(290 days)
DBX-H™ Hemostatic Demineralized Bone Matrix Putty is indicated for use for filling voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis.
DBX-H™ can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used for treatment of surgically created osseous defects and in osseous defects resulting from traumatic injury.
DBX-H Hemostatic 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 calcium stearate (a wax-like material) and triethyl citrate (a dispersing agent). DBX-H Putty is virtually odorless, off.white in color and can be spread easily with minimal adhesion to surgical gloves.
The provided 510(k) summary for K061131, concerning the DBX-H™ Hemostatic Demineralized Bone Matrix Putty, does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of device performance as would typically be seen for AI/ML devices.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device, rather than proving performance against pre-defined numerical thresholds for a specific clinical task.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or available in this document. This is common for submissions of this era and type (medical device, not AI/ML).
Here's an analysis based on the information provided, highlighting what is present and what is not:
Acceptance Criteria and Device Performance Study (Not Applicable for this Submission Type)
The 510(k) summary for DBX-H™ Hemostatic Demineralized Bone Matrix Putty does not present acceptance criteria or a dedicated study proving performance against such criteria in the way an AI/ML device submission would. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This involves showing that the new device has the same intended use, technological characteristics, and performs comparably in terms of safety and effectiveness, leveraging existing knowledge and data for the predicate devices.
The document states: "The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results and biocompatibility testing. The data presented demonstrate that the device is biocompatible and is suitable for its indicated use." However, specific numerical performance metrics, acceptance criteria, or detailed study designs for these tests are not provided in this summary.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated/not applicable for this type of submission) | Reported Device Performance (General statements from submission) |
|---|---|
| Not specified as numerical targets for clinical performance. | Biocompatibility: "The data presented demonstrate that the device is biocompatible." |
| Not specified as numerical targets for clinical performance. | Functionality (Efficacy): "The data presented demonstrate that the device...is suitable for its indicated use [filling voids, controlling bleeding by mechanical barrier/tamponade]." |
| Not specified as numerical targets for clinical performance. | Mechanical Barrier/Tamponade: "DBX-H™ can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade." |
| Not specified as numerical targets for clinical performance. | Absorption: "The putty will be dispersed and absorbed through exposure to body temperature, body fluids and cellular transport within a period of 90 days." |
Detailed Study Information (Not available/not applicable for this submission type)
Given that this 510(k) is for a physical medical device (bone void filler) and relies on substantial equivalence rather than a new performance claim validated by a clinical study with detailed statistical targets, most of the requested information regarding study methodologies for AI/ML devices is not present.
- Sample size used for the test set and the data provenance: Not applicable/not provided. Performance data would typically come from physical and functional/biocompatibility testing, not a "test set" as understood in AI/ML. There is no mention of a clinical or observational study that would generate such a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No "ground truth" establishment in the context of clinical reads or diagnostic accuracy is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
- 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 not an AI algorithm assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. "Ground truth" for biocompatibility and functionality would rely on established scientific methods and in vitro/in vivo testing results according to recognized standards, rather than expert consensus on diagnostic images or pathology.
- The sample size for the training set: Not applicable/not provided. There is no "training set" in the AI/ML sense for this device.
- How the ground truth for the training set was established: Not applicable/not provided.
Summary of Approach:
The submission for DBX-H™ Hemostatic Demineralized Bone Matrix Putty relies on demonstrating substantial equivalence to previously cleared predicate devices (DBX® Demineralized Bone Matrix Putty and Grafton DBM). The "study" in this context refers to standard physical, functionality, and biocompatibility testing, the results of which are summarized but not detailed in this 510(k) document. The core argument is that, because its intended use and technological characteristics are similar to already approved products, and it passes standard safety tests, it should be considered substantially equivalent.
§ 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.