(77 days)
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.
This 510(k) summary for the Aesculap Titanium Alloy Bone Screws does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML or diagnostic performance.
The document describes a medical device, specifically bone screws, and focuses on its substantial equivalence to previously marketed devices. The "Performance Data" section explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium alloy screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards."
This indicates that the performance data described here is related to mechanical testing (fatigue testing) of the physical screws, not a study evaluating diagnostic performance, AI algorithm performance, or human reader improvement with AI assistance.
Therefore, I cannot provide the requested table and details because the provided text does not describe:
- Acceptance criteria related to AI/ML performance.
- A study proving diagnostic or AI/ML performance.
- Details about sample sizes for test/training sets, experts, or ground truth relevant to AI/ML or diagnostic studies.
- Information about MRMC studies or standalone algorithm performance.
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CULAP. K970549
510(k) Summary of Safety and Effectiveness (in Accordance with SMDA of 1990)
APR 30 1997
Aesculap Titanium Alloy Bone Screws
Submitted by:
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
Contact: Victoria Mackinnon Phone: (415) 876-7000 x346 (415) 589-3007 FAX:
Product Name
Trade Name: Bone Screws Common Name Classification Name:
Aesculap Titanium Alloy Bone Screws Screw, Fixation, Bone
Predicate Device
The titanium allov bone screws from Aesculap are identified as predicate devices.
Device Description
The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.
Intended Use
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
Summary of Technological Characteristics
Aesculap's Titanium Alloy Bone Screws represent no change in technological characteristics. There have been only minor modifications to product design.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium allov screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards.
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Image /page/1/Picture/0 description: The image shows the logo for AESCULAP. The logo consists of a symbol on the left and the word "AESCULAP" on the right. The symbol is a rod with a snake wrapped around it, inside of a circle, which is inside of a square.
510(k) Summary of Safety and Effectiveness
Aesculap Titanium Alloy Bone Screws, page 2 of 2.
Substantial Equivalence
Aesculap believes that the Titanium Alloy Bone Screws presented in this submission are substantially equivalent in design, function, and intended use to Aesculap's current line of bone screws and other existing legally marketed bone screws such as:
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.