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510(k) Data Aggregation
(135 days)
Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.
Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for Allogran-R® does not explicitly state specific quantitative acceptance criteria or performance metrics that the device was designed to meet. Instead, the basis for clearance is substantial equivalence to predicate devices. This means that the device's performance is deemed acceptable because it is similar enough to devices already legally marketed, which are themselves considered safe and effective.
Therefore, the table below reflects this approach:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantially equivalent in safety and effectiveness to predicate devices | "Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness." |
| No new concerns regarding safety and effectiveness | "No new concerns have been identified regarding safety and effectiveness of Allogran-R®" |
| Meeting intended use for filling bony voids/gaps | "Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure..." (Matches predicate intent) |
| Technological characteristics similar to predicates | "Allogran-R® has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific "test set" in the context of a clinical study with human subjects. The 510(k) relies on "Non Clinical Testing" and comparison to predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature for a clinical test set are not available in this filing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no mention of a human-subject clinical "test set" requiring ground truth establishment by experts, this information is not provided in the document.
4. Adjudication Method for the Test Set
As there is no mention of a human-subject clinical "test set" and expert ground truth, an adjudication method is not applicable or mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study is not mentioned or indicated in the provided 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical component.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This device (Allogran-R®) is a medical implant, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
For this device, the "ground truth" for demonstrating substantial equivalence primarily relies on:
- Established safety and effectiveness of the predicate devices: The predicate devices (Vitoss Scaffold and βGran) were already cleared, implying their safety and efficacy were accepted.
- Non-clinical testing: The document mentions "Test data supplied," which typically refers to in-vitro studies, material characterization, biocompatibility testing, mechanical testing, and potentially animal studies, demonstrating the device's properties are acceptable and comparable to predicates.
8. The Sample Size for the Training Set
The concept of a "training set" is usually associated with machine learning algorithms. Since Allogran-R® is a medical implant and not an AI/ML device, a training set in that context is not applicable and therefore not provided.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a training set is not applicable to this type of device.
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