their qualifications. The assessments are described as "histology-based assessments" and "histopathologic evaluation."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method for establishing ground truth or evaluating the test results.
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
- This is a submission for a bone putty, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a submission for a bone putty, not an AI or software device. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the efficacy and in-vivo testing, the ground truth was based on histopathologic evaluation in an animal model. For bench testing, it was based on measurable physical and chemical properties against predetermined specifications.
8. The sample size for the training set
- This is a submission for a physical medical device (bone putty), not an AI or software device. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is demonstrated through testing against specifications and comparison to a predicate, not by training an algorithm.
9. How the ground truth for the training set was established
- As a training set is not applicable for this type of device, the method for establishing its "ground truth" is not applicable.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).