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510(k) Data Aggregation
(54 days)
NASOPORE EAR
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.
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(49 days)
NASOPORE EAR, MODELS ND04, ND05
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.
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