(27 days)
OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
OSTEOSET® DBM Pellets are a bone graft material. OSTEOSET® DBM Pellets combine the effects of DBM and OSTEOSET® Pellets. The DBM used in OSTEOSET® DBM Pellets is tested to confirm the osteoinductivity of each DBM lot.
OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.
The provided text describes a 510(k) summary for the OSTEOSET® DBM Pellets, a bone void filler. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating achievement of specific acceptance criteria in the way a new, high-risk device might.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" for the OSTEOSET® DBM Pellets in terms of clinical performance (e.g., bone healing rates, reduction in pain). Instead, it describes performance related to the materials and manufacturing processes that support its substantial equivalence claim.
| Acceptance Criteria (related to materials/processes) | Reported Device Performance |
|---|---|
| Purity/Composition | OSTEOSET® DBM Pellets combine DBM and OSTEOSET® Pellets (calcium sulfate). |
| Osteoinductivity Potential (of DBM component) | Each lot of DBM is assayed using: |
- in vitro assay (human bone forming cells) correlated to athymic rat model and clinical results.
- in vitro assay for native protein (BMP-2) correlated to athymic rat model. |
| Viral Inactivation Potential (of DBM processing) | Processing method evaluated with a panel of model human viruses, showing "suitable viral inactivation potential". |
| Resorption Rate | Resorbed in approximately 30-60 days. |
Important Note: The document explicitly states: "The osteoinductivity of this combination of DBM and calcium sulfate (OSTEOSET® Pellets) has not been established; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via either in vitro assay, will correlate with human clinical performance of OSTEOSET® DBM Pellets." This highlights that the "performance" described is largely at the component/material level rather than full device clinical performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of device clinical performance testing. The "tests" mentioned are for raw material (DBM) and processing methods.
- For Osteoinductivity Potential Testing: The "test set" refers to each lot of DBM. The actual sample size of cells or rats used in these assays is not specified, but the methods refer to established models (in vitro human bone forming cells, athymic rat model).
- For Viral Inactivation Potential: A "panel of model potential human viruses" was used. The number of viruses in the panel is not specified.
- Data Provenance: Not explicitly stated for all references.
- Reference 1 (Wilkins, 1999) on DBM effectiveness: likely retrospective analysis on human cell culture and athymic rat model correlations.
- Reference 2 (Lindholm TS, Urist MR, 1980) on bone formation analysis: an animal study (bone marrow and bone matrix grafts).
- Reference 3: "Data on file at Wright Medical Technology, Inc." (manufacturer's internal data), likely derived from laboratory testing of DBM batches.
- Retrospective or Prospective: The viral inactivation and osteoinductivity assays are prospective tests performed on each batch of materials. The referenced studies that correlate these assays to clinical/animal outcomes could be retrospective analyses of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission does not detail human-read imaging or diagnostic performance where expert consensus would be required to establish ground truth. The "ground truth" for the osteoinductivity assays would be the biological response observed (e.g., bone formation in rats, cell differentiation), and for viral inactivation, it would be the reduction in viral titer. These are laboratory-based measurements, not expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of adjudication, as this typically applies to image interpretation or clinical outcome assessment, which are not detailed in this 510(k) summary.
5. 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 device is a bone void filler, a physical implant. The submission does not involve AI or imaging interpretation, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Osteoinductivity Potential: The "ground truth" for the assays is the correlation to the athymic rat model (a biological model for bone formation) and clinical results of DBM (outcomes data). The in vitro assays themselves are surrogates for this biological activity.
- For Viral Inactivation Potential: The "ground truth" is the reduction in viral infectivity/titer directly measured in laboratory experiments with model viruses.
8. The sample size for the training set:
Not applicable. This summary does not describe an AI/machine learning device, so there is no concept of a "training set" in this context. The manufacturing processes and material testing are based on established scientific methods and assays, not iterative learning from data.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set mentioned, this question is not relevant.
§ 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.