(143 days)
Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.
The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
This document is a 510(k) summary for the Pillar Nasal Implant, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the information requested in your prompt is not available in these documents.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Silimed, Inc Elifal nasal implant).
The "performance" reported is primarily related to physical and chemical properties and intended use, aligning with the predicate device:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition | Identical liquid elastomer materials (Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc.) as the predicate device. |
| Manufacturing Process | Identical manufacturing processes as the predicate device. |
| Durometer (Hardness) | Ranges from 5 to 30 Shore A (consistent with predicate). |
| Appearance | Clear to opaque (consistent with predicate). |
| Tensile Strength | Averages 700 psi (consistent with predicate). |
| Elongation | Over 400 percent (consistent with predicate). |
| Intended Use | To augment or reconstruct facial nasal deformities caused by facial trauma or congenital defects (identical to predicate). |
| Surgical Methods | Implanted using the same accepted surgical methods of the predicate device. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence based on material, manufacturing, and intended use comparison to a legally marketed predicate device. It does not involve a "test set" of patient data in the way an AI/ML device would. No clinical study data is presented to prove performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As above, there is no "test set" or "ground truth" establishment in the context of clinical performance evaluation for this 510(k) submission.
4. Adjudication method for the test set:
- Not applicable.
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 physical implant, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- Not applicable. The "ground truth" for this submission would primarily be the established physical, chemical, and functional characteristics of the predicate device and the demonstration that the Pillar Nasal Implant matches these characteristics.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.