(58 days)
Orthocon Montage-QS 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-QS 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-QS 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-QS can be drilled and tapped, and hardware can be placed through it at any time during process.
Montage-QS 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-QS device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage-QS device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
The provided text is an FDA 510(k) summary for a medical device called Montage-QS Settable, Resorbable Bone Putty. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria or a detailed study of the device proving it meets specific acceptance criteria in the format requested.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It mentions some performance data from an animal study and in-vitro testing but not in the context of acceptance criteria. The requested information regarding sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies for a device approval study is not present. This type of detailed study design and results would typically be found in a separate, more comprehensive study report, not a 510(k) summary for a device like a bone void filler which primarily relies on substantial equivalence.
Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document describes a comparison study in rabbits that assessed new bone formation and implant material remaining, but this is presented as efficacy evaluation and not in the context of a formal acceptance criteria study typically seen for AI/software devices.
Here's what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantified acceptance criteria (e.g., "new bone formation must be > X%") for regulatory approval in the way an AI/software device might. It simply presents the results of an animal study comparing the new device to a predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a "test set" sample size. The animal study involved a "Montage-QS group," a "HydroSet predicate group," and an "empty defect negative control group." The number of animals in each group is not provided.
- Data Provenance: An animal study (rabbit critical sized femoral defect model). Country of origin is not specified. It is a prospective study as it involved implanting devices and observing outcomes.
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. This is a hardware device (bone putty), not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is biological outcomes (new bone formation, material resorption) assessed via micro-CT and histopathology/histomorphometry. The qualifications of the personnel performing these assessments are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to human review of AI outputs, which is not relevant for this device.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the animal study (efficacy evaluation) was based on micro-CT and histopathology/histomorphometry assessments to quantify device resorption and new bone formation.
8. The sample size for the training set
- Not applicable / Not mentioned. This is not an AI device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
Summary of available "performance" data (not acceptance criteria):
| Measurement Aspect | Montage-QS Group (Device) | HydroSet Group (Predicate) | Empty Defect Control Group |
|---|---|---|---|
| New Bone Formation (12 weeks) | 17.2% | 12.4% | 10% |
| Implant Material Remaining (12 weeks) | ~75% | ~75% | N/A |
Other relevant performance data mentioned (without specific quantifiable results or acceptance criteria):
- Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced.
- An in-vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished.
- Biocompatibility testing was conducted in accordance with ISO 10993 recommendations (cytotoxicity, irritation, sensitization, systemic toxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity). All conducted to GLP requirements.
- Sterility: Gamma sterilization validated to provide SAL of 10^-9. Each lot tested for bacterial endotoxin for lot release.
§ 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.