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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 EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.

A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.

The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:

• . Metal femoral components manufactured from cobalt chrome alloy
• . Femoral revision accessories, including augments, manufactured from titanium alloy
• . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
• . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
• Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
• . Patellae manufactured from UHMWPE and cobalt chrome alloy

The provided text is a 510(k) Summary for a medical device (EVOLUTION® Knee Systems – MR Labeling) and outlines nonclinical testing conducted to establish the device's conditional safety and compatibility in a magnetic resonance (MR) environment. It does not describe a study involving device performance against acceptance criteria in the usual sense of diagnostic accuracy or clinical outcomes, but rather safety and compatibility within an MR environment.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical or diagnostic performance are not applicable to this document. I will focus on what is provided regarding the MR safety testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format for MR safety. Instead, it refers to industry standards that define safe limits. The reported "performance" is that the device met these standards and showed no safety issues.

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

The document states, "The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts." It refers to "passive implants" but does not specify the exact number of components or constructs tested.

• Test set sample size: Not explicitly stated as a numerical count of individual devices, but "worst case components and constructs" were tested.
• Data provenance: Nonclinical testing performed according to U.S. FDA guidance and international standards (NEMA, ASTM). The location of the testing laboratory is not specified (e.g., country of origin).

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

This question is not applicable. The testing was nonclinical (MR safety testing), not involving human diagnostic interpretation or ground truth establishment by medical experts.

4. Adjudication method for the test set

This question is not applicable, as it was nonclinical testing, not involving human readers or interpretation requiring adjudication.

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

There was no MRMC comparative effectiveness study described, as this document concerns the MR safety labeling of knee implant systems, not an AI-assisted diagnostic device.

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

This question is not applicable. The device is a knee implant system, not an algorithm.

7. The type of ground truth used

For an MR safety study, "ground truth" typically refers to the physical properties of the materials and their behavior in an MR field as measured by calibrated equipment following established standards. It's not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. The ground truth is the quantitative measurements against the physical laws and established safety thresholds described by the ASTM and NEMA standards.

8. The sample size for the training set

This question is not applicable. This is not a machine learning or AI device that requires a training set.

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

This question is not applicable as there was no training set.

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