(107 days)
DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.
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. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Inject can be used alone in the pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.
DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
DBX Inject is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
The provided text describes two medical devices, DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. Both are bone void fillers containing human demineralized bone matrix (DBM) and sodium hyaluronate. The 510(k) submission (K103784) was for an expansion of their indications for use in the pelvis and extremities, specifically allowing their use with autograft or allograft.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Safety | Biocompatibility | Established through long history of safe and effective clinical use and laboratory testing per ISO 10993. |
| Sterility | Single-donor processed using aseptic techniques and tested for sterility per current USP . | |
| Viral Clearance & Inactivation | Processing methods evaluated for viral inactivation potential against a panel of model human viruses; determined to provide significant viral inactivation potential. | |
| Effectiveness | Osteoinductive Potential | Each lot of final product (Putty/Inject) is tested in an athymic mouse model or an alkaline phosphatase assay (which correlates with the mouse model) to ensure osteoinductive potential. Standard testing must prove positive for lot release. (Note: Correlation with human clinical performance is unknown.) |
| Equivalence for expanded indications | Recent in vivo studies conducted by MTF demonstrate that the use of DBX Putty/Inject with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Putty/Inject alone. |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "Recent in vivo studies conducted by MTF" for the equivalence assessment of the expanded indications. However, it does not provide the sample size for these in vivo studies.
The data provenance for these in vivo studies is not explicitly stated in terms of country of origin, nor whether they were retrospective or prospective. Given that they are described as "recent in vivo studies conducted by MTF," it implies a prospective study design primarily for this submission.
For the osteoinductive potential testing, the "test set" is described as "Every lot of final DBX Putty/Inject product." This is a continuous quality control measure rather than a single study with a fixed sample size. The testing is done in an "athymic mouse model" or an "alkaline phosphatase assay."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the in vivo equivalence studies. For the osteoinductive potential, the "ground truth" is defined by the outcome of the athymic mouse model or alkaline phosphatase assay, which are objective biological tests rather than expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the in vivo equivalency studies or for the osteoinductive potential testing. These processes appear to rely on direct measurement or observation rather than subjective review requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No MRMC comparative effectiveness study was done as this device is a bone void filler, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical bone void filler, not a software algorithm or AI-based diagnostic tool. The performance evaluation focuses on its biological and physical properties in in vivo models, not on an algorithm's performance.
7. The Type of Ground Truth Used
- For Equivalence for expanded indications: The ground truth is established by the outcome of the "in vivo studies" demonstrating equivalence to the predicate (DBX Putty/Inject alone). The specific metrics or "ground truth" criteria for equivalence (e.g., bone formation, histological assessment) are not detailed in the provided text.
- For Osteoinductive Potential: The ground truth is the outcome of the "athymic mouse model" or the "alkaline phosphatase assay." These are biological assays that provide a quantitative or qualitative result indicative of osteoinduction.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. These devices are regulated based on their physical and biological properties and performance in in vivo models, not on machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for these types of medical devices.
§ 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.