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The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions
• Fractures involving osteopenic and osteoporotic bone

The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).

The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).

The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.

The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.

This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.

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

As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for this submission's modifications primarily relies on:

• Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
• Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
• Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.

These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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

Not applicable, for the reasons stated above.

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The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.

The SIGN IM Nail may be removed upon fracture healing.

The SIGN IM Nail system includes Intramedullary nails, Interlocking Screws and Instruments. The SIGN IM Nail is manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138. This device is available with diameters of 9mm, 11mm, 11mm, 12mm, 13mm and 14mm in the following lengths: 280mm, 300mm, 320mm, 340mm, 360mm, 380mm, 400mm. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws. Screws in a range from 25mm to 75mm in 5mm increments are supplied with the nails. Each nail uses distal and proximal bends to accommodate the shape of the femur.

The provided text is a 510(k) Summary and FDA clearance letter for the "SIGN IM Nail." This type of document is for a medical device (an intramedullary nail for fracture fixation), not an AI/ML powered device or a diagnostic device that would typically have acceptance criteria focused on performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, experts, MRMC studies, standalone performance), and training set information is not applicable to this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence for devices like the SIGN IM Nail is typically proven through:

• Comparison of design and materials: The document states the device is "manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138" and details its dimensions.
• Comparison of intended use and indications for use: The document provides a detailed list of indications for use, and states that this 510(k) "serves to extend the SIGN IM Nail line... by adding to the indications for use and providing a greater size range."
• Comparison of performance data (if applicable to non-AI devices): For mechanical devices like this, performance data usually involves mechanical testing (e.g., fatigue, static bending strength, torsional strength) to demonstrate that the new device performs at least as well as, or better than, the predicate devices in terms of mechanical properties. This document does not explicitly detail such mechanical test results, but it would have been part of the full 510(k) submission. The FDA's clearance letter implicitly confirms that such data was found acceptable.
• Safety information: The safety of the device is implicitly demonstrated by its similarity to long-marketed predicate devices and adherence to material standards.

Since the prompt specifically asks for details relevant to AI/ML or diagnostic device performance studies, and this document does not contain that type of study, I cannot fill in the requested table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies.

The closest analogue to "acceptance criteria" for this device would be that its design, materials, