(74 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 from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The 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.
The DSM Calcium Phosphate Cement is a line extension to the current DSM Calcium Phosphate Cement product line, which introduces the 1cc size and a new packaging configuration. DSM Calcium Phosphate Cement is an injectable, sculptable, drillable, fast self-setting bone substitute. DSM 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 and is packaged in a female luer syringe. An empty male luer syringe is provided to allow for syringe-to-syringe mixing of the powder with saline at the required powder-to-liquid ratio. DSM Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.
This document is a 510(k) premarket notification for the DSM Biomedical Calcium Phosphate Cement. It describes a line extension of an existing product, specifically a new 1cc size and packaging configuration. The submission aims to demonstrate substantial equivalence to the predicate device (DSM Biomedical Calcium Phosphate Cement, K173362).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Subject Device (1cc DSM Biomedical Calcium Phosphate Cement) Reported Performance | Predicate Device (DSM Biomedical Calcium Phosphate Cement, K173362) |
|---|---|---|
| Indications for Use | To fill bony voids or gaps of the skeletal system (extremities and pelvis), surgically created or from traumatic injury. Not for intrinsic stability. Augments provisional hardware. Temporary support, resorbs and replaced by bone. | Identical Indications for Use |
| Material Composition | Calcium phosphate powder with bovine collagen mixed with saline to form hydroxyapatite | Calcium phosphate powder with bovine collagen mixed with saline, patient's blood, or patient's bone marrow aspirate to form hydroxyapatite |
| Form | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite |
| Packaging | Powder pre-packaged in a female luer syringe, packaged with accessories to aid in mixing and delivery. | Powder prepackaged in a mixing and delivery syringe, packaged with accessories to aid in mixing and delivery. |
| Sterilization | Sterile by gamma irradiation (validated per ISO 11137-1 and ISO 11137-2). | Sterile by gamma irradiation |
| Reusable | Single Use Device | Single Use Device |
| Biocompatible | Yes (acceptance based on ISO 10993-1, -3, -5, -10, -11, -17, ISO 22442-2, -3, USP) | Yes |
| Sizes Offered | 1cc | 5cc |
| Shelf Life | Confirmed by stability testing | Not specified in table, but generally implied for predicate. |
| Product Appearance | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Handling | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Injectability | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Setting Time | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Compressive Strength | Met | Not explicitly stated, implied to be acceptable for predicate. |
| X-ray Diffraction | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Porosity | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Anchor Pull Out Strength | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Bacterial Endotoxins (BET) | Not more than 20 Endotoxin Units per device (met specifications per USP and AAMI ANSI ST72: 2019) | Not explicitly stated, implied to be acceptable for predicate. |
| Packaging Integrity | Met requirements of ISO 11607-1 | Not explicitly stated, implied to be acceptable for predicate. |
| New Bone Formation (animal study at 12 weeks) | 5.8% ± 2% | 6.3% ± 3.2% |
| Implant Material Remaining (animal study at 12 weeks) | 84.2% | 86.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Bench Testing (Material, Mechanical, Physical): The document does not specify the exact sample sizes for each type of bench testing (e.g., injectability, setting time, compressive strength). It just states that "Material characterization and performance testing... was completed." The provenance is likely internal testing by DSM Biomedical.
- Biocompatibility Testing: The number of samples for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Subacute Systemic Toxicity, Pyrogenicity) is not specified. Provenance is likely contract labs performing testing according to ISO 10993 standards.
- Performance Animal Testing: The test set used an "ovine critical sized femoral defect model." The number of animals in the DSM + saline group and the Hydroset predicate group is not explicitly stated, but the percentages imply multiple subjects, and statistical variations (e.g., "± 2%") would necessitate a reasonable sample size for statistical significance. This appears to be a prospective animal study specifically designed for this submission or product line.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: Ground truth for bench testing is established by recognized standards (FDA Guidance Document, ASTM F1185, USP , AAMI ANSI ST72: 2019, ISO 11607-1, ISO 11137-1/2, ISO 10993 series, ISO 22442-2/3). Experts are likely engineers and scientists within DSM Biomedical or independent testing laboratories with expertise in these standards. Their specific number and qualifications are not detailed.
- Animal Study: The animal study compared the device to a predicate and an empty defect control. The "ground truth" here is the biological response (new bone formation, implant remaining) observed in the ovine model. The evaluation of these outcomes would typically involve veterinary pathologists and/or histologists; however, their specific number and qualifications are not mentioned.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for human reviewers in a clinical context. The "adjudication" for bench and animal testing is inherent in the standardized methodologies and objective measurements.
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 comparative effectiveness study was mentioned. This device is a bone void filler, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is irrelevant for the DSM Biomedical Calcium Phosphate Cement, as it is a medical device material/implant and not an algorithm or AI product.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth established through objective measurements against pre-defined performance specifications derived from recognized standards (ASTM, ISO, USP, FDA guidance).
- Biocompatibility Testing: Ground truth established through biological response assays compared against established criteria for acceptable biocompatibility (based on ISO 10993 series).
- Animal Study: Ground truth for "performance" (new bone formation, implant remaining) was established by histological and quantitative analysis of tissue samples from the ovine femoral defect model.
8. The Sample Size for the Training Set
This product is not an AI/ML algorithm requiring a training set. This question is not applicable.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 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.