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The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.

The provided text describes a 510(k) premarket notification for a medical device called the Haymaker® Screw System. This specific document type, a 510(k) summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study design for a new device's acceptance criteria and performance.

Therefore, the information required to answer your questions regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

The document mentions "Performance Data" and lists mechanical tests conducted (Static Driving and Removal Torque, Torsional Properties, Axial Pullout per ASTM F543). It then concludes that "The results of this non-clinical testing show that the strength of the Haymaker® Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

However, this is not a clinical study proving device effectiveness or safety against specific acceptance criteria in a human population. It's a demonstration of mechanical properties often used to support the claim of substantial equivalence for predicate devices, implying similar performance to already approved devices.

To answer your questions, one would typically need access to a clinical trial report or a more comprehensive performance study report, which is not part of this 510(k) summary.

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The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).

The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device to be implanted from the posterior approach. The system consists of rods, poly-axial screws and set screws. The screws are available in diameters from Ø4.50mm to Ø7.50mm and in lengths of 20mm to 60mm. Standard and Reduction Pedicle Screws are available in these sizes. Titanium rods are available in Ø5.50mm diameter straight and pre-contoured. Set screws are used to fasten the rods and poly-axial screws. Implants are provided sterile in individual packaging.

Special instruments are used to implant the pedicle system. Instruments used to implant the pedicle screw system are provided as non-sterilization prior to use.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

The document is a 510(k) summary for the OrthoCircle Spine Pedicle Screw System, focusing on demonstrating substantial equivalence to predicate devices based on indications for use, materials, structural support, sizes, and specific mechanical performance tests (static compression bending, static torsion, and dynamic compression bending per ASTM F1717-18).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided text.

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