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510(k) Data Aggregation
(265 days)
DB-CMF
DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial 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-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.
The document provided is a 510(k) summary for the DB-Cranial device. It describes various performance tests conducted to demonstrate substantial equivalence to a predicate device, OsteoVation® Impact (K162864).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Important Note: This document does not describe a study that uses AI or machine learning. It is a submission for a medical device (a calcium phosphate bone void filler) that undergoes physical and chemical performance testing to demonstrate substantial equivalence. Therefore, many of the requested bullet points regarding AI/ML studies (e.g., sample size for test set, data provenance, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for DB-Cranial were established by comparing its performance to that of the predicate device, OsteoVation® Impact (K162864). The "Results" column essentially serves as the reported device performance and also confirms that the device meets the implied acceptance criteria of being substantially equivalent to the predicate.
| Test | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance and Substantial Equivalence |
|---|---|---|---|
| Working Time In-Vitro | Ensures sufficient manipulation time and setting strengths. Mixing, mold-ability, and setting strengths were measured. | Sufficient indentation loads to ensure targeted working time and setting strength. | Both subject and predicate device reached sufficient indentation loads to ensure targeted working time and setting strength. |
| Setting Time | Setting tests determined strength (Mean $\geq$ 450N and $\geq$ 700N) at specified time points post sterilization and post mixing. | Similar setting strengths to predicate at all time points. Strength values substantially equivalent. | Subject and predicate devices achieved similar setting strengths at all time points. Strength values of these two setting cements are substantially equivalent. |
| Ca to P Ratio | This test determines CA/P ratios via ICP-MS. | Ca/P ratio of 1.5, identical to the predicate device. | Both samples have a Ca/P ratio of 1.5. This test confirms both subject and predicate are composed of identical amounts of calcium and phosphate salts. |
| Kit Components | Kit ingredients are compared to determine substantial equivalence. | Consist of alpha-tricalcium phosphate (Powder) and sodium silicate-sodium phosphate solution (Liquid), identical to the predicate. | Both subject and predicate device consist of alpha-tricalcium phosphate (Powder) and sodium silicate-sodium phosphate solution (Liquid). |
| Heavy Metal Analysis | Samples are analyzed for trace heavy metal content using ICP-MS. | Trace metal limits below allowable limits. | Trace metal limits were below allowable limits in both subject and predicate. |
| pH Profile | Examines effects of the device on pH surrounding the implanted device. pH is measured in physiologic buffer solutions surrounding curing cements. | All pH readings remained within normal physiological range. | All pH readings remained within normal physiological range for both predicate and subject devices. |
| FTIR Analysis | Identifies the chemical composition following curing in simulated physiologic conditions. | Both subject and predicate device show the formation of hydroxyapatite. Substantially equivalent. | Both subject and predicate device both show the formation of hydroxyapatite. Subject and predicate device are substantially equivalent with regards to FTIR chemical analysis. |
| Crystallographic Analysis | XRD analysis with samples set in simulated physiologic conditions for 2 hours, 1 day, 3 days, and 7 days. Compared against known mineralogic standards. | Confirmed identical crystallographic analysis to predicate over several clinically relevant time points. | Both subject and predicate device are confirmed identical via crystallographic analysis. The same crystalline structure over several different clinically relevant time points is formed in both materials. |
| Temperature Profile | Device samples tested in simulated physiologic solutions to measure temperature of curing cement at 2-minute intervals over 20 minutes. | Set in an isothermic manner with minimal risk of thermal necrosis. Substantially equivalent. | Both subject and predicate device set in an isothermic manner as designed. This demonstrates a minimal risk of thermal necrosis of tissue surrounding the implantation site. In this respect, both subject and predicate device are substantially equivalent. |
| Solubility and Dissolution | Test samples cured and incubated at simulated physiological conditions for 4 days; fluid extracted and tested for Ca2+ concentration via ICP-AES. | Substantially equivalent solubility and dissolution to predicate. | Both subject and predicate device have substantially equivalent solubility and dissolution. |
| Tensile Testing | Test samples mixed and cured for 24 hours at simulated temperature and pH. Tensile testing performed using a mechanical tester. | Identical tensile strength at 24 hours to predicate. Substantially equivalent. | Subject and predicate device demonstrated identical tensile strength at 24 hours and are substantially equivalent in terms of tensile strength. |
| Dimensional Stability | Dimensional stability measured to establish that the bone void fillers maintain shape and do not dissolve in an untimely manner. | Dimensionally stable with no discernable differences from predicate. | Subject and predicate are dimensionally stable materials with no discernable differences in form. |
| Physical Form | Test samples imaged by SEM to determine microstructural similarities and differences. | Demonstrated hydroxyapatite crystal formation identical to predicate. | Both subject and predicate device demonstrated hydroxyapatite crystal formation. Subject and predicate device set to form hydroxyapatite in an identical manner. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify the exact number of samples used for each test (e.g., number of specimens for tensile testing, number of batches for chemical analysis). The tests are typically conducted on a sufficient number of samples to ensure statistically sound results for material characterization.
- Data Provenance: The data provenance is generally from laboratory bench testing (in vitro simulations). The country of origin of the data is not explicitly stated, but it would typically be where the manufacturer (Dimensional Bioceramics, LLC, Santa Cruz, CA) or their contracted laboratories are located. The testing is prospective for the device being submitted, although it involves comparison to an already marketed predicate.
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)
This is not applicable as the study involves physical and chemical property testing of a biomaterial, not subjective interpretation by medical experts. The "ground truth" for these tests comes from established scientific and engineering principles (e.g., ASTM/ISO standards for material testing, analytical chemistry techniques).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no subjective adjudication required for quantitative and qualitative material property tests.
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
Not applicable. This is not an AI/ML-driven diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests is derived from:
- Established material science and engineering principles.
- Quantitative measurements made by validated analytical equipment (e.g., ICP-MS, XRD, mechanical testers).
- Qualitative observations based on scientific methodologies (e.g., FTIR, SEM).
- The performance of the legally marketed predicate device, used as a benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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