(154 days)
DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
| Indications for Use | Putty | Paste |
|---|---|---|
| Extremities | √ | √ |
| Posterolateral spine | √ | |
| Pelvis | √ | √ |
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.
DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.
The provided text is a 510(k) summary for the DBX® Inject device, a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen in studies for diagnostic or AI-powered devices.
Therefore, the information required to populate the requested table and answer the study-related questions for a device performance study as described in the prompt is not present in the provided document. The 510(k) summary describes regulatory compliance, device characteristics, and comparisons to predicate devices.
However, I can extract information related to the device's biological potential and safety testing, which are forms of performance evaluation for this type of medical device.
Here's what can be gathered from the document, acknowledging the difference in scope from the prompt's implied request for clinical performance study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as described for regulatory purposes) |
|---|---|
| Osteoinductive Potential: | |
| Lot release must prove positive in athymic mouse model or alkaline phosphatase assay. (Positive correlation between alkaline phosphatase assay and athymic mouse model shown). | Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. |
| Viral Clearance and Inactivation: | DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses. |
| Donor Suitability: | In compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation. |
| Substantial Equivalence to Predicate Devices: | DBX® Inject has been demonstrated to be substantially equivalent to DBX® Demineralized Bone Matrix [K040262] and Sygnal™ DBM [K080405], with no new types of safety and effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical study on device performance in humans. The testing mentioned is for lot release (biological properties) and viral inactivation.
- For osteoinductive potential: "Every lot of final DBX® Inject Paste will be assayed," and "Every lot of final DBX® Inject Putty product will be tested." The specific number of samples per lot test is not provided, nor is the number of lots tested in the submission.
- For viral clearance: A "panel of model potential human viruses" was evaluated. The specific number of virus types/samples used is not detailed.
- Data Provenance:
- Osteoinductive potential: In vivo (athymic mouse model) and in vitro (alkaline phosphatase assay).
- Viral clearance: In vitro (evaluated DBM processing methods).
- Donor suitability: Refers to compliance with FDA regulations for human tissue donors.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth here relates to biological activity (osteoinductivity) and viral inactivation, which are determined by laboratory assays and scientific protocols, not expert consensus on interpretations of images or clinical outcomes.
4. Adjudication Method for the Test Set:
- Not applicable. This concept applies to human expert adjudication in clinical or diagnostic studies. The tests mentioned are laboratory-based.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images), and the device aims to assist or improve their performance. DBX® Inject is a bone void filler, not a diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No, a standalone performance study in the context of an algorithm or AI is not applicable. DBX® Inject is a physical medical device. The "performance" evaluated relates to its biological properties and manufacturing safety.
7. The Type of Ground Truth Used:
- Osteoinductive Potential: The "ground truth" is established by the qualitative result of the athymic mouse model (positive/negative for osteoinductivity) or the alkaline phosphatase assay, which is correlated to the mouse model. This is a scientific, biological assay result.
- Viral Clearance: The "ground truth" is the measured reduction/inactivation of various model viruses by the DBM processing methods. This is based on laboratory virology assays.
- Donor Suitability: Compliance with regulatory standards (21 CFR Part 1270 and Part 1271).
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The biological tests are on the final product lots.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of device submission.
In summary: The provided 510(k) summary for DBX® Inject addresses its safety and effectiveness through demonstrating substantial equivalence to predicate devices, biological activity (osteoinductive potential), and viral inactivation capabilities. It does not contain information on clinical trials with human subjects, device performance metrics, or reader studies that would typically apply to diagnostic or AI-powered devices. The "studies" described are primarily laboratory-based assessments of the product's inherent properties and manufacturing process safety.
§ 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.