(92 days)
Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.
OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.
OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation.
OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.
The provided text describes the OsteoVation Impact, a calcium phosphate bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device (OsteoVation® CMF Bone Void Filler, K051784) rather than establishing novel acceptance criteria for a new type of device. Therefore, the "acceptance criteria" discussed here relate to ensuring the modified device maintains performance comparable to the predicate.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format with specific numerical targets for each test, but it describes how results were evaluated against the predicate device. The performance is consistently stated as "comparable to the predicate device" or "PASS," implying that the results fell within acceptable ranges established by the predicate's performance.
| Test | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Working time | Tests performed to determine the workability time of the cement, including mixing and molding of the paste. | Comparable to the predicate device. | All samples passed the targeted working time and setting strength. The test results demonstrated working time comparable to the predicate device. |
| Setting Time | Testing conducted to determine the Setting strength (Mean ≥ 450N and ≥ 700N) at various time points in a target temperature solution, post-sterilization after a target working time. | Mean ≥ 450N and ≥ 700N; Comparable to the predicate device. | All samples passed the targeted setting time. The test results demonstrated setting time comparable to the predicate device. |
| Tensile Strength | Evaluated subject device minimum tensile strength at 24 hours. Samples prepared through mortal/pestle combination into molds in varying diameters and thickness, placed in a prepared solution at 37°C for 24 hours. Tested using a mechanical testing system. | Comparable to the predicate device. | PASS. The test results demonstrated tensile strength comparable to the predicate device. |
| Temperature Profile | Subject device mixed and placed into a centrifuge tube and into a 37°C water bath. Temperature profile recorded at specified intervals using a computer controlled thermocouple for 24 hours. | Comparable to the predicate device. | PASS. The test results demonstrated temperature profile comparable to the predicate device. |
| pH Profile | Subject device mixed and placed into a centrifuge tube and into a 37°C water bath. pH recorded at specified intervals using a calibrated probe with a TC temperature compensator. Evaluates physiological characteristics. | Comparable to the predicate device. | PASS. The test results demonstrated pH profile comparable to the predicate device. |
| FTIR Analysis | Mix and incubate subject device for 24 hours. Dry cured sample at 37°C for 72 hours. Perform 64 scans at typical resolution of 4cm-1. Determines the formation of hydroxyapatite. | Nearly identical hydroxyapatite structure as the predicate device. | PASS. FTIR analysis show nearly identical hydroxyapatite structure as the predicate device. |
| Crystallographic Analysis | Analyze prepared sample using x-ray diffractometer (XRD). Perform Rietveld analysis to determine ratios of each compound in cured cement. | Comparable results as the predicate device. | PASS. XRD analysis show comparable results as the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes (number of devices, batches, or specimens) used for each bench test. It mentions "All samples" passed for working and setting time but doesn't quantify "all."
The data provenance is bench testing conducted by Skeletal Kinetics, LLC. There's no mention of country of origin for data as it's mechanical/chemical testing. The tests are prospective for the modified device to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
N/A. This being a bench test study for a material, there isn't a "ground truth" established by experts in the typical sense (e.g., radiologist consensus for image analysis). The "ground truth" is derived from the objective physical and chemical properties and performance of the device and its comparison to a well-characterized predicate.
4. Adjudication Method for the Test Set:
N/A. This is not applicable to bench testing of material properties. The results are physical measurements and chemical analyses, not subjective assessments requiring adjudication.
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:
N/A. This study is for a medical device (bone void filler material), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. As above, this is about a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this submission is the established performance characteristics and material composition of the predicate device (OsteoVation® CMF Bone Void Filler, K051784). The goal of the study was to demonstrate that the modified OsteoVation Impact has comparable physical, chemical, and performance characteristics to this predicate, ensuring that the formulation change did not adversely affect its safety and efficacy.
8. The sample size for the training set:
N/A. This is not a machine learning or AI study, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
N/A. There is no training set in this context.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).