(49 days)
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer 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-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity. 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 the 510(k) summary for the Nasopore® Ear device, focusing on its substantial equivalence to predicate devices rather than a standalone performance study with specific acceptance criteria and detailed device performance metrics.
Therefore, many of the requested details about acceptance criteria, a specific study proving it, sample sizes, expert involvement, and ground truth establishment are not available in the provided document. The submission relies on demonstrating substantial equivalence based on the device's material composition and intended use being similar to existing cleared devices, rather than an independent performance study with defined acceptance criteria.
Here's a breakdown of what can be gleaned from the text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria for this device | The safety and effectiveness of the Nasopore® were demonstrated via Performance Data: data collected from design verification tests and analyses. |
| In vitro degradation testing | |
| Shelf life testing | |
| Substantial equivalence to predicate devices in terms of physical characteristics and intended use. |
Explanation: The document does not set numerical acceptance criteria for the Nasopore® Ear device's performance in a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices (Invotec Ear Tampon (Wick) w/String and Nasopore® Nasal Dressing). The "performance data" mentioned refers to design verification tests (in vitro degradation and shelf life), which are engineering tests, not clinical performance metrics against specific acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not mentioned. The document does not describe a clinical test set with human or animal subjects for performance evaluation against specific criteria.
- Data Provenance: Not applicable/Not mentioned for a clinical test set. The "performance data" mentioned (in vitro degradation, shelf life testing) would typically be conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not mentioned. No test set requiring expert ground truth is described.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not mentioned. No clinical test set requiring adjudication 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
- MRMC Study: No. This is not an AI-assisted device. The Nasopore® Ear is a physical medical device.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for a typical clinical performance study. The "ground truth" for the claims in this submission is the established safety and effectiveness of the predicate devices and the physical/chemical properties verified by design tests.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not mentioned. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
In summary, the 510(k) submission for Nasopore® Ear relies on a demonstration of "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical performance study with explicit acceptance criteria. The performance data mentioned (in vitro degradation, shelf life) are design verification tests, not clinical performance metrics. The underlying rationale is that if the new device is made of the same material, uses the same manufacturing process, and is intended for a similar use as a previously cleared device, then its safety and effectiveness are considered substantially equivalent.
§ 874.5220 Ear, nose, and throat drug administration device.
(a)
Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.(b)
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 the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.