(205 days)
total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.
The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes a medical device (Richards Total/Partial Prosthesis) and establishes its substantial equivalence to a predicate device. It does not contain any performance metrics or acceptance criteria as would be found in a study for an AI/software device. It's a 510(k) notification for a physical medical device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to the provided document. The 510(k) notice is for a physical device and doesn't involve a "test set" in the context of AI or software performance evaluation. The device type means there is no data provenance in this case.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. Ground truth for a test set is relevant to AI/software performance, not a physical prosthesis.
4. Adjudication Method for the Test Set
This information is not applicable to the provided document.
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
This information is not applicable to the provided document. An MRMC study is for evaluating AI-assisted workflows in diagnostics, which is not relevant to a physical prosthesis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable to the provided document. "Standalone performance" in this context refers to AI algorithm performance, which is not relevant to a physical prosthesis.
7. The Type of Ground Truth Used
This information is not applicable to the provided document.
8. The Sample Size for the Training Set
This information is not applicable to the provided document. "Training set" is relevant to machine learning, not a physical medical device submission like this one.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to the provided document.
Summary of Document Relevance:
The provided document is a 510(k) premarket notification for a physical medical device, the "Richards Total/Partial Prosthesis." This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device. It highlights the device's materials, indications for use, and design similarities.
The questions you've asked (about acceptance criteria, test sets, experts, MRMC studies, standalone performance, training sets, and ground truth) are highly relevant to the evaluation of AI/software medical devices. They are not applicable to this particular hardware device submission from 1996. The document's purpose is to show that the new device is as safe and effective as existing ones, primarily through material composition and function, rather than through performance metrics derived from a study involving data and algorithms.
{0}------------------------------------------------
JAN 2 2 1997
Food and Drug Administration
510(k) Notification - Richards Total/Partial Prosthesis June 28, 1996
Smith & Nephew ENT
Smith & Nephew Richards Inc.
2925 Appling Rd., Bartlett, TN 38133
Telephone: 901-373-0200
Toll Free: 800-262-3540
Fax: 901-373-0220
510(k) Summary of Safety and Effectiveness
| Trade Name: | Richards Total/Partial Prosthesis |
|---|---|
| Common Name: | Partial Ossicular Replacement Prosthesis |
| Total Ossicular Replacement Prosthesis | |
| Classification Name: | Partial Ossicular Replacement Prosthesis (§ 874.3450) |
| Total Ossicular Replacement Prosthesis (§ 874.3495) | |
| Official Contact: | Ronald K. Smith |
| Senior Regulatory Affairs Specialist | |
| Smith & Nephew ENT | |
| a division of Smith & Nephew Richards, Inc. | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0276 |
| Date Prepared: | June 28, 1996 |
The Richards Total/Partial Prosthesis is substantially equivalent to the Tilt-Top TORP and PORP marketed by Smith & Nephew ENT. These devices have indications for use, total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.
Differences between the Richards Total/Partial Prosthesis and the predicate device should not affect the safety or effectiveness.
Image /page/0/Picture/11 description: The image shows a partial view of a logo or emblem, predominantly in black and white. A bold, sans-serif letter 'R' is prominently featured, partially enclosed within a square or rectangular border. Below the letter, a portion of the word 'RICHARD' is visible, suggesting that the logo is associated with a name or brand. The overall design appears simple and modern.
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.