(32 days)
Allogran-N™ is intended for use as a bone void filler or bone void substitute that are not intrinsic to the stability of the bony for bony voids or gaps structure.
Allogran-N™ is to be packed into bony voids or gaps in the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. Allogran-N™ is completely incorporated with new bone during the healing process.
Allogran-N™ Bone Void Filler is a hydroxyapatite bone graft substitute for the repair of bony defects. The granules are provided sterile for single patient use. When the Allogran-N™ granules are placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.
The provided document is a 510(k) summary for the device Allogran-N™ Bone Void Filler and the FDA's clearance letter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with predefined acceptance criteria and performance data in the same way a PMA (Premarket Approval) submission would.
Therefore, the requested information regarding detailed acceptance criteria, specific device performance against those criteria, sample sizes for test sets, data provenance, expert panels, and various types of clinical studies (MRMC, standalone) in the typical sense of a clinical trial will not be available in this document.
However, based on the provided text, I can infer and summarize what is stated about its "acceptance" and "proof."
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, formal "acceptance criteria" in the sense of predefined statistical targets for a specific clinical outcome study are not presented. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The "performance" is qualitative, asserting the device performs similarly to its predicates.
| Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Qualitative) |
|---|---|
| Material Composition | Meets standard for implantable hydroxyapatite. Equivalent to predicate devices. (Non Clinical Testing) |
| Functional Mechanism | New bone grows in apposition to the implant, filling pores, completely incorporated into new bone during healing. Equivalent to predicate devices. |
| Safety | "Well tolerated" and "no adverse events have been reported" over 6 years of clinical use. Implied to be equivalent to predicate devices. |
| Effectiveness | "Completely incorporated into the defect site into which it is implanted" and "safe and effective when used as indicated." Implied to be equivalent to predicate devices. |
| Indications for Use | Same as predicate devices. |
| Risks/Adverse Events | Same as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No specific "test set" of patients was used in a controlled clinical trial for proving performance against a statistical endpoint. The "test set" is essentially the real-world usage over 6 years.
- Data Provenance: Clinical use for the past 6 years (retrospective observation). Country of origin is not explicitly stated for this clinical use, but the applicant is based in the UK.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was not a study that involved establishing ground truth by experts in the typical sense (e.g., adjudicating images). The "ground truth" for the aggregated clinical experience is derived from lack of reported adverse events over 6 years in general clinical practice.
4. Adjudication Method for the Test Set
Not applicable. There was no formal adjudication process described for the 6 years of clinical use in the context of a clinical study. Adverse events are typically reported through established post-market surveillance mechanisms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (bone void filler), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating safety and effectiveness relied on:
- Chemical composition standards: Meeting established standards for implantable hydroxyapatite (non-clinical testing).
- Historical clinical use/Outcomes data: Six years of previous clinical use without reported adverse events. This functions as a form of real-world "outcomes data" to support safety and acceptable performance.
- Substantial equivalence: The primary ground for clearance is equivalence to existing, legally marketed predicate devices, implying their established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable as this is not a machine learning model. If interpreted as the "training" for the substantial equivalence claim, it would refer to the existing preclinical and clinical evidence on the predicate devices, for which no sample size is provided here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" ground truth in the context of this 510(k) submission. The "ground truth" for the predicate devices is implied by their FDA clearance based on their own safety and effectiveness data (which may or may not have been presented in similar 510(k)s or PMAs).
§ 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.