(30 days)
Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.
Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.
The provided text is a 510(k) premarket notification for a medical device called "Seare Biomedical Silicone Blocks." This document primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or AI-assisted improvements.
Therefore, many of the requested details about acceptance criteria, study methodology, and AI integration cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The primary criterion is "substantial equivalence in material, function, performance, and design" to predicate devices.
- Reported Device Performance:
- Material: Made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer.
- Function: For carving a finished device by the surgeon for custom use. Designed for carving flatter devices for bone onlay or curved blocks for malar and chin implants.
- Appearance: Clear to slightly opaque. Optionally, pigments (e.g., Iron Oxide) can be added for opacity to light and radiographic exam.
- Sterility: Will be provided sterile.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None. The document explicitly states "Clinical Tests: None." This suggests no formal test set or clinical study was conducted for this premarket notification.
3. 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 applicable. No clinical tests or ground truth establishment based on expert review were conducted or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process was 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
- None. There is no mention of AI assistance or MRMC studies in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a silicone block for implantation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices, not clinical performance data from the device itself.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.