(53 days)
OtoMimix™ is indicated for the following:
- Augmentation or coupling of the middle ear ossicles.
- Attachment of the middle ear ossicles to middle ear implants.
- Mechanical stabilization of middle ear prostheses
- Reconstruction of the posterior canal wall
OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.
The OtoMimix™ device is a calcium phosphate bone replacement product intended for use in otology procedures for augmentation or coupling of middle ear ossicles, attachment of ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and reconstruction of the posterior canal wall. The provided document does not contain an explicit list of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to previously approved predicate devices to establish its safety and effectiveness.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As there are no explicit quantitative acceptance criteria or detailed performance study results (e.g., success rates, functional outcomes, specific measurements) provided in the summaries for OtoMimix™, a direct table comparing "acceptance criteria" against "reported device performance" cannot be fully constructed in the conventional sense for a performance study.
However, we can infer the "acceptance criteria" from the substantial equivalence comparison to predicate devices, focusing on material composition, indications for use, and critical characteristics. The "reported device performance" in this context is the assertion that OtoMimix™ shares these characteristics with the approved predicates.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicates) | Reported Device "Performance" (Assertion) |
|---|---|
| Material Composition | |
| - Calcium Phosphate Cement | OtoMimix™: Calcium Phosphate cement (Same as Mimix Predicate) |
| Indications for Use | |
| - Augmentation/coupling of middle ear ossicles | OtoMimix™: Indicated for Augmentation or coupling of the middle ear ossicles. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear) |
| - Attachment of middle ear ossicles to implants | OtoMimix™: Indicated for Attachment of the middle ear ossicles to middle ear implants. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear) |
| - Mechanical stabilization of middle ear prostheses | OtoMimix™: Indicated for Mechanical stabilization of middle ear prostheses. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear) |
| - Reconstruction of posterior canal wall | OtoMimix™: Indicated for Reconstruction of the posterior canal wall. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear) |
| Ototoxicity | |
| - Non-ototoxic | OtoMimix™: Demonstrated to be non-ototoxic (Dornhoffer et al.). (Similar to Mimix Predicate, which also demonstrated non-ototoxicity; Oto-Cem had no information but is for otological surgery; Incus Stapes Prosthesis is commonly used for middle ear prostheses.) |
| Sterility | |
| - Provided Sterile | OtoMimix™: Provided Sterile. (Same as all listed predicates) |
| Use | |
| - Single Use | OtoMimix™: Single Use. (Same as all listed predicates) |
| Technological Features | |
| - 2-component cement | OtoMimix™: 2 component cement. (Same as Mimix and Oto-Cem predicates) |
| - Hand Mixed | OtoMimix™: Hand Mixed. (Same as Mimix predicate) |
| - HA material | OtoMimix™: HA material (Calcium Phosphate cement). (Same as Mimix and Incus Stapes Prosthesis predicates) |
| - History of clinical use near dura, CSF | OtoMimix™: History of clinical use near dura, CSF. (Same as Mimix predicate) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of a performance study for OtoMimix™. The device's safety and effectiveness are established through substantial equivalence to predicate devices. This means that instead of conducting a new large-scale clinical trial for OtoMimix™, its characteristics (materials, indications, technological features) were compared to predicates already legally marketed.
The key 'data' supporting equivalence are:
- Material composition: OtoMimix™ uses Calcium Phosphate cement, which is stated to be the "Same as Mimix Predicate."
- Ototoxicity: "Demonstrated to be non-ototoxic (Dornhoffer et al.)" for OtoMimix™, similar to the Mimix predicate. This likely refers to preclinical or clinical data associated with the material class or directly with the Mimix predicate, rather than a specific new study on OtoMimix™ itself in this submission. The origin of this Dornhoffer et al. data (country, retrospective/prospective) is not specified.
Therefore, there is no direct "test set" with a specified sample size or explicit data provenance for OtoMimix™'s performance study within this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there was no independent "test set" requiring expert ground truth establishment for OtoMimix™'s performance study. The evaluation was primarily a comparison of device characteristics against approved predicate devices by the FDA review team.
4. Adjudication method for the test set
Not applicable. There was no "test set" for which adjudication of results would be required. The FDA's review process determines substantial equivalence based on the submitted information and comparison to predicates.
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. This device is a surgical implant/cement, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (bone replacement material), not a software algorithm.
7. The type of ground truth used
The "ground truth" for the substantial equivalence determination relies on:
- Predicate Device Approvals: The regulatory history and approved characteristics of Mimix (K990290, K003494), Oto-Cem (K011338), and Incus Stapes Prosthesis (K861369). These devices already have established safety and effectiveness.
- Material Science/Bench Testing: The assertion that OtoMimix™'s material, technological features, and ototoxicity are "Same as Mimix Predicate," implying that the data (e.g., biocompatiability, mechanical properties, ototoxicity studies like Dornhoffer et al.) associated with the Mimix predicate serve as the basis for OtoMimix™.
- Literature/Expert Consensus: The affirmation that hydroxyapatite is a commonly used material for middle ear prostheses and has an "Extensive history of middle ear use."
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.