Search Results

DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-Composite Bone Void Filler is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3cc, 5cc, and 10cc DB-Composite Bone Void Filler Kits are provided sterile to SAL 10-6 and are for single use only.

The provided text describes a 510(k) premarket notification for a medical device called DB-Composite Bone Void Filler. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or meeting specific performance criteria through new clinical studies. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, AI performance, ground truth establishment) is not present here.

Instead, the submission focuses on comparing the new device's characteristics and performance to those of a predicate device (Skeletal Kinetics Callos ProModel Bone Void Filler). The "performance testing" section outlines a summary of tests performed on the predicate device (K112383) to demonstrate its safety and effectiveness, and the DB-Composite device is deemed substantially equivalent based on having identical materials, manufacturing processes, and indications for use.

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the DB-Composite device as part of a new study designed to prove its performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device whose performance has already been accepted by the FDA. The performance testing outlined was primarily conducted on the predicate device, and the DB-Composite is considered equivalent due to identical characteristics.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the "test set" or information on data provenance. The performance testing section describes general test methods performed, primarily on the predicate device. It does not refer to a "test set" in the context of clinical or comparative studies on the DB-Composite device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No clinical "test set" requiring expert ground truth is described for the DB-Composite device within this 510(k) summary. The evaluation relies on substantial equivalence to the predicate device and non-clinical performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No clinical "test set" or adjudication method is described.

5. 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

No MRMC study was performed or is relevant here, as this device is a bone void filler, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to AI performance, which is not applicable to this medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests mentioned (e.g., pH profile, FTIR Analysis, Bacterial Endotoxins, etc.), the "ground truth" would be established by the standardized methods and instrument readings defined by the test protocols (e.g., ASTM F1185-03, USP, USP, mineralogic standards). No clinical ground truth (like pathology or outcomes data from new studies) was used for the DB-Composite device, as no new clinical studies were conducted or required.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-Orthopedics Bone Void Filler is a moldable, injectable and biocompatible calcium phosphate bone void filler. The DB-Orthopedics kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only.

The provided text is a 510(k) premarket notification for a medical device called DB-Orthopedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical or AI-assisted setting.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models, are not applicable to this document. This submission is for a material (bone void filler) and relies on physical, chemical, and biocompatibility testing, along with comparison to a predicate device, to demonstrate safety and effectiveness.

However, I can extract information related to the device's technical specifications and the tests performed to support its substantial equivalence, which can be presented in a similar format to what you requested for acceptance criteria and performance data.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Device Performance for DB-Orthopedics (based on provided 510(k) Summary)

This 510(k) submission for DB-Orthopedics focuses on demonstrating substantial equivalence to a predicate device (Callos™ Bone Void Filler, K051123) and expanding the indications for use of a previously cleared device (DB-Cranial Bone Void Filler, K182742). The "acceptance criteria" here refer to meeting established standards and demonstrating similar performance characteristics to the predicate, rather than an AI-driven performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for each test, but standard material testing involves multiple samples to ensure reproducibility and statistical significance.
• Data Provenance: The tests are described as in vitro and ex vivo (simulated physiological conditions). The data would be derived from laboratory experiments conducted by Dimensional Bioceramics, LLC. No country of origin for the specific testing data is mentioned, but the company is based in Santa Cruz, CA, USA.
• Retrospective/Prospective: The testing described appears to be prospective, performed specifically for this 510(k) submission to characterize the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. This submission does not involve an AI diagnostic device requiring expert interpretation of medical images. Ground truth for material characteristics is established through established scientific methods and instrumentation (e.g., ICP-MS for elemental analysis, XRD for crystallography).

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described as it's not a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This is a bone void filler product, not a diagnostic imaging device, so MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was Done

• Not applicable. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

• For the physical and chemical tests, the "ground truth" is based on:
  • Scientific Standards: Adherence to established ASTM or ISO standards (e.g., ASTM F1185-03, ISO 11137-2:2013).
  • Instrumental Analysis: Data directly from scientific instruments (e.g., ICP-MS, FTIR, XRD, SEM).
  • Comparison to Predicate: Performance alignment with the already cleared predicate device (Callos™ Bone Void Filler).
• For biological aspects (biocompatibility, pyrogenicity), the "ground truth" relies on prior successful validation and routine testing, ensuring the material itself does not elicit harmful biological responses.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. The "training" for this device comes from the established knowledge of the materials science for bone void fillers and the manufacturing processes validated through quality systems.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set in the AI sense applies here. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements (e.g., Good Manufacturing Practices, ISO standards). The device is stated to be composed of "identical material" and manufactured by "identical processes" as a previously cleared reference device (DB-Cranial, K182742), indicating that prior validation and historical data serve as the "ground truth" for its production.

Ask a specific question about this device