(205 days)
Orthocon MONTAGE Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, MONTAGE may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
The provided text describes a 510(k) premarket notification for a medical device called MONTAGE Settable, Resorbable Bone Putty. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for device performance. Therefore, many of the requested points, particularly those related to clinical study design, expert involvement, and ground truth establishment, are not applicable or cannot be extracted from this document.
However, I can extract information related to the animal study and performance testing that was conducted.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence rather than explicit performance acceptance criteria for a new clinical indication, formal acceptance criteria in the traditional sense are not explicitly stated for all performance aspects. The studies aim to demonstrate that MONTAGE performs similarly to or better than the predicate device.
| Performance Metric | Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (MONTAGE) |
|---|---|---|
| New Bone Formation (Rabbit Femoral Defect Model at 12 weeks) | Similar to or better than predicate device (HydroSet XT, 12.4%) and negative control (10%) | 16.1% |
| Implant Material Remaining (Rabbit Femoral Defect Model at 52 weeks) | Similar to predicate device (HydroSet XT) | Approximately 70% |
| Drillability without fragmenting/displacement | Device can be drilled when hardened without fragmenting or displacement | Device performed as expected, allowing for use with provisional hardware |
| Temporary Support during Complex Repair | Device provides temporary support until permanent hardware fixation | Device performed as expected, providing temporary support |
| Biocompatibility | Meets ISO 10993 recommendations (cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity) | All tests conducted were in accordance with GLP requirements and recommendations, suggesting successful completion. Labeling adjustment regarding Vitamin E acetate based on CDER assessment. |
| Sterility | SAL of 10^-6 (Standard for medical devices) | SAL of 10^-9 (exceeds standard) |
| Bacterial Endotoxin | Lot release criteria met | Each lot is tested and meets release criteria |
2. Sample size used for the test set and the data provenance
- Animal Study: The sample size for the rabbit critical sized femoral defect model is not explicitly stated as a number of animals, but refers to "MONTAGE group," "HydroSet predicate group," and "empty defect negative control group." No specific numbers are given per group.
- Data Provenance: The animal study was conducted in a laboratory setting, likely in the country of the manufacturer or a contract research organization. The document does not specify the country. It is a prospective animal study. Other performance data are from in vitro studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Animal Study: The histopathology/histomorphometry assessments would typically be performed by veterinary pathologists or experts in bone histology. The document does not specify the number or qualifications of these experts.
- Other Performance Tests: These were likely evaluated against engineering specifications or known material properties, not by human experts establishing ground truth in the clinical sense.
4. Adjudication method for the test set
- Animal Study: Not specified. Histopathology and micro-CT assessments would likely involve independent evaluation, but no formal adjudication process like "2+1" or "3+1" is mentioned.
- Other Performance Tests: Not applicable, as these are technical performance assessments rather than interpretations requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a bone void filler, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone putty), not an algorithm.
7. The type of ground truth used
- Animal Study: The "ground truth" for the animal study was based on quantitative measurements from micro-CT and qualitative/quantitative assessments from histopathology/histomorphometry to determine new bone formation and implant resorption.
- Other Performance Tests: The "ground truth" for drillability and temporary support was established through engineering performance tests comparing the device's physical behavior against predetermined functional expectations.
- Biocompatibility: The "ground truth" was established by adherence to ISO 10993 standards and their associated endpoints.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set." The development of the material involved formulation and testing, but not in the context of a "training set" for AI.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
§ 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.