(129 days)
OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.
The provided text describes a 510(k) premarket notification for the OsteoSelect™ Demineralized Bone Matrix Putty. It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically associated with studies demonstrating AI or software device performance (e.g., sensitivity, specificity, or reader performance metrics).
However, the document does describe the "study" and "acceptance criteria" in the context of demonstrating substantial equivalence to predicate devices, focusing on the material's properties and biological activity.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Accepted) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Equivalence to predicate devices (DBX®, Grafton® DBM) in intended use, technology, and performance. | The submission "supports the position that OsteoSelectтм Demineralized Bone Matrix Putty is substantially equivalent". |
| Biocompatibility | Device is biocompatible. | "The data presented demonstrate that the device is biocompatible." |
| Functionality (Efficacy) | Osteoinductive potential in an in vivo model. Osteoconductive. | "OsteoSelect™ DBM Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic rat model." |
| Viral Inactivation | Processing methods provide significant viral inactivation potential. | "The methods used for processing the DBM used in the device have been tested and validated for viral inactivation potential. A panel of model potential human viruses... was evaluated. The processing methods were determined to provide significant viral inactivation potential for a wide range of viruses." |
| Absorption Time | Absorption within 90 days. | "The putty will be absorbed within a period of 90 days." |
| Physical Characteristics | Putty-like consistency, virtually odorless, tan in color, easy to spread with minimal adhesion to surgical gloves. | "The combination... results in a putty-like consistency for ease and flexibility of use... OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves." |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Viral Inactivation: A "panel of model potential human viruses" was used. The exact number of viruses is not specified.
- Osteoinductivity: "an athymic rat model" for testing, and "Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model". The exact sample size (number of rats) for the initial testing or for lot release is not specified.
- Physical/Biocompatibility/Absorption: Not specified, but likely involved laboratory testing of the material, not a "test set" in the sense of a clinical dataset.
- Data Provenance: The document does not specify country of origin for the data. The studies are described as pre-clinical (in vivo rat model, in vitro viral inactivation). They are not human clinical trials data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to the type of device and studies described. The ground truth for this medical device (a bone void filler) is established through laboratory and animal model testing, not through expert review of clinical images or data.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving multiple human readers for diagnostic accuracy assessments. The described studies are pre-clinical (viral inactivation, animal models).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not mentioned and would be irrelevant for this kind of medical device. MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing human reader performance with and without the tool on a set of cases.
6. Standalone Performance Study
Yes, in a way. The studies described (viral inactivation, osteoinductive potential in rats, physical properties, biocompatibility) are assessments of the device's inherent properties and performance without human-in-the-loop interaction for diagnostic purposes. These are "standalone" in the sense that they evaluate the device itself.
7. Type of Ground Truth Used
- Viral Inactivation: Laboratory assay results determining the reduction in viral titer.
- Osteoinductivity: Histological and/or other biological markers observed in the athymic rat model, indicating new bone formation.
- Biocompatibility: Results from standard biocompatibility tests (e.g., cytotoxicity, sensitization, irritation).
- Physical Properties: Laboratory measurements of consistency, color, adhesion, etc.
8. Sample Size for the Training Set
Not applicable. This device is a bone void filler, not an AI or software algorithm that requires a "training set" in the machine learning sense. The "training set" concept is irrelevant to the development of this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this 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.