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The In2Bones USA LLC, CoLink® Plating System / CoLink® View Plating System / CoLink® Mini 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 CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System and Fracture and Correction System are previously cleared plate and screws systems. The scope of this submission is to add a new packaging system for the previously cleared screws. The screws are all made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V). The implants are MR conditional.

This document is a 510(k) Premarket Notification from the FDA regarding orthopedic plating and screw systems. It does not describe an AI/ML medical device or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that the submission's scope is to "add a new packaging system for the previously cleared screws" and mentions that the products are "identical in indications, materials and geometry." The "Performance Testing" section lists validations related to sterilization, packaging, shelf life, and biocompatibility, which are standard for physical medical devices, not AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an AI/ML device meets them from this document. The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies.

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

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

The In2Bones Fracture and Correction System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The scope of this submission is to add smaller diameter CoLag™ Screws as well as a version of all lag screws within the system that has a modified tip design. All screws are manufactured from Titanium Alloy conforming to ASTM F136.

The provided document is a 510(k) summary for the In2Bones Fracture and Correction System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through direct comparison of indications, materials, and geometry, as well as performance testing.

Crucially, this document describes a traditional medical device (bone fixation system) and not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The document demonstrates equivalence based on:

1. Indications for Use: The subject device has similar intended uses for treating fractures, fusions, osteotomies, and non-unions of various bones, aligning with its predicate devices.
2. Material: The device is made of Titanium Alloy (ASTM F136), which is consistent with the primary predicate and some additional predicates. One predicate uses Stainless Steel, but the overall material conformity is deemed acceptable.
3. Geometry and Dimensions: The subject device introduces smaller diameter CoLag™ Screws and a modified tip design but remains within the range of dimensions and geometries of the predicate devices.
4. Performance Testing: Non-clinical tests were conducted:
   • Insertion/Removal Testing
   • Static Pull-out Testing
   • Torque Capacity Testing (per ASTM F543)
     These tests confirmed that the subject device performs substantially equivalently to the predicate.

Therefore, I cannot provide the requested information about AI/ML acceptance criteria and study details because the provided text describes a physical medical device clearance, not an AI/ML device.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will gladly describe its acceptance criteria and study details based on that information.

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

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

The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.

The provided text describes the regulatory clearance for the "In2Bones Fracture and Correction System," a medical device consisting of plates, screws, and washers used for bone fixation. However, the document does not contain information about acceptance criteria, device performance metrics, or study design details in the way requested by the prompt (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment, or training set details).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through performance data confirming the mechanical properties of the device rather than clinical or AI algorithm performance.

Here's what can be extracted from the document regarding "performance data," albeit not in the format of AI algorithm acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, the device underwent various mechanical tests to demonstrate its substantial equivalence to predicate devices. The specific acceptance criteria (e.g., minimum torque values, maximum displacement under load) are not explicitly stated in this summary but are implied by the statement that the testing "demonstrate[s] that the device is substantially equivalent to the predicate devices identified."

Missing Information (Regarding the original prompt's questions):

The document does not provide details for the following requested items as they are not relevant to a 510(k) submission for a mechanical bone fixation system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. "Test set" here refers to physical device samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by engineering standards and measurements, not medical expert consensus.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, but a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: For mechanical tests, the ground truth is derived from engineering measurements and established standards.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary from the provided text:

The In2Bones Fracture and Correction System demonstrated "substantial equivalence" to identified predicate devices (K123241, K983495, K131920, K160174) by undergoing mechanical performance testing, including pyrogenicity, static driving torque, static pullout, static torsion, static bending, and fatigue bending tests. The results of these tests (namely, that the device performed adequately to be deemed substantially equivalent) are reported, but the specific numerical acceptance criteria or detailed outcomes of each test are not provided in this 510(k) summary. The device's "acceptance criteria" were met by establishing that its technological characteristics and performance were comparable to legally marketed predicate devices, ensuring its safety and effectiveness.

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