(98 days)
ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:
- Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
- Mechanical stabilization of middle ear and cochlear implants.
- Attachment of middle ear implants to the ossicular bones.
ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.
Acceptance Criteria and Device Performance for ProCem™ Otologic Bone Cement
This document summarizes the acceptance criteria and supporting study for the ProCem™ Otologic Bone Cement, as derived from the provided 510(k) summary (K140644).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for ProCem™ Otologic Bone Cement are based on its substantial equivalence to predicate devices (SerenoCem, K003567 and EnvoyCem, K080032). The study conducted was primarily to demonstrate that ProCem™ meets physical and functional requirements comparable to these predicate devices.
| Acceptance Criteria | Reported Device Performance (ProCem™) | Reference to Predicate Device |
|---|---|---|
| Exothermic Reaction | Successfully performed and met requirements | Comparable to SerenoCem |
| Working Time | Successfully performed and met requirements | Comparable to SerenoCem |
| Snap Set Time | Successfully performed and met requirements | Comparable to SerenoCem |
| Simulated Preparation Properties | Successfully performed and met requirements | Comparable to SerenoCem |
| Biocompatibility | Demonstrated compliance to biocompatibility testing required for intended use | GIC cements (including predicates) have a long history of safe and effective use |
| Sterility (SAL) | 10-6 SAL achieved via gamma radiation | Packaged in the same manner as predicate devices to assure sterility |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes "Design verification testing" but does not explicitly state specific sample sizes for each test (exothermic reaction, working time, snap set time, simulated preparation properties). The data provenance is not specified in terms of country of origin, but the studies were conducted by Ototronix LLC, the submitter, as part of their 510(k) application. This would be considered a prospective study conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
There is no mention of experts being used to establish a "ground truth" in the context of clinical performance or diagnostic accuracy. The testing described focuses on the physical and functional properties of the bone cement itself, rather than interpretation of clinical outcomes by experts.
4. Adjudication Method for the Test Set
Not applicable. The described testing is focused on objective physical and chemical properties of the device, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is a bone cement, not an imaging or diagnostic AI device that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone study was done. The "Performance Bench Testing" describes in-house design verification testing, demonstrating the physical and functional properties of the ProCem™ device on its own. This testing was performed independent of human interaction in a clinical setting for performance evaluation.
7. Type of Ground Truth Used
The ground truth for the performance bench testing was based on established engineering specifications and comparison to the known performance characteristics of the predicate device (SerenoCem). This involves objective measurements of physical and chemical properties.
8. Sample Size for the Training Set
Not applicable. The ProCem™ Otologic Bone Cement is a physical medical device (bone cement), not a software algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.