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aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

• Nail in different diameters .
• Interlocking screws in different lenghts ●
• Interlocking nut ●
• Protection cap in different lengths ●
• CondyLock ●
• Accessories, like targeting devices etc. ●

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
• Study Details: Since there's no mention of specific performance testing, there's no information on:
  • Sample sizes for test sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone performance studies
  • Type of ground truth used
  • Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

• Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
• Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
• Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
• Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

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The Titanium Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion). The process of tibiotalocalcaneal arthrodesis using an intramedullary nail usually involves an ankle arthrotomy, preparation of the joint surfaces, and then placement of the nail through a plantar incision. Screws are placed proximally into the tibia in a standard fashion and, after compression, the nail can be locked distally with screws into the calcaneus and the talus.

The indications for tibiotalocalcaneal arthrodesis include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These ankle arthrodesis nails have the same general intended use (arthrodesis, internal fixation of bone), warnings and precautions as those nails previously cleared in K982953. The standard arthrodesis nails are10, 11, and 12 mm in diameter in 15 mm and 18 cm lengths. Longer lengths will be made upon request (up to 46 cm length). The longer nails will be used to treat patients who may require revision of a previously implanted arthrodesis nail due to tibial fracture. Substantially similar titanium femoral and tibial nails in 8, 9, 10, 11, 12, 13 and 14 mm diameters up to 46 cm in length were previously cleared in K982953.

This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. This particular device is a tubular metal rod that is inserted through the talus and into the medullary canal of the tibia to stabilize bone fragments until healing has occurred.

The provided text is a 510(k) premarket notification for a medical device (Titanium Ankle Arthrodesis Nail). It establishes substantial equivalence to a predicate device and outlines the intended use and indications for use. However, it does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.

Medical devices like this intramedullary nail typically demonstrate "acceptance criteria" through various engineering and biocompatibility tests, and often through clinical literature references rather than a single, specific study detailed in a 510(k) summary. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided document.

Here's an attempt to answer based on the available information and general knowledge of 510(k) submissions for similar devices, noting where information is explicitly not present:

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

• Mechanical Properties: Tensile strength, yield strength, fatigue life, torsional strength (meeting ISO standards or equivalent for implantable metals).
• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, genotoxicity, etc., as per ISO 10993 standards.
• Sterility: Demonstrated sterility assurance level (SAL).
• Corrosion Resistance: Meeting standards for implantable titanium alloy.
• Dimensional Accuracy: Conformance to design specifications. | The document states that the device is "substantially equivalent" to predicate devices (Biomet Titanium Intramedullary Nails previously cleared in K982953) and uses "standard technology that is commonly known by physicians." This implies that the device meets the performance and safety profiles of these predicate devices based on the inherent properties of titanium alloy and the established design of intramedullary nails. Specific quantitative performance data is not provided in this summary. |

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

• Sample Size: Not applicable/not provided. This document does not describe a clinical performance study with a distinct "test set" of patients. The substantial equivalence relies on comparison to a predicate device and the known properties of the materials and design.
• Data Provenance: Not applicable/not provided.

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

• Not applicable/not provided. No clinical "test set" requiring ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable/not provided.

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 device is a surgical implant (orthopedic nail), not an AI-powered diagnostic or assistive tool. MRMC studies are for evaluating diagnostic image interpretation by human readers, often with and without AI assistance.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. The "truth" here is established primarily through engineering testing against recognized standards for medical implants and clinical history of similar predicate devices. Outcomes data for a general class of devices (intramedullary nails) in orthopedic surgery would support their effectiveness, but a specific "ground truth" for this device in a study is not mentioned.

8. The sample size for the training set

• Not applicable/not provided. A "training set" is relevant for machine learning algorithms, which this device is not.

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

• Not applicable/not provided.

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These devices are to be implanted into the long bones for alignment, stabilization, and These devices are to be mapantrauma or disease, the fixation of long bones that have Itsation of nactor of thank by transmy for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur.

The G4 nail is an intramedullary rod used to stabilize fractures of the femur. It may be inserted in an antegrade or retrograde fashion.

The provided text describes a 510(k) Premarket Notification for the G4 Sleeved Nail, a femoral intramedullary rod. In this type of submission to the FDA, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive clinical trials as would be required for a novel device.

Therefore, the document explicitly states:

• Clinical Testing: None provided as a basis for substantial equivalence.

This means that while the device is intended for medical use, the application does not contain information about acceptance criteria or a study demonstrating that the device meets those criteria through clinical performance. Instead, substantial equivalence was established through a comparison to predicate devices, focusing on function, labeling, sizing, and non-clinical testing.

Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies, as these elements were not part of this specific 510(k) submission.

