(30 days)
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
| Test/Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Working Time (In Vitro) | Sufficient manipulation time for operative theater, meeting cement setting-times. | Ensures sufficient manipulation time is provided while also ensuring cement setting-times are met in the operative theater. (Performance aligns with criteria) |
| Setting Time | Bone void filler sets within simulated physiological conditions. | Measures the time for bone void filler to set in simulated physiologic conditions. (Performance measurement aligns with criteria) |
| Ca to P Ratio | Consistent and appropriate Calcium to Phosphorus ratio (e.g., similar to predicate/HA). | DB-Orthopedics has a ratio of 1.5. (Specific ratio reported) |
| Heavy Metal Analysis | Below trace limits as per ASTM F1185-03. | Samples analyzed for trace heavy metal content using ICP-MS, according to ASTM F1185-03. (Compliance with standard implied) |
| pH Profile | Minimal or acceptable effect on pH surrounding the implanted device. | Examines effects of the device on pH surrounding the implanted device. pH is measured in physiologic buffer solutions surrounding curing cements. (Test performed) |
| FTIR Analysis | Chemical composition similar to predicate device after curing. | Identifies the chemical composition of subject and predicate device following curing in simulated physiologic conditions. (Comparison performed) |
| Crystallographic Analysis (XRD) | Formation of expected crystalline structure (e.g., hydroxyapatite). | XRD analysis performed with samples set in simulated physiologic conditions, evaluated using powder x-ray diffraction and compared against known mineralogic standards. (Test performed, hydroxyapatite crystal formation confirmed under "Physical Form") |
| Temperature Profile | Acceptable temperature rise during curing. | Device samples tested in simulated physiologic solutions to measure temperature of curing cement. (Test performed) |
| Solubility and Dissolution | Acceptable solubility and dissolution rate to allow for bone replacement. | Test samples are cured and incubated at simulated physiological conditions for a specified time and measured for solubility and dissolution. (Test performed) |
| Tensile Testing | Acceptable mechanical strength, comparable to predicate. | Test samples mixed and cured for 24 hours at simulated temperature and pH. Tensile testing performed, load at breakage recorded and compared. (Test performed) |
| Dimensional Stability | Maintains shape and does not dissolve in an untimely manner. | Dimensional stability measured to establish that bone void fillers maintain shape and do not dissolve in an untimely manner. (Test performed) |
| Physical Form | Exhibits expected microstructure (e.g., hydroxyapatite crystal formation). | Test samples imaged by SEM to determine microstructure. Testing confirmed hydroxyapatite crystal formation. (Confirmed) |
| Biocompatibility | Biocompatible, no adverse biological reactions. | No biocompatibility studies needed as no changes from original submission were made and substantial equivalence demonstrated. (Relies on prior clearance) |
| Pyrogenicity | Non-pyrogenic. | Pyrogenicity (LAL) testing routinely performed on the product. (Routinely confirmed) |
| Sterilization and Shelf Life | Sterile (SAL of 10^-6) and stable for stated shelf life. | Sterilization method is gamma radiation (ISO 11137-2:2013 VDMax25). Labeled with a shelf life of 30 months. (Validation performed/stated) |
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.
§ 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.