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510(k) Data Aggregation
(60 days)
The ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStent is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
NasaStent is a dissolvable polysaccharide intranasal splint made from plant-based CarboxyMethyl Cellulose (CMC). As it absorbs nasal fluids, it turns into a hydrocolloidal gel that naturally drains from the nasal cavity within several days.
The ArthroCare NasaStent™ CMC Nasal Dressing is a Class I device, and its 510(k) submission (K140992) indicates that no clinical studies were necessary to demonstrate its safety and effectiveness. Instead, the submission relies on bench testing to establish substantial equivalence to predicate devices.
Here's an analysis based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalency through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (conformance to ISO 10993-1) | Biocompatibility testing according to ISO 10993-1 was conducted. (Assumed to have met acceptance criteria, though no specific results are provided). |
| Packaging Validation | Packaging validation was conducted. (Assumed to have met acceptance criteria). |
| Equivalency in Resiliency to Predicate Devices | Equivalency testing with respect to resiliency was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Hygroscopic Characteristics to Predicate Devices | Equivalency testing with respect to hygroscopic characteristics was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Form Retention to Predicate Devices | Equivalency testing with respect to form retention was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Conformance to design specifications | Evaluated under a number of bench studies to assure safety, efficacy, and conformance to design specifications. (Implied that the device conformed to design specifications). |
| Substantial Equivalence to Predicate Devices (CogENT, NexPak, Nasopore) in terms of indications for use, device operation, technical and functional capabilities, design, principle of operation, and raising no new questions of safety or effectiveness. | "NasaStent shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use. Additionally, comparative performance test data demonstrated adequate device performance." |
| "NasaStent is substantially equivalent to the predicate CogENT, NexPak, and Nasopore nasal splints in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness." |
2. Sample Size and Data Provenance (Test Set)
No clinical test set was used for this 510(k) submission. The evaluation was based entirely on bench testing. Therefore, there is no information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective).
3. Number of Experts and Qualifications (Ground Truth for Test Set)
Not applicable as no clinical test set requiring expert ground truth was utilized.
4. Adjudication Method (Test Set)
Not applicable as no clinical test set was utilized.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The product is a physical device (intranasal splint), not an AI algorithm, and therefore the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used (for studies that were performed)
For the bench tests that were performed, the "ground truth" would be established by validated engineering specifications, industry standards (e.g., ISO 10993-1), and comparative performance against the established characteristics of the predicate devices. The document implies that the device met these engineering and performance benchmarks.
8. Sample Size for the Training Set
Not applicable. As a physical device evaluated via bench testing, there is no "training set" in the context of an algorithm. The "training" for the device would have been its design and manufacturing processes, which are not detailed in terms of sample sizes for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the algorithmic sense. The design and manufacturing would be based on established engineering principles and medical needs for intranasal splints.
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(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.
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