(410 days)
CureOsTCP is indicated only for filling bone voids or defects that are not intrinsic to the bony structure. CureOs TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, and the pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. CureOs TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
The CureOs TCP is a synthetic resorbable calcium phosphate bone void Filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500pmn. The device is available in a variety of shapes and sizes.
The provided text is a 510(k) summary for a medical device (CureOs TCP, a bone void filler) and does not describe an AI/ML powered device or a study involving human readers or ground truth determination as typically found in such submissions for AI devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of material properties.
Therefore, most of the requested information (acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable or present in this document.
However, I can extract the information that is available regarding the "acceptance criteria" and "study" as presented in this submission, which are related to demonstrating substantial equivalence for a non-AI medical device.
Here's the closest interpretation of your request based on the provided text:
Acceptance Criteria and Study for CureOs TCP (Non-AI Device)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Comparison to Predicate Device: Kasios TCP (K042340)) | Reported Device Performance (CureOs TCP) |
|---|---|
| Material Specifications: | |
| Chemistry substantially equivalent | Chemistry found to be substantially equivalent via FTIR and XRD |
| Crystallinity substantially equivalent | Crystallinity found to be substantially equivalent via XRD |
| Physical form substantially equivalent | Physical form found to be substantially equivalent via SEM |
| Porosity substantially equivalent (60-80% porosity, 200-500µm pore size) | Porosity found to be substantially equivalent via Mercury Intrusion Porosimetry |
| Solubility/Dissolution substantially equivalent | Solubility/Dissolution found to be substantially equivalent |
| Biocompatibility: Meet ISO 10993-1 standards | Met ISO 10993-1 requirements |
| Pyrogenicity (LAL Test): Meet USP 35 NF 30 2012 (85) and European Pharmacopoeia 7th Ed. Vol 1 standards, with no endotoxin at 0.125 EU/ml sensitivity | Met USP 35 NF 30 2012 (85) and European Pharmacopoeia 7th Ed. Vol 1 requirements; no endotoxin observed at 0.125 EU/ml sensitivity |
| Sterilization: Validation in accordance with ISO 11137-2006 to Sterility Assurance Level (SAL) | Validated in accordance with ISO 11137-2006 |
| Risk Management: Identified hazards acceptable/mitigated to acceptable level | Risk management indicates identified hazards were acceptable and/or mitigated to an acceptable level |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as "sample sizes" in the context of a statistical study on a test set. The tests performed ("Chemistry was determined by Fourier Transformed Infrared Spectroscopy (FTIR) and X-ray Diffraction (XRD) techniques. Crystallinity was determined by X-ray Diffraction. Physical form was determined by Scanning Electron Microscopy. Porosity was determined by Mercury Intrusion Porosimetry") imply laboratory testing of the device material itself, likely on representative units.
- Data Provenance: Not specified. The submitter is from Turkey. The tests are general material characterization tests.
- Retrospective/Prospective: Not applicable in this context as it's not a clinical or AI performance study.
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)
- Not applicable. This device is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective material specifications and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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. This is not an AI-powered device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" in this context is established by objective material property measurements, biocompatibility standards (ISO 10993-1), pyrogenicity standards (USP 35 NF 30 2012 (85), European Pharmacopoeia 7th Ed. Vol 1), and sterilization standards (ISO 11137-2006). The equivalence is then assessed against the known specifications of the predicate device.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
§ 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.