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K Number
K973567
Device Name
SOWELL COBALT-CHROME METAL ALLOY
Manufacturer
C.K. INTERNATIONAL TRADING
Date Cleared
1997-12-11

(83 days)

Product Code
EJH
Regulation Number
872.3710
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOR PARTIALS, STAYPLATES, CLASPS AND REST ON MISSIAL OR DISTAL.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Sowell Cobalt-Chrome Metal Alloy." This type of letter generally does not include detailed study information, acceptance criteria, or performance data in the way a clinical study report or a premarket approval (PMA) application summary would.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving device performance.

Here's why the prompt cannot be answered from the provided text:

  • No Acceptance Criteria: The letter does not define any specific performance metrics or thresholds for the device.
  • No Study Details: There is no mention of a study design, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
  • No Reported Performance: The letter only grants clearance based on substantial equivalence; it does not report any performance statistics for the device itself.
  • No AI Component: This device is a metal alloy, not an AI/ML-driven software device. Therefore, questions regarding MRMC studies, standalone algorithm performance, or human improvement with AI assistance are not applicable.

In summary, the provided document does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found for AI/ML medical devices or devices requiring extensive performance data.

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.