(39 days)
The Hanson Medical Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Calf Implant will be carvable, allowing the physician to customize the device shape for muscular defects.
Hanson Medical Calf Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Calf Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part. liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.
Hanson Calf Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.
The provided text is related to a 510(k) submission for the Hanson Medical Calf Implant. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and clinical efficacy data typically found for diagnostic AI devices.
Therefore, the information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance) is not present in the provided document. The document describes the device, its intended use, and its substantial equivalence to previously marketed devices, but does not detail a study proving its performance against specific acceptance criteria in the manner you've outlined for an AI-enabled device.
To directly answer your specific points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence based on materials, manufacturing methods, and dimensions compared to predicate devices.
- Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an AI performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
- 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-enabled device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-enabled device and no algorithm performance is mentioned.
- The type of ground truth used: Not applicable. The "ground truth" here is the established safety and efficacy of the predicate devices.
- The sample size for the training set: Not applicable. No training set for an AI model is mentioned.
- How the ground truth for the training set was established: Not applicable. No training set for an AI model is mentioned.
Summary based on the document:
The Hanson Medical Calf Implant is presented as substantially equivalent to existing predicate devices (Hanson Medical Silicone Carving Block, AART, Inc and Silimed LLC Calf Implants). The basis for this equivalence is that it employs "the same materials, methods of manufacture, and are identical in dimension and very similar in others." The intended use is for augmentation or reconstruction to minimize muscular defects, and the device is carvable for customization. The regulatory review acknowledges the substantial equivalence to these predicate devices for the specified indications for use.
§ 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.