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The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of:

• · Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• · Unstable or painful joint from previous surgery

The RTS® Lesser MTP Implant is intended for use in the treatment of:

• · Partial or complete dislocation of the lesser metatarsophalangeal joint
• · Pain associated with either rheumatoid or osteoarthritis
• · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

The In2Bones CoLink® Plating System / CoLink® View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The CoLink® Afx Plating System is a system of plates and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) and the CoLink® View System has inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK).

The Fracture and Correction System consists of the 5MS® Plate and Screw System and the CoLag® cannulated lag screws used to treat fracture and reconstruction of the bones of the extremities. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6A14V).

The RTS® Lesser MTP Implant System is a double stem silicone implant which is placed into the intramedullary canals of the first metatarsal and proximal phalangeal bones of the forefoot. The RTS® Flexible 1* MPJ Implant w/Grommets System is a flexible silicone great toe implant. Titanium grommets are also available for use in the first metatarsal (only) if the option is desired by the surgeon. The implant is used in the treatment of arthritis of the metatarsophalangeal joint. The implants are made from silicone elastomer NuSil Med 4755 from NuSil.

The In2Bones NeoSpan® Compression Staple Implant is a super elastic compression staple made of superelastic Nitinol (ASTM F2063). The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for various orthopedic implant systems. It discusses the substantial equivalence of these devices to previously cleared predicate devices, primarily based on indications, materials, and geometry.

The "Performance Testing" section states that "MR Testing per ASTM Standards (ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119) was conducted on worst case products to cover all In2Bones product families." This refers to testing for Magnetic Resonance (MR) compatibility and labeling, not a study that proves the device meets specific acceptance criteria in a clinical or performance effectiveness context directly comparable to an AI/algorithm-based medical device.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information about MRMC studies, human reader improvement, or standalone algorithm performance.
5. Type of ground truth, training set size, or how its ground truth was established.

This document focuses on regulatory clearance for traditional medical devices (implants), not AI/ML-based software as a medical device (SaMD) which would typically involve the types of studies and criteria you've requested.

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The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.

The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.

The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

The DePuy Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following. Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates).

The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.

The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are designed to fit into the screw holes of existing DePuy Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation. The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.

The VA 5.0 Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0mm variable angle bone screws. Positioning or cerclage pins are intended for use with cerclage monofilament wire or multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant.

The Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the wire mount hole above the outer surface of the plate, and then twisted with the opposite wire end.

The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.

This document describes the premarket notification (510(k)) for DePuy Synthes' MR Conditional Positioning Pins. The primary purpose of this submission is to add MR Conditional information to the device labeling, indicating that the devices are safe for use in an MR environment under specified conditions. The intended use and technological characteristics of the devices remain unchanged from their previously cleared versions.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are established by adherence to specific ASTM (American Society for Testing and Materials) standards for evaluating medical devices in Magnetic Resonance (MR) environments. The reported device performance indicates that the devices meet these standards, demonstrating safety under specified MR conditions.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for the test set. However, it indicates that testing was performed on "the subject devices" and "the construct" (referring to the device in combination with other materials/implants, where applicable). The data provenance is non-clinical, meaning the testing was conducted in a laboratory setting, not on human subjects. There is no information regarding the country of origin of the data. Given the context of a 510(k) submission to the FDA, it is highly likely these tests were conducted in the US or in a manner compliant with US regulatory requirements. The testing is prospective in the sense that the tests were designed and executed to evaluate the MR compatibility of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This submission relies on non-clinical testing and established ASTM standards. Therefore, there are no "experts" in the sense of medical professionals establishing a clinical ground truth for a test set. The "ground truth" is defined by the parameters and acceptance limits set forth in the ASTM standards themselves, which are developed by consensus among experts in the field of MR safety and material science.

4. Adjudication method for the test set:

Not applicable. This is not a human-reader study requiring adjudication of expert interpretations. The tests are physical measurements and observations against pre-defined ASTM standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for MR Conditional orthopedic implants, not an AI-assisted diagnostic tool. No MRMC study was performed as it is irrelevant to the device's function or regulatory pathway.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (orthopedic pin), not a software algorithm. The "standalone" performance refers to the inherent physical properties and behavior of the device in an MR environment, as detailed in the non-clinical testing.

7. The type of ground truth used:

The ground truth for this evaluation is defined by:

• Established ASTM Standards: These are industry-recognized protocols and acceptance criteria for evaluating MR safety. They represent a consensus on what constitutes acceptable performance for medical devices in an MR environment.
• Physical Measurements and Observations: The tests involved direct physical measurements (e.g., temperature, displacement, torque) and visual observations (e.g., image artifacts) of the devices under controlled MR conditions.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set. The performance is evaluated through material properties and physical testing.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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