(90 days)
The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure.
The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants.
Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.
The provided document, K97223/7, is a 510(k) summary for the Montgomery® Thyroplasty Implant System. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. The section on "CLINICAL STUDIES" briefly mentions a clinical study, but it does not provide detailed acceptance criteria or a comprehensive report of device performance against specific metrics.
Here's an analysis of the information available and what is missing based on your requested format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: Low number of complications | "low number of complications" |
| Effectiveness: Improvement of voice quality | "improvement of voice quality, as demonstrated by responses to the patient survey, acoustic analysis, and stroboscopy." |
Missing Information:
- Specific numerical targets or thresholds for "low number of complications" (e.g., complication rate
§ 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.