(268 days)
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations. The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
This document is a 510(k) summary for a medical device called SOFTXIL. It describes that SOFTXIL is a facial silicone implant intended for augmentation or reconstruction of the nasal, malar, and/or chin contour. It is compared to a predicate device, the AART Silicone Carving Block.
Based on the provided text, there is no information about a study that used a test set, ground truth established by experts, or AI performance. The document focuses on non-clinical bench tests and a substantial equivalence discussion to a predicate device.
Here's a breakdown of the available information based on your request, with "Not Provided" for information not found in the text:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Sterilization Validation (ISO11737-1) | Passed (Validation performed) |
| Shelf Life Test (ASTM F 1980): | Passed (Test performed) |
| - Appearance | Passed |
| - Sterility | Passed |
| - Tensile Strength | Passed |
| - Elongation Percentage | Passed |
| - Shore Hardness | Passed |
| - Tearing Strength | Passed |
| - Seal Strength | Passed |
| - Dye Penetration | Passed |
| Biocompatibility Test: | Passed (Tests performed) |
| - ISO 10993-5 (Cytotoxicity) | Passed |
| - ISO 10993-6 (Local Effects After Implantation) | Passed |
| - ISO 10993-10 (Irritation and Skin Sensitization) | Passed |
| - ISO 10993-11 (Systemic Toxicity) | Passed |
| - USP (Antimicrobial Effectiveness) | Passed |
| Performance Tests: | Passed (Tests performed) |
| - Appearance | Passed |
| - Dimensions | Passed |
| - Extractable substances | Passed |
| - Hardness (ASTM F881) | Passed |
| - Tensile Strength (ASTM F881) | Passed |
| - Elongation at Break (ASTM F881) | Passed |
| - Tear Strength (ASTM F881) | Passed |
Note: The document states "The test results of the tests support that the subject device is substantially equivalent to the predicate devices," implying that the device met the acceptance criteria derived from these tests. Specific numerical values for the performance are not provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided (The tests mentioned are non-clinical bench tests, not a clinical test set as typically understood for AI or diagnostic devices.)
- Data Provenance: Not Provided. The applicant is BISTOOL from Seoul, Republic of Korea, where the testing would likely have been conducted, but this is not explicitly stated for all tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Provided (This type of expert evaluation for ground truth is not applicable to the non-clinical bench tests described.)
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided (Not applicable to the non-clinical bench tests described.)
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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 done. This is not a diagnostic device or an AI-assisted device. The document describes a silicone implant and its physical and chemical properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not done. This is not an AI algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical bench tests would be the established scientific and engineering standards and specifications (e.g., ISO, ASTM, USP standards) against which the device's material properties and performance are measured.
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The sample size for the training set
- Not applicable/Not Provided (There is no "training set" as this is not an AI or machine learning device.)
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How the ground truth for the training set was established
- Not applicable/Not Provided (There is no "training set" or corresponding ground truth to establish.)
§ 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.