(109 days)
Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
The Accell Evo3c™ is an extension to the Accell Family of products cleared under 510(k) K061880. The Accell Family of products, including Accell Evo3c™, contain human demineralized bone matrix (DBM) in particulate and dispersed forms. The Accell Evo3c™ is the same as Accell A2i, submitted under 510(k) K061880, with the exception of the inclusion of cancellous bone chips which are added as an osteoconductive scaffold. The Accell A2i is marketed under the brand name "Accell Evo3™," hence the "c" in Accell Evo3c™ denotes the inclusion of cancellous chips in the formulation.
This document is a 510(k) summary for the ACCELL EVO3C™ bone void filler, asserting its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.
Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating "substantial equivalence" of a new medical device to a predicate device, as per FDA's 510(k) pathway. The "study that proves the device meets the acceptance criteria" refers to the verification testing and characterization that supports this claim of substantial equivalence.
Here's an breakdown based on the provided text, recognizing that the context is a regulatory submission for a bone void filler, not an AI or diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is not a diagnostic AI device, there are no typical performance metrics like sensitivity, specificity, or AUC with corresponding acceptance criteria. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in terms of technical characteristics, safety, and functionality compared to predicate devices. The "reported device performance" refers to the results of various tests demonstrating these equivalencies.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use. | Accell Evo3c™ has the same intended use as predicate devices: "filling voids and gaps in the skeletal system... as a bone graft extender... or as a bone void filler..." |
| Principle of Operation Equivalence: Similar mechanism. | Accell Evo3c™ utilizes human demineralized bone matrix (DBM) in particulate and dispersed forms, similar to the Accell Family of products. The primary difference is the addition of cancellous bone chips for osteoconductivity, which does not alter the fundamental principle of operation as a resorbable bone void filler. |
| Technological Characteristics Equivalence: Similar materials, processing, and functional properties. | - Composition: Contains human demineralized bone matrix (DBM) and cancellous bone chips. This is an extension of the Accell Family (K061880), specifically Accell A2i, with the added cancellous chips. |
- Osteoinductive Potential: Each lot of DBM is tested using a quantitative in vitro assay validated to correlate with an athymic mouse osteoinductive potential assay.
- Viral Inactivation Validation: Methods for processing DBM were evaluated for viral inactivation potential against a panel of viruses, demonstrating suitable inactivation. The cancellous bone component, while not demineralized, is processed in AATB-recommended antimicrobial, antiviral, and antiseptic solutions, and multiple safeguards (donor screening, serologic testing, tissue cleaning, terminal sterilization) are in place to mitigate viral transmission risk. |
| Safety and Effectiveness: No new questions of safety/efficacy. | "All necessary verification testing has been performed for the Accell Evo3c™ product to assure substantial equivalence to the predicate device." The viral inactivation validation demonstrates safety measures against potential pathogens. |
"Study That Proves the Device Meets the Acceptance Criteria":
The "study" cited is the sum of verification testing performed for the Accell Evo3c™ product, specifically mentioned under "5.5 Performance Data". This testing aimed to assure substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
This is not applicable in the context of an AI device's test set for a 510(k) submission of a bone void filler.
- The "test set" here refers to the materials used in the specific verification tests (e.g., lots of DBM, samples of cancellous bone).
- For Osteoinductive Potential, each "lot of DBM" is tested. The specific number of lots or samples per lot is not provided. The testing involves an in vitro assay validated against an athymic mouse osteoinductive potential assay.
- For Viral Inactivation Validation, "a selected panel of viruses representing various virus types, sizes, shapes and genomes" was evaluated. The exact number of viruses or samples is not specified.
- Data Provenance: The human DBM is from human donors. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are lab-based verification tests rather than clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. "Ground truth" in the context of this device refers to the established biological and material properties, rather than expert consensus on diagnostic imaging. The "truth" of osteoinductivity is determined by validated in vitro and in vivo (athymic mouse) assays. The efficacy of viral inactivation is determined by established microbiological validation methods.
4. Adjudication Method for the Test Set:
Not applicable. There is no expert adjudication for these types of material property tests. The tests themselves provide objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is a bone void filler, not a diagnostic imaging device with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- Osteoinductive Potential: The ground truth is established through a quantitative in vitro assay that has been "validated to correlate to an athymic mouse osteoinductive potential assay." So, an in vitro assay correlated to an animal model.
- Viral Inactivation Validation: The ground truth is the demonstrable reduction or inactivation of a "panel of viruses" by the processing methods, measured using standard microbiological validation techniques.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (bone void filler) and not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
§ 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.