(59 days)
Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.
The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.
Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.
The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. The instruments are nonsterile and reusable. They are intended to be cleaned and sterilized before initial use and after each use.
The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic.
This FDA 510(k) clearance letter is for bioabsorbable fixation systems, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. I will provide information from the document as it relates to the general acceptance criteria and the study that proves the device meets them, while noting when a specific AI/ML related field is not relevant to this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance (as per document) |
|---|---|
| Material Composition | Inion CPS™ 1.5/2.0/2.5 System implants: L-lactic acid, D-lactic acid, Trimethylenecarbonate. |
| Inion CPS™ 1.5 Baby System implants: L-lactic acid, D-lactic acid, Poly-Glygolic acid. | |
| Bioresorption Time | Inion CPS™ implants: 2-4 years. |
| Inion CPS™ Baby implants: 2-3 years. | |
| Strength Retention | Inion CPS™ 1.5/2.0/2.5: Retain minimum of 70% of initial strength 9 weeks after implantation. |
| Inion CPS™ Baby 1.5: Retain minimum of 70% of initial strength 6 weeks after implantation. | |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2018 and FDA Guidance. No changes to materials or manufacturing methods. |
| Non-pyrogenicity | Constantly low endotoxin level, below acceptance limit (USP 2011 Chapter ). |
| Passed Rabbit pyrogen tests (ISO 10993-11:2017, Annex G / USP General chapter ). | |
| Clinical Performance | Safe and effective use demonstrated through clinical literature and post-market follow-up data. Performance rate and overall complication rate are within the range of state-of-the-art devices. |
| Sterility | Provided sterile by gamma irradiation. Intended for single use. |
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 Description: Not directly applicable as this is not an AI/ML device with a specific "test set" in the context of algorithm validation. The "testing" refers to various evaluations:
- Biocompatibility/Non-pyrogenicity Testing: Representative samples of the subject devices were selected for rabbit pyrogen tests. The exact number of samples or rabbits is not specified but it generally follows standard laboratory protocols. The provenance is likely from laboratory testing.
- Clinical Evaluation: The clinical evaluation relied on published clinical studies.
- Inion CPS™ Baby 1.5 Bioabsorbable Fixation System: 11 publications including 240 patients.
- Inion CPS™ 1.5/2.0/2.5 System: 39 publications including 1755 patients.
- Data Provenance for Clinical Studies: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond being "published clinical studies."
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 a physical implant, not an AI/ML diagnostic tool that requires experts to establish ground truth for image interpretation or similar tasks. The "ground truth" for its performance is assessed through physical testing (material properties, pyrogenicity) and clinical outcomes reported in published literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, where multiple human experts independently review cases and then resolve disagreements. This concept does not apply to the evaluation of a physical bioabsorbable fixation system.
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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This device is a physical surgical implant and does not involve "human readers" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" (or basis for acceptance) for this device is established through:
- Physical Properties: Material composition, degradation profile, and strength retention are measured against pre-defined specifications.
- Biocompatibility and Non-pyrogenicity: Demonstrated through laboratory testing (e.g., rabbit pyrogen tests) against established biological safety standards (ISO 10993-1, USP chapters).
- Clinical Outcomes Data: Safe and effective use, performance rates, and complication rates are evidenced by published clinical literature and post-market follow-up data.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that requires a training set with established ground truth.
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).