The document highlights:

• Non-Clinical Testing: "Testing determined that G4 Sleeved Nail presented no new risks and were; therefore, substantially equivalent to the predicate device. FEA was done in conformance to ASTM F-1264." This indicates physical and mechanical testing, likely to ensure structural integrity and biocompatibility, but not clinical performance.

To summarize, the request cannot be fully answered because the provided document is a 510(k) summary for a device demonstrating substantial equivalence based on engineering and comparison to existing devices, not a clinical study report with acceptance criteria and clinical performance data.

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The Titanium Retrograde Femoral Nail is indicated for internal fixation and stabilization of the femur. These devices are implanted by insertion into the medullary canal of the femur for fixation of open and closed acute distal femoral fractures, pathological fractures, malunions, nonunions, failed plate/screw osteosyntheses of the distal femur, fractures proximal to a total knee arthroplasty, fractures distal to a total hip prosthesis, and fixation of a surgically prepared femur (osteotomy) for correction of deformity.

Femoral nails are to be used for treatment of fractures of the femur including: non-I enoral natis and comminuted mid-shaft fracture, subtrochanteric fracture, distal third comminuted and commination mid bither fransal neck, intertrochanteric fracture, fracture, combination fractures of the mochanteric fractures. Other indications include: combination interactive procedures following tumor resection, and revision procedures where other treatments or devices have failed.

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These 13 mm diameter nails have the same intended use, warnings and precautions as those nails previously cleared in K982953. A new 13 mm size is being added in 20cm, 24cm, 28cm, 32cm, 34cm, 36cm, 38cm, 40cm and 44cm lengths to expand the product line. The 13 mm diameter is larger than the retrograde style nails previously cleared.

This appears to be a 510(k) premarket notification for a medical device, specifically a Titanium Retrograde Femoral Nail. The provided documents describe the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would be relevant for a machine learning or diagnostic device.

The 510(k) pathway for traditional medical devices (like this intramedullary nail) typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new performance studies with acceptance criteria in the same manner as a novel diagnostic or AI device. The "Summary of Safety and Effectiveness" here focuses on the material, design similarity, and intended use compared to existing devices.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable to the provided text. I will address each point based on the information available and note when information is not present or not relevant to this type of submission.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on substantial equivalence to a predicate device rather than a new clinical performance study with a test set. There is no new data provenance or sample size reported for the performance of this specific device model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth assessment by experts for a test set is not part of this 510(k) submission type. The "ground truth" for predicate devices is established through their long-standing use and clinical acceptance over decades.

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

Not applicable. There is no test set or adjudication process described in this submission.

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 implant, not an AI or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This is a medical implant, not an algorithm.

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

For the predicate devices, the "ground truth" for safety and effectiveness is implicitly established through decades of clinical use and physician experience with intramedullary rods for fracture fixation. No specific new ground truth for this device is established beyond its material and design similarity to existing devices. The submission states, "This device utilizes standard technology that is commonly known by physicians."

8. The sample size for the training set

Not applicable. This is a medical implant, not a machine learning model.

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

Not applicable. This is a medical implant, not a machine learning model.

Summary of Device and Approval Context:

The Titanium Retrograde Femoral Nail - 13 MM Diameter is an intramedullary rod used for internal fixation and stabilization of the femur in various fracture scenarios. The 510(k) clearance (K013923) was granted based on the device's substantial equivalence to previously cleared Biomet Titanium Intramedullary Nails (K982953), which themselves were equivalent to devices commercially available since the 1950s. This means the device met the regulatory requirements by demonstrating that its technology, intended use, and fundamental safety and effectiveness profiles are similar to devices already on the market. The FDA determined that no new premarket approval application (PMA) was required because the device does not raise new questions of safety and effectiveness.

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The Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures.

Intramedullary rods (nails) are generally rod-shaped devices, with or without screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary (bone marrow) canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. This device is made of titanium 6AL-4V alloy.

This document is a 510(k) premarket notification for a medical device (Titanium Pediatric Femoral Nail) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical safety and effectiveness through a new clinical trial with specific performance metrics.

Therefore, I cannot extract the requested information from the provided text, as it doesn't exist within this document. The document primarily focuses on:

• Device Description: What the device is and its intended use.
• Potential Risks: General risks associated with this type of device.
• Substantial Equivalence Argument: How this device is similar to previously cleared devices (stainless steel rods and other titanium intramedullary rods).
• FDA Clearance Letter: Formal statement from the FDA that the device is substantially equivalent and can be marketed.
• Indications for Use: The specific medical conditions for which the device is intended.

To answer your questions, one would typically look for a clinical study report or a different type of regulatory submission (like a PMA, which requires clinical data to demonstrate safety and effectiveness).

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