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The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.

The provided text is a 510(k) premarket notification letter and summary for the "OIC Small / Mini Fragment Plate System," which is a metallic bone fixation appliance. This document is a regulatory submission for a physical medical device, not a software-based AI/ML device.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device (e.g., acceptance criteria for AI performance metrics like diagnostic accuracy, sensitivity, specificity, AUC; sample sizes for test sets in AI studies; number of experts for ground truth establishment; MRMC studies; standalone algorithm performance; training set details) is not applicable to this submission.

The "Performance Testing" section in the document describes mechanical testing of the plates and screws (bend testing, torsional strength, driver torque, axial pullout strength) according to ASTM standards (F382 and F543). These tests are designed to demonstrate the physical and mechanical integrity and equivalence of the device to predicate devices, which is standard for orthopedic implants.

In summary, this document does not contain the type of information requested for a study proving an AI/ML device meets acceptance criteria.

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The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.

The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.

The document discusses:

• The device's intended use for ankle syndesmosis and fractures.
• The device's components and materials.
• A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
• Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML).
2. Sample size used for the test set and data provenance (for AI/ML).
3. Number of experts used to establish ground truth and their qualifications (for AI/ML).
4. Adjudication method (for AI/ML).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
6. If a standalone (algorithm only) performance study was done (for AI/ML).
7. The type of ground truth used (for AI/ML).
8. The sample size for the training set (for AI/ML).
9. How the ground truth for the training set was established (for AI/ML).

The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.

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The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws.

The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation.

The screws are manufactured material that conforms to:

ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

The provided text describes a 510(k) premarket notification for a medical device called the "OIC Intramedullary Screw System." It details the device's identification, indications for use, description, and comparison to predicate devices, along with performance testing information.

However, the request asks for specific information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of an AI/algorithm-based device. The provided document does not describe an AI/algorithm-based device or any studies related to its performance in classification or diagnostic tasks. Instead, it describes a physical orthopedic implant device (intramedullary screws).

Therefore, I cannot fulfill the request as it is framed, because the document does not contain the information about AI/algorithm performance, ground truth, experts, or MRMC studies. The "Performance Testing" section refers to mechanical testing (torsional, driving torque, axial pullout strength) of the screws themselves, not the performance of an AI system.

To answer your request based on the provided document, the response would be that the document does not contain the information needed to describe the acceptance criteria and study for an AI-based device as requested.

If you are looking for an example of how this information would be presented for a hypothetical AI device based on the structure of your request, I can create a fictional one. Please clarify if that is what you would prefer.

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The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67. The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.

This document describes the OIC Variable Angle Small Fragment Locking Plate System and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device.

Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.

The acceptance criteria here refer to the mechanical properties required for a bone plate system to be considered safe and effective, and the "study" is the performance testing conducted to confirm those properties.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of an AI/ML device study. For mechanical testing, samples were likely taken to represent each type of plate and screw for destructive testing. The data provenance is from in vitro mechanical testing performed by the manufacturer, not from patient data.

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

Not applicable. "Ground truth" for mechanical testing is established by the physical properties measured against industry standards (ASTM). No human experts are involved in establishing this type of ground truth beyond standard laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements.

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 is a medical device (bone plate 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

Not applicable. This is a physical implantable device.

7. The Type of Ground Truth Used

Mechanical Property Standards: The ground truth for this device's performance is adherence to established ASTM (American Society for Testing and Materials) standards for metallic bone plates (ASTM F382) and metallic medical bone screws (ASTM F543-07), and material composition (ASTM F136, ASTM F1472, ASTM F67). These standards define the acceptable range of mechanical properties for such devices to ensure safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical medical device testing.

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

Not applicable. There is no "training set" for this type of medical device submission.

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The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, a dorsal spanning plate, bone pegs, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are pre-contoured to match the anatomy of the distal radius. They accept 2.0mm locking pegs, 2.3mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates. The dorsal spanning plate is being added to the system in this submission.

This document (K212601) is a 510(k) premarket notification for a medical device called the DRPx Locking Distal Radius Plate System. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a clinical setting.

Therefore, the requested information concerning acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be fully provided from this document.

This document describes mechanical performance testing rather than clinical performance.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

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

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

• Test Set Sample Size: Not specified for the mechanical tests. ASTM F382 typically defines the number of samples required for such tests.
• Data Provenance: The mechanical tests were performed by Orthopaedic Implant Company (OIC). The country of origin of the data is implicitly the USA (where OIC is located) if the testing was done in-house or by a US-based laboratory. The testing described is retrospective in the context of device submission, meaning it was completed prior to the submission.

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

• Not applicable. This document describes mechanical testing to industry standards (ASTM F382) and does not involve human experts establishing ground truth for a clinical test set. The "ground truth" for mechanical testing is adherence to the specified test parameters and achieving acceptable results according to the standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This pertains to clinical studies involving human interpretation or assessment, which is not the nature of the described 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

• Not applicable. An MRMC study is relevant for AI-powered diagnostic/interpretive devices. This submission concerns a physical orthopaedic implant, not an AI system assisting human readers.

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

• Not applicable. This pertains to AI algorithms. The DRPx Locking Distal Radius Plate System is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Mechanical Test Standards: For the mechanical performance testing, the "ground truth" is defined by the technical specifications and acceptance criteria of the ASTM F382 standard for metallic bone plates. There is no clinical "ground truth" in this context.

8. The sample size for the training set

• Not applicable. This concept applies to machine learning models, not to the design and testing of a physical orthopaedic implant.

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

• Not applicable. See point 8.

In summary: K212601 is a 510(k) submission for a physical medical device. The "study" mentioned refers to mechanical performance testing performed to demonstrate the device's physical properties meet established engineering standards (ASTM F382). It does not involve clinical trials with human subjects, evaluation of clinical outcomes, or the use of AI. Therefore, most of the requested fields related to clinical studies, human experts, and AI are not applicable to the information contained in this document.

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The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, bone peos, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are precontoured to match the anatomy of the distal radius. They accept 2.0mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws. The bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates.

This a 510(k) premarket notification for the DRPx Locking Distal Radius Plate System. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of an AI/ML device.

Therefore, this document does not contain the information requested regarding acceptance criteria for an AI/ML device and a study proving the device meets those criteria. The provided text describes the regulatory clearance of an orthopedic implant system and focuses on its mechanical properties and equivalence to predicate devices, not on AI/ML performance.

Specifically, the document refers to:

• Performance Testing: Single cycle bend testing and bending fatigue testing performed on the plates per ASTM F382.
• Conclusion: The device was found to have acceptable mechanical characteristics for its intended uses.

This type of testing is relevant for the mechanical integrity of an implant, not for the performance metrics typically associated with AI/ML systems (like sensitivity, specificity, AUC, etc.).

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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 Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.

The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.

I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the OIC Suture Anchor System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, as typically described for AI/ML-based medical devices.

This document is for a traditional, physical medical device (suture anchor system) and primarily establishes substantial equivalence to predicate devices based on:

• Indications for Use: The OIC Suture Anchor System is intended for fixation of soft tissue to bone and supports specific procedures (Shoulder, Elbow, Knee).
• Technological Characteristics: It compares the OIC device's design (PEEK plastic anchors, eyelet, screw-like) and materials (PEEK, stainless steel, aluminum for instruments) to predicate devices.
• Performance Testing: It briefly mentions "Mechanical testing was conducted to ascertain that the suture acceptable characteristics for the intended uses." This is a general statement and does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for the specific information points related to acceptance criteria and a study proving device performance, especially in the context of AI/ML devices (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) from the provided text.

The document details the FDA's clearance process for physical devices, focusing on substantial equivalence, rather than the rigorous performance validation typically required for AI/ML algorithms.

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The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nay be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.

The OIC Intramedullary Nail System consists of the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lad screws are 10.5mm in diameter and range in length from 70mm to 120mm.

The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI.

The additional instruments being added to the OIC Intramedullary Nail System are provided in the non-sterile condition. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle.

This document, K181184, is a 510(k) premarket notification for the OIC Intramedullary Nail System, which is a Class II medical device (Product Code HSB) used for surgical management of femoral and tibial fractures.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm.

The document discusses the addition of fifteen instruments to an existing OIC Intramedullary Nail System (primary predicate device K150655). The substantial equivalence claim is based on:

• Intended use: The new instruments support the existing intended use of the OIC Intramedullary Nail System.
• Materials: The instruments are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle, which are standard materials. The nails, bolts, and screws are made of titanium alloy Ti-6Al-4V ELI.
• Function: The added instruments aid in installing or extracting parts of the system, including tools for suprapatellar insertion of tibial nails.
• Mechanical characteristics: "The instrument constructs were found to have acceptable mechanical characteristics for the intended uses." This implies some form of testing, likely mechanical bench testing, but the details of the acceptance criteria and study are not provided in this document.

The "study" mentioned for establishing substantial equivalence refers to a geometric comparison to predicate devices and evaluation of mechanical characteristics, not a clinical study involving AI/ML performance metrics.

Therefore, I cannot populate the requested information regarding acceptance criteria and an AI/ML study because this document does not contain that type of information. It's a regulatory submission for a traditional orthopedic implant system, not a software as a medical device (SaMD) or an AI-enabled device.

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