(42 days)
The intended use of the AART Silicone Carving Block is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. The rectangular blocks are designed for carving flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.
The AART Silicone Carving Blocks are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or rectangular shapes. They are provided in seven styles with dimensions varying in length, width, height and initial shape. Pigments may be added to the silicone to make the blocks opaque if requested by the physician. The AART Silicone Carving Block is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.
This submission for the AART Silicone Carving Block is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way one might for an AI/ML or diagnostic device. As such, the typical structure for reporting acceptance criteria and study data does not directly apply here.
The "study" in this context is the comparison made to predicate devices to establish substantial equivalence based on material, design, function, and performance, not a clinical trial with statistical endpoints.
Here's a breakdown of the information as it relates to this 510(k) submission, with an explanation of why some sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Material: Medical grade silicone elastomer | Manufactured from medical grade silicone elastomer |
| Design: Various convex oval or rectangular shapes | Provided in seven styles with varying dimensions |
| Function: Used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary; carving flatter devices for bone onlay; carving curved devices for nasals, malars, or body contouring | Intended for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary; rectangular blocks for bone onlay; contoured blocks for carving curved devices (nasals, malars) or body contouring |
| Performance: Safe and effective for intended use | Equivalent to predicate devices which are safe and effective |
Explanation: The "acceptance criteria" for a 510(k) are implicitly the characteristics of the predicate devices. The "reported device performance" is the manufacturer's assertion that their device meets these characteristics, thereby demonstrating substantial equivalence. There are no explicit quantitative performance metrics or acceptance thresholds in this document because it's a materials/design equivalence submission.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. There was no specific "test set" in the sense of patient data or clinical samples for a performance study.
- Data Provenance: Not applicable. The "data" here refers to the characteristics of the predicate devices and the new device. The provenance is from the manufacturing specifications and regulatory history of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "ground truth" to be established by experts in the context of a performance study. The ground truth, here, is the established safety and effectiveness of the predicate devices, which is generally accepted by regulatory bodies.
4. Adjudication method for the test set
- Not applicable. No adjudications by experts were performed as part of a performance study.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device, and no standalone algorithm performance was assessed.
7. The type of ground truth used
- Not applicable in the typical sense of a diagnostic or AI device study. The "ground truth" implicitly relies on the established safety and efficacy of the predicate devices based on their historical use and regulatory clearances. This is a "comparison to predicate" ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
Summary of the "Study" (Substantial Equivalence Justification):
The "study" in this 510(k) submission is a declaration and demonstration of substantial equivalence to existing, legally marketed predicate devices. The manufacturer, Aesthetic and Reconstructive Technologies, Inc. (AART), argued that their Silicone Carving Block is substantially equivalent to:
- Silicone Carving Block marketed by Hanson Medical, Inc.
- Spectrum Designs Pre-Form Contour Silicone Carving Block marketed by Spectrum Designs, Inc.
The basis for this substantial equivalence claim rests on the following points:
- Identical Intended Uses: The AART device shares the same intended use for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary, and specific uses for rectangular and contoured blocks, as the predicate devices.
- Similar Materials: The device is manufactured from a medical grade silicone elastomer, which is presented as equivalent to the materials of the predicate devices.
- Similar Design and Performance: The devices are offered in similar shapes and sizes (various convex oval or rectangular shapes, seven styles) and are expected to perform comparably to the predicate devices.
The FDA reviewed this comparison and, finding the claims of equivalence sufficient, issued a determination of substantial equivalence, allowing the device to be marketed. No new clinical or performance data from a specific study with defined acceptance criteria were required or presented beyond the comparative analysis to the predicate devices.
§ 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.