(159 days)
DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.
DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.
The provided text is a 510(k) summary for the DSM Biomedical Calcium Phosphate Cement. It states that the device is substantially equivalent to a predicate device based on various criteria, including performance data. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria, specific reported device performance values, sample sizes for test or training sets, expert qualifications, or adjudication methods for studies.
The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker® Injectable Cement K060061) through comparisons of:
- Indications for Use
- Material Composition
- Technological Characteristics
- Performance Characteristics
It mentions that "material characterization, including chemical and material physical characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety." It also states these were completed in accordance with FDA Guidance Document, "Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants."
An "ovine bilateral femoral defect animal study" was performed to evaluate bone healing.
Therefore, many of the specific details requested cannot be extracted from this document.
However, I can provide a summary of what is mentioned concerning performance and the basis for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and corresponding reported device performance values. It states that tests were conducted according to FDA guidance and ASTM standards, implying that the device met the requirements of those standards.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for any of the tests.
- Data Provenance: The animal study was an "ovine bilateral femoral defect animal study." This suggests an animal model study, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is related to a medical image analysis or diagnostic device, which this bone void filler is not. The ground truth for performance would be based on the physical, chemical, and biological measurements from the lab and animal studies.
4. Adjudication method for the test set
Not applicable for this type of device and study.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/imaging device.
7. The type of ground truth used
For the performance of the material:
- Physical and chemical characterization data (e.g., setting time, mechanical strength, composition, resorption rate – though specific values are not listed).
- Biocompatibility test results (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute toxicity, implantation).
- Viral inactivation study results.
- Residual chemical assessment results.
- Bone healing evaluation from the ovine animal study (comparison to predicate).
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
Summary of Device Performance (as described in the document, without specific values):
| Characteristic | DSM Biomedical Calcium Phosphate Cement (Proposed) | Assessment in Document |
|---|---|---|
| Material Characterization | Calcium phosphate powder with bovine collagen | Completed in accordance with FDA Guidance and ASTM F1185. |
| Physical Characteristics | Injectable, sculptable, fast setting, converts to hydroxyapatite | Compared to predicate device, deemed similar. |
| Biocompatibility | Biocompatible | Testing completed per ISO 10993-1. Results indicate acceptable biocompatibility. |
| Viral Inactivation | Conducted | Study performed. |
| Animal Study | Bone healing | Evaluated bone healing in an ovine bilateral femoral defect model compared to the predicate device. |
| Sterilization | Sterile, SAL 10-6 | Confirmed (stated in table). |
| Reusable | Single Use Device | Confirmed (stated in table). |
The document concludes that "The bench, animal, and biocompatibility testing demonstrates that DSM Biomedical Calcium Phosphate Cement is substantially equivalent to the predicate device." This implies that the device met the performance requirements necessary to establish substantial equivalence based on the completed tests.
§ 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.