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K Number
K983754
Device Name
STANDARD CHIN
Manufacturer
SURGICAL TECHNOLOGY LABORATORIES, INC.
Date Cleared
1998-11-20

(29 days)

Product Code
FWP
Regulation Number
878.3550
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Surgical Technology Laboratories, Inc. Standard Chin implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for the "Standard Chin" device from 1998. It is a premarket notification for a medical device that determines substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the way a PMA (Premarket Approval) would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or AI performance metrics that you are requesting. This type of information is typically found in clinical study reports, scientific publications, or more recent 510(k) submissions for AI/ML-driven devices.

Here's why your requested information isn't in this document:

  • Device Type: The "Standard Chin" is an implant intended for cosmetic or reconstructive surgery of the mandible. This is a physical, passive medical device, not an AI/ML diagnostic or prognostic tool.
  • Regulatory Pathway (510(k) in 1998): At the time, a 510(k) for devices like this primarily focused on demonstrating that the new device is "substantially equivalent" to a device already on the market (a predicate device). This generally involves comparing materials, design features, and intended use, often supported by bench testing and sometimes limited clinical data to assess safety. It does not typically involve the rigorous performance evaluation studies (like standalone performance or MRMC studies) associated with AI-driven diagnostic tools today.
  • AI/ML was not a factor: Artificial intelligence and machine learning in medical devices were not a significant part of the regulatory landscape in 1998, especially for physical implants.

Therefore, I cannot provide the requested information based on the provided text. The document simply states the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent, allowing it to be marketed.

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.