(195 days)
The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL).
The QuestLock ACL Fixator is made from Titanium alloy.
This document is a 510(k) summary for a medical device called the "QuestLock ACL Fixator." It provides information about the device's intended use and substantial equivalence, but it does not contain the detailed study information or acceptance criteria requested in your prompt.
Specifically, the document states:
- "The QuestLock ACL Fixator demonstrates acceptable pull out strengths."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Details about a standalone algorithm performance study. (This is a physical device, not an algorithm).
- The type of ground truth used. (It mentions "pull out strengths," which implies quantitative mechanical testing, but no specific ground truth definition is given).
- Sample size for the training set. (Not applicable for this type of device testing).
- How the ground truth for the training set was established. (Not applicable for this type of device testing).
To answer your prompt fully, you would need access to the full 510(k) submission or the detailed testing report referenced in this summary.
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Image /page/0/Picture/0 description: The image shows a close-up of a handwritten alphanumeric string. The string is "K954683" and is written in a bold, rounded font. The numbers are clearly legible, and the letter 'K' is distinct from the numbers.
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter "W" on the left and a more traditional letter "W" on the right. Below the right "W" is the word "MEDICAL" in a smaller font. Underneath "MEDICAL" are the numbers "5 6 7 7" stacked above the letters "A R L I".
APR 2 3 1996
Contact Person: Date:
Cliff Kline October 6, 1995
510(k) SUMMARY
| Trade/Proprietary Name: | QuestLock ACL Fixator |
|---|---|
| Common Name: | Staple, fixation, bone device |
| Classification: | Class II |
| Predicate Devices: | The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL). The fixator is made from Titanium alloy.
Substantial Equivalence
The QuestLock ACL Fixator is substantially equivalent to the The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor.
Testing
The QuestLock ACL Fixator demonstrates acceptable pull out strengths.
§ 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.