(679 days)
MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. 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 bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The provided text describes the Montagne Settable, Resorbable Hemostatic Bone Putty. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific, quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, success rate within a defined timeframe). Instead, it states more general performance outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to achieve hemostasis | "Studies have been conducted which demonstrate that Montage can achieve hemostasis..." |
| Acceptable bone remodeling | "...and allows for acceptable bone remodeling." |
| Biocompatibility | "Montage has been previously tested to demonstrate biocompatibility through an appropriate series of studies as required for compliance with ISO 10993." |
| Acceptable handling characteristics | "Montage has been evaluated for handling characteristics..." |
| Acceptable shelf-life/stability | "...and shelf-life / stability." |
| Endotoxicity | "Each lot is evaluated for endotoxicity." |
| Sterility Assurance Level (SAL) | "The device is provided sterile with a Sterility Assurance Level (SAL) of 10-6." |
| Efficacy in sternotomy procedures | "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." (No specific metrics or success rates from this study are detailed in this summary.) |
| Maintenance of technological characteristics vs. predicate | "The technological characteristics of the devices are unchanged. The only change is the addition of a statement regarding the use of the devices in sternotomy procedures." (This is a statement of design intention, implying no performance degradation due to the added indication). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size for this clinical evaluation, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set of the clinical evaluation.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention or describe a MRMC comparative effectiveness study, nor does it discuss human improvement with or without AI assistance. This is expected as the device is a medical device (putty), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone performance study in the context of an algorithm. This is not applicable to a physical medical device like bone putty.
7. Type of Ground Truth Used:
For the "human clinical evaluation" mentioned, the ground truth would implicitly be clinical outcomes (e.g., successful hemostasis, absence of re-bleeding, safety events) as observed and documented by the operating surgeons and medical staff. However, the document does not explicitly state the specific ground truth used. For other performance tests (biocompatibility, sterility, etc.), the ground truth would be established through standardized testing protocols and laboratory measurements as per ISO 10993 and other relevant standards.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. As a physical medical device (bone putty) undergoing a 510(k) submission, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance is typically established through a combination of bench testing, animal studies (if applicable), and clinical evaluation.
9. How the Ground Truth for the Training Set Was Established:
Since there is no "training set" in the context of an algorithm, this question is not applicable. The performance characteristics for the device were likely established through the aforementioned laboratory tests and clinical evaluation, with ground truth based on observed biological or physical responses to the device.
In summary, the provided document is a 510(k) summary focused on substantial equivalence for a medical device. It briefly mentions performance testing and a clinical evaluation but lacks specific details typically found in summaries for AI/ML-powered devices, such as sample sizes, expert qualifications, or detailed performance metrics. The main purpose of this 510(k) was to add a new indication for use (sternotomy procedures) based on demonstrated equivalence to the previously cleared version of the same device and a predicate device.
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