(227 days)
BioSiCar Silicone Implant is intended for the augmentation of the nasal and/or chin contour.
BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
The provided text is a 510(k) Summary for the BioSiCar Silicone Implant. This document describes the device and its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical testing. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
The "acceptance criteria" discussed in the document are general requirements for the device's safety and performance related to its physical and biological properties, not performance metrics for an AI/ML algorithm.
Therefore, I cannot provide accurate answers to most of the requested points, as they pertain to AI/ML device validation studies.
However, I can extract the information that is present:
Metalware Technology Corp. BioSiCar Silicone Implant - 510(k) Summary Analysis
1. A table of acceptance criteria and the reported device performance
The document mentions that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use". However, it does not explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values. It only states that the device "meets the requirements".
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements |
| Performance & Shelf life | Met requirements |
| Sterilization verification | Met requirements |
2. Sample sized used for the test set and the data provenance
Not applicable. The tests performed are non-clinical (e.g., material testing, sterilization, shelf-life), not a clinical study with a "test set" of patient data in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is relevant for AI/ML validation where expert review establishes ground truth for image or data interpretation. The BioSiCar Silicone Implant is a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for AI/ML performance evaluation.
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
No. This device is a physical implant, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical implant.
7. The type of ground truth used
For biocompatibility, performance, and sterilization, the "ground truth" would be established by industry standards (e.g., ISO standards for biocompatibility) and regulatory requirements, rather than expert consensus on medical images or pathology in the context of AI/ML.
8. The sample size for the training set
Not applicable. This is for AI/ML model training.
9. How the ground truth for the training set was established
Not applicable. This is for AI/ML model training.
Summary of what the document does provide:
The document describes the BioSiCar Silicone Implant as "intended for the augmentation or reconstruction of the nasal and/or chin contour." It confirms that "BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use."
It states that non-clinical testing was conducted, including:
- Biocompatibility
- Performance & Shelf life
- Sterilization verification
The conclusion drawn from this non-clinical testing is that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device."
Crucially, "No clinical test data was used to support the decision of substantial equivalence," and the substantial equivalence determination is based on the device having "similar intended use, same technology/mechanism of action, same claim of safety and performance, and similar technological specification as the predicate device, SOFTXIL (K171851)." This implies the acceptance criteria for this type of medical device are primarily focused on material properties, biocompatibility, and manufacturing processes, rather than diagnostic accuracy or clinical outcomes demonstrated in patient studies.
§ 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.