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The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.

Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.

The system is not intended for spinal use.

The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate is made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a medical device, the I.T.S. Fibula Plate PROlock with Angular Stability, and its 510(k) summary for clearance by the FDA. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices, not on demonstrating specific performance metrics against defined acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or an MRMC study based on the provided text.

Here's why and what information is present:

• Acceptance Criteria and Reported Device Performance: This information is completely absent. The document is about regulatory clearance based on substantial equivalence, not performance testing.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of this is mentioned. The clearance is based on the device's design, materials, and intended use being similar to already marketed devices. The document does not describe a clinical study in the way you've outlined.

Information that is available in the provided text:

• Device Name: I.T.S. Fibula Plate PROlock with Angular Stability
• Intended Use/Indications for Use: Titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula, including metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions, corrective osteotomy, and open and closed fractures. Not intended for spinal use.
• Materials: Plate from CP Titanium (ASTM F 67-00), screws from 6-4 Alloyed Titanium (ASTM F 136-02).
• Regulatory Pathway: 510(k) premarket notification.
• Substantially Equivalent Devices (Predicates): Synthes Semi-Tubular Plate, Synthes Small Fragment System, Synthes 4.5mm LCP Straight Reconstruction Plates, Synthes LCP Distal Tibia Plates, Synthes One-Third Tubular DCL Plate, Synthes Curved Reconstruction Plate, Synthes Medial Distal Tibia Plates, Zimmer Periarticular Plating System, Acumed Lower Extremity Congruent Plate System.

In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a report on a study demonstrating performance against acceptance criteria.

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The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon).

The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Olecranonplate with Angular Stability." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

Specifically, the text includes:

• Device Description: The I.T.S. Olecranonplate with Angular Stability is a low-profile universal titanium plate with various length cancellous self-tapping and head locking stabilization screws, and cortical screws. It is made from CP titanium and 6-4 alloyed titanium.
• Intended Use/Indications for Use: Fixation of complex intra- and extra-articular fractures, osteotomies, nonunions, malunions, and various types of simple and complex fractures of the proximal ulna (olecranon).
• Basis of Substantial Equivalence: It is substantially equivalent to Acumed Olecranon Plate, Synthes Curved Reconstruction Plate, and Zimmer Zuelzer Hook Plate for fracture of the Olecranon.
• Summary of Safety and Effectiveness: States that the device is "shown to be safe and effective for use in fracture fixation of the proximal ulna (olecranon) in the elbow," but does not provide details of any study or acceptance criteria used to demonstrate this.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study's methodology as this information is not present in the given text.

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