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The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of:

Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths

Titanium and aluminum combination clamp, 5 & 8 hole pin clamp

Aluminum straight and angled posts

Stainless steel 3mm, 4mm and 5mm pins, blunt tip and threaded 85mm through 250mm lengths, 10mm through 120mm thread lengths.

Stainless steel 5mm transfixing pin, 300mm length

Stainless steel instruments for implantation

The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The provided text is a 510(k) summary for the OIC External Fixation System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI-powered medical device.

The "Performance Testing" section mentions:

• "A geometric comparison was performed on the OIC External Fixation System 3mm pins as compared to the secondary predicate."
• "CAD modeling and analysis were performed on the 3mm pins to evaluate the MRI safety of the new pins."

This indicates engineering and materials testing, not a clinical study or performance evaluation against specific clinical acceptance criteria typically seen for AI/ML medical devices. The device described is a physical external fixation system, not an AI software.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance, ground truth, sample sizes, or expert adjudication, as this information is not present in the provided text.

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The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of:

Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths

Titanium and aluminum combination clamp, 5 & 8 hole pin clamp

Aluminum straight and angled posts

Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths.

Stainless steel 5mm transfixing pin, 300mm length

Stainless steel instruments for implantation

The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The provided text does NOT describe a study involving an AI/ML powered device, but rather a traditional medical device (OIC External Fixation System) used for bone fracture fixation. Therefore, most of the requested information regarding acceptance criteria and study design for an AI/ML device is not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This involves comparing indications for use, operating principles, design, and materials, along with performance testing relevant to the physical characteristics of the device.

Here's a breakdown of what can be extracted from the provided text, and what cannot be provided due to the nature of the device:

Information NOT APPLICABLE/AVAILABLE for this traditional medical device:

• Table of acceptance criteria and reported device performance related to AI/ML metrics: There are no AI/ML metrics (e.g., sensitivity, specificity, AUC) for this device. The "performance testing" mentioned is for MRI compatibility, not diagnostic accuracy.
• Sample size for the test set and data provenance: No test set for AI/ML performance.
• Number of experts and qualifications for ground truth: No ground truth establishment related to diagnostic imaging or AI output.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as there's no AI to assist human readers.
• Standalone (algorithm-only) performance: Not applicable, as it's a physical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML performance.
• Sample size for the training set: Not applicable (no AI/ML model to train).
• How the ground truth for the training set was established: Not applicable.

What is available from the document (relevant to a traditional medical device):

• Device Name: OIC External Fixation System
• Indications for Use: The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
• Performance Testing Mentioned: Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.
• Conclusion of Performance Testing (for MRI compatibility): "Testing shows that the system has acceptable MRI characteristics for the intended uses." This acts as the acceptance criterion for MRI compatibility.
• Predicate Devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional

If this were an AI/ML medical device, here's how the information would typically be structured:

Acceptance Criteria and Study for AI/ML Device (Hypothetical as per your request, but NOT based on the provided document)

This section outlines the acceptance criteria and the study performed to demonstrate that the hypothetical AI/ML device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: [e.g., 500 cases (e.g., 200 positive, 300 negative for the condition)]
• Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan.]

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: [e.g., 3 independent expert radiologists per case]
• Qualifications: [e.g., All radiologists were board-certified with at least 5 years of experience in reading [relevant imaging modality, e.g., chest X-rays] and specialized in [relevant area, e.g., pulmonary imaging]. Additional experts included two board-certified pathologists with 10+ years of experience.]

4. Adjudication Method (for the test set)

• Method: [e.g., 2+1 adjudication. Initial reads by two independent experts. If disagreement, a third senior expert (adjudicator) provided the final consensus. Alternatively: 3+1 (three readers, then a fourth tie-breaker), or Unanimous Consensus, or Majority Vote.]

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

• Was it done? [Yes/No]
  • If Yes:
    • Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
      • [e.g., Human readers using AI assistance demonstrated a statistically significant increase in diagnostic accuracy by X% (e.g., 5.3 percentage points, p

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The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 600mm lengths Titanium and aluminum combination clamp. 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 250mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

This document describes the OIC External Fixation System, a medical device for stabilizing bone fractures. It has been cleared by the FDA under K171211. The document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML product or performance metrics like accuracy, sensitivity, or specificity. Instead, the "Performance Testing" section refers to mechanical testing for external fixation systems.

Since the provided document does not pertain to an AI/ML device, many of the requested fields are not applicable.

Here's the information based on the provided text, with "N/A" for inapplicable fields:

Acceptance Criteria and Device Performance (Mechanical Testing)

While the document doesn't provide a table of acceptance criteria and reported performance in the typical sense of an AI/ML device (e.g., accuracy, sensitivity), it does discuss mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in terms of number of physical units tested, but references Finite Element Analysis (FEA) simulations and mechanical static axial load testing. These tests typically involve a defined number of test samples or simulation runs.
• Data Provenance: N/A (mechanical testing, not patient data).

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

• N/A (Ground truth for mechanical testing is based on engineering specifications and test standards, not expert medical opinion).

4. Adjudication method for the test set:

• N/A (Not applicable to mechanical testing).

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:

• N/A (This device is an external fixation system, not an AI/ML diagnostic or assistive tool).

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

• N/A (Not an AI/ML algorithm).

7. The type of ground truth used:

• Ground Truth Type: Engineering specifications, industry standards (ASTM F1541-02), and mechanical properties of materials.

8. The sample size for the training set:

• N/A (Not an AI/ML device; no training set in the AI sense).

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

• N/A (Not an AI/ML device).

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