(81 days)
Transposition of Anterior Tibial Tuberosity Possibility of compression without adding any washer.
This is a single-use, permanent internal device. This is a Flat-headed, partially threaded screw, designed to be used without any washer. This screw is available in six sizes : (40, 45, 50, 55 and 60 mm). This screw is madeof surgical implant Titanium, Ti6Al4EVELI, according to ASTM-136-92 or to ISO 5832-3-90.
The provided text describes a medical device, the J.B.S T.T.A screw, and its indications for use, contraindications, and substantially equivalent devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in your prompt.
The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for an FDA 510(k) premarket notification (K955710). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results and clinical performance data in the way you've outlined for an AI/ML medical device.
Therefore, it is impossible to answer your request using the provided input.
To answer your questions, I would need a document that describes a clinical performance study, often found in a clinical study report, a scientific publication, or a more detailed FDA submission (like a PMA or a more extensive 510(k) supporting document that includes performance data, if applicable).
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SUMMARY OF SAFETY AND EFFECTIVENESS
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory authority : Company : J.B.S Parc d'activités Savipol 10000 Ste Savine, Troyes Tel : 011-33-2571-2500 MAR - 4 1996 Fax : 011-33-2571-2506 Medical Device Establishment Registration # : 9681258 FDA Owner/Operator # : 9021265 Contact : Mrs Liza Burns, Regulatory consultant. Trade name : J.B.S T.T.A screw Common name : T.T.A screw Classification : Bone, fixation, screw Classification Code : 87 KWC. Device description : This is a single-use, permanent internal device. This is a Flat-headed, partially threaded screw, designed to be used without any washer. This screw is available in six sizes : (40, 45, 50, 55 and 60 mm). This screw is madeof surgical implant Titanium, Ti6Al4EVELI, according to ASTM-136-92 or to ISO 5832-3-90.
Indications or use :
Transposition of Anterior Tibial Tuberosity Possibility of compression without adding any washer.
Contraindications :
The J.B.S T.T.A is not to be used for patients with active localized or systemic intection, patients who are pregnant or patients who have disease or other medical condition which inhibits the potential of bony fusion. (i.e., osteoporosis, kidney analysis, etc.).
Substantially equivalent devices .
1 - The partially threaded bone screw manufactured by Howmedica, Inc.
2-The partially threaded bone screw manufactured by Synthes.
Distributed by J.B.S USA 204E Blithedale Avenue Mill Valley. CA 94941
Made in France by J.B.S Parc d'activités Savipol 10300 Ste Savine, Troyes.
§ 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.