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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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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 CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each mechanical test. It only generally refers to "testing" being performed. The data provenance is pre-market (regulatory submission for 510(k) clearance), suggesting it's from studies conducted by the device manufacturer, In2Bones USA, LLC. The country of origin of the data is not specified but would typically be where the manufacturer's testing facilities are located or where contract research organizations (CROs) performed the tests. The studies are prospective in nature, meaning they were designed and conducted specifically to generate data for this regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The device being described is a mechanical bone fixation system (plates and screws), not a diagnostic or AI-driven device that requires expert-established ground truth for performance evaluation in a clinical or imaging context. The "ground truth" for this type of device is established through engineering and mechanical testing standards and simulations rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons mentioned in point 3. The evaluation of mechanical test results typically involves adherence to recognized standards and objective measurements, not adjudication by human experts in the way clinical studies are adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting medical images or data. The Colink™ Plating System is a surgical implant, and its effectiveness is assessed through mechanical testing and, if applicable, clinical performance data (which is not detailed here beyond the substantial equivalence claim).

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

This information is not applicable. The Colink™ Plating System is a physical medical device, not an algorithm. Therefore, there is no "standalone" algorithm-only performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through objective, standardized mechanical testing data (e.g., measurements of force, torque, displacement) against pre-defined engineering specifications and relevant industry standards for orthopedic implants. It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, which focuses on substantial equivalence based on technological characteristics and mechanical performance.

8. The Sample Size for the Training Set

This information is not applicable. The Colink™ Plating System is an orthopedic implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data acquisition for AI model development.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons mentioned in point 8.

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