(90 days)
Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
The Accell TBM-R is an extension to the Accell Family of Products 510(K) K061880. The Accell Family of Products, including Accell TBM-R, contain human demineralized bone matrix (ground, demineralized cortical bone). The Accell TBM-R is an addition to the Accell product family which has improved ease of use in handling characteristics and manual manipulation of the device.
The provided document describes a Bone Void Filler device called Accell TBM-R, which is an extension of the existing Accell Family of Products. This is a 510(k) submission, indicating a focus on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish novel performance criteria. Therefore, the information typically found in a study demonstrating how a device meets specific acceptance criteria for a novel AI/medical imaging device is largely absent.
Below is an analysis based on the provided text, highlighting what is available and what is not in the context of your request:
Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of bone healing). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence | Accell TBM-R is determined to be substantially equivalent in intended use, principal of operation, and technological characteristics to the predicate Accell Family of Products (K061880). |
| Osteoinductive Potential | Each lot of DBM (demineralized bone matrix) in Accell TBM-R is tested in vitro for osteoinductive potential. This in vitro assay is validated to correlate with an athymic mouse osteoinductive potential assay. |
| Viral Inactivation | The processing methods for DBM in Accell TBM-R were evaluated for viral inactivation potential using a panel of viruses, demonstrating suitable inactivation. |
| Safety and Efficacy (General) | "All necessary verification testing has been performed for the Accell TBM-R product to assure substantial equivalence to the predicate device as well as safety and efficacy." (This is a general statement, not specific performance data.) |
| Intended Use | Accell TBM-R shares the same intended uses as the predicate devices: filling voids/gaps in the skeletal system, bone graft extenders, bone void fillers, or bone graft substitutes in extremities, pelvis, and spine (e.g., posterolateral spine fusion) for surgically created defects or traumatic injuries. |
| Technical Characteristics | Accell TBM-R utilizes ground and demineralized human cortical bone (DBM), similar to the predicate, with improved ease of use and handling characteristics. The DBM exhibits osteoinductive potential in validated animal and/or in vitro models. |
Study Information (as requested for an AI/Medical Imaging Device)
Based on the provided text, the following aspects related to a "study proving the device meets acceptance criteria" for an AI/Medical Imaging device are not applicable or not present:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes a medical device (bone void filler), not an AI/medical imaging device that would typically have a test set of data. The "test set" here refers to the verification tests for the material properties and biological aspects of the DBM and the product itself.
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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. "Ground truth" in the context of an AI/medical imaging device usually refers to expert interpretation of medical images or pathology results. For this bone void filler, the "ground truth" for certain characteristics would be established by scientific testing and biological assays.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical images, which is not the subject of this submission.
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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: Not applicable. This is not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone void filler material, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductive potential, the "ground truth" is a correlation to an athymic mouse osteoinductive potential assay which is considered a validated model. For viral inactivation, the "ground truth" is the effective reduction of a selected panel of viruses. For ease of use/handling, the implied "ground truth" is user feedback or internal assessment comparing it to the predicate.
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The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable.
Summary of Relevance
This 510(k) submission for Accell TBM-R focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Similar intended use.
- Similar technological characteristics (composition, principle of operation).
- Laboratory testing for biological activity (osteoinductive potential correlating to an animal model) and safety (viral inactivation).
- Improved handling characteristics, which generally means improved ergonomics and ease of application for the user.
The document does not contain the type of clinical study data with detailed acceptance criteria, sample sizes, and ground truth establishment that would be typically found for a novel AI/medical imaging device. The "proof" of meeting "acceptance criteria" is primarily the demonstration of equivalence through bench testing and comparison to predicates, which is standard for 510(k) submissions of this type of medical device. The "acceptance criteria" are broad and relate to safety, efficacy (as demonstrated by biological function and equivalence), and intended use.
§ 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.