(54 days)
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.
Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.
The provided text describes a 510(k) premarket notification for the Nasopore® Ear device and focuses on its substantial equivalence to predicate devices rather than a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not explicitly present in the provided document.
However, based on the spirit of the request and what is available, here's a structured interpretation:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative "acceptance criteria" in the way one might expect for a diagnostic AI device (e.g., target sensitivity/specificity). Instead, the "performance" verification focuses on design characteristics demonstrating safety and equivalence.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance (as demonstrated by design verification tests and analyses) |
|---|---|
| Material Degradation: Device fragments and is bioresorbable. | In-vitro Degradation Testing: Performed to demonstrate the material fragments and bioresorbable nature within several days after insertion. (Specific data not provided) |
| Shelf Life: Device maintains its properties over its stated shelf life. | Shelf Life Testing: Performed to confirm the device's stability over time. (Specific data not provided) |
| Biocompatibility: Device material is safe for use in the body. | Biocompatibility: Demonstrated by the fact that the material (poly(DL-lactide-co-s-caprolactone) urethane) is the same as the predicate Nasopore® Nasal Dressing (K052099), which has demonstrated satisfactory biocompatibility. |
| Functional Equivalence (Physical Characteristics): Similar physical properties to predicate. | Physical Characteristics: Stated to be equivalent to Nasopore® Nasal Dressing, as it's made from the same material and uses an identical manufacturing process. |
| Functional Equivalence (Intended Use): Performs similarly to predicate for its indicated use. | Intended Use: Stated to be substantially equivalent to Nasopore® Nasal Dressing for use as a space-occupying stent, preventing adhesions, and controlling minimal bleeding, differing only in anatomical location (outer/middle ear vs. nasal/sinus cavities). Also equivalent to Invotec Ear Tampon for its primary function. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as no "test set" in the sense of patient data for evaluating diagnostic performance (like an AI model) was used. The evaluation was based on design verification tests (in-vitro) and comparison to a predicate device.
- Data Provenance: The data primarily relates to in-vitro testing and manufacturing process descriptions. There is no mention of country of origin for patient data or whether it was retrospective or prospective, as no clinical study focused on patient outcomes was presented for this device. The biocompatibility claim relies on prior approval of the predicate device (Nasopore® Nasal Dressing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by medical experts for a diagnostic performance test set is described.
4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process is described.
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 medical implant (ear packing) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant and not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and efficacy of the predicate devices. For biocompatibility, the ground truth is the previous determination of "satisfactory biocompatible" for the poly(DL-lactide-co-s-caprolactone) urethane material used in the Nasopore® Nasal Dressing. For functional aspects, the ground truth is the known performance and indications for use of the predicate devices (Nasopore® Nasal Dressing and Invotec Ear Tampon).
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.