(74 days)
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No
The device description and intended use are for a mechanical bone screw, and there is no mention of AI or ML in the provided text.
Yes
Explanation: The device is intended for "fracture fixation of large bones and large bone fragments," which directly treats a medical condition (fractures) and thus serves a therapeutic purpose.
No
The device, Synthes 7.0/7.3 mm Cannulated Screws, is described as hardware for "fracture fixation of large bones and large bone fragments." It is an orthopedic implant used for treatment, not for diagnosing conditions.
No
The device description clearly describes physical hardware components (screws made of stainless steel or titanium alloy) used for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of large bones and large bone fragments." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (screws) made of stainless steel or titanium alloy, designed for surgical insertion into bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a surgical implant used for orthopedic fixation, not a diagnostic tool used on in vitro samples.
N/A
Intended Use / Indications for Use
Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.
Product codes
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Device Description
Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
large bones and large bone fragments
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on mechanical testing, Synthes 7.0/7.3 mm Cannulated Screws are at least equivalent to Synthes 6.5 mm Cancellous Screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a circled "R" symbol to the left and a registered trademark symbol to the right. To the right of the word "SYNTHES" is the text "K 96 2011" in a handwritten style. The text is black and the background is white.
Summary of Safety and Effectiveness Information Attachment VI:
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri May 21, 1996
Synthes Sterile 7.0/7.3 mm Cannulated Screws are compared to Synthes 6.5 mm Cancellous Screws.
Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments. Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.
Additionally, the Ace 6.5 mm Ti Cannulated Cancellous Screw System, the Richards 8.0 mm Cannulated Screw, and Zimmer Magna-Fx Cannulated Screw Fixation System are commercially available devices that are also similar to the 7.0/7.3 mm Cannulated Screws.
Synthes 7.0/7.3 mm Cannulated Screws will be provided sterile; Gamma radiation will be used to sterilize the device.
Based on mechanical testing, Synthes 7.0/7.3 mm Cannulated Screws are at least equivalent to Synthes 6.5 mm Cancellous Screws.