(84 days)
DBX® 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 in the:
| Putty | Mix | Paste |
|---|---|---|
| Extremities | Extremities | Extremities |
| Pelvis | Pelvis | Pelvis |
| Posterolateral Spine | Spine | |
| Cranium | ||
| DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® Mix may be used as a bone void filler in the spine. DBX® can be used with bone marrow. DBX® is for single patient use only. |
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of cadaveric cortical bone; the DBX® Mix is composed of cadaveric corticocancellous bone. The bone granules are mixed with sodium hyaluronate (NaHy) in varying combinations to form the DBX® Putty, Paste, and Mix. DBX® Putty is available in five sizes and DBX® Paste and Mix are available in four sizes.
The provided text does not contain detailed information about a study proving the device meets specific quantitative acceptance criteria in a robust clinical or comparative effectiveness setting. Instead, it focuses on the device's characteristics, safety aspects, and regulatory approval processes.
Here's a breakdown of the available information and what's missing, formatted to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the primary "acceptance criteria" are related to biocompatibility and osteoinductive potential for lot release. There are no specific quantitative performance metrics like sensitivity, specificity, or improvement effect sizes from a clinical study.
| Acceptance Criteria (Stated) | Reported Device Performance (Implied/Stated) |
|---|---|
| Biocompatibility | Established through long history of safe/effective clinical use & ISO 10993 testing. |
| Sterility | Tested per current USP . |
| Osteoinductivity Potential (Lot Release) | "Standard testing performed in an athymic mouse must prove positive for lot release." |
| Viral Clearance/Inactivation | Processing methods determined to provide "significant viral inactivation potential." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study as described by the text. The "test set" mentioned refers to individual lots of the product being tested for osteoinductivity. The number of samples (e.g., mice) used for this per lot is not specified.
- Data Provenance: Not applicable for a clinical performance study. The osteoinductivity testing is described as an in vivo assay in an athymic mouse model, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable as there is no human-involved "test set" for performance evaluation described in the provided text. The ground truth for osteoinductivity is established via the athymic mouse model.
4. Adjudication Method for the Test Set
- This question is not applicable as there is no human-involved "test set" for performance evaluation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not conducted or reported. The document focuses on regulatory approval based on substantial equivalence to predicate devices, safety, and laboratory/animal testing, not a clinical effectiveness study comparing human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone algorithm performance study was not done. This device is a medical product (bone void filler), not an AI algorithm.
7. The Type of Ground Truth Used
- Osteoinductivity: In vivo assay results in an athymic mouse model.
- Biocompatibility: Demonstrated through in vitro laboratory testing (ISO 10993) and a history of clinical use.
- Sterility: USP testing.
- Viral Clearance: Laboratory evaluation of processing methods using model viruses.
8. The Sample Size for the Training Set
- Not applicable. This product is a medical device (bone void filler), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI algorithm is involved.
Summary of Device Evaluation in the Provided Text:
The document describes the DBX® Demineralized Bone Matrix device, its composition, indications for use, and a summary of its safety and effectiveness based on:
- Biocompatibility: Established by a long history of safe and effective clinical use and ISO 10993 laboratory testing.
- Sterility: Tested per USP .
- Osteoinductive Potential: Assayed in vivo in an athymic mouse model. This is used as a lot-release criterion, meaning every lot of the final product must test positive for osteoinductive potential. However, the document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects."
- Viral Clearance and Inactivation: Evaluation of the DBM processing method for its ability to inactivate a panel of model human viruses.
The FDA's decision to clear the device (K063676) is based on substantial equivalence to legally marketed predicate devices, not on the demonstration of specific clinical performance criteria from a new clinical study.
§ 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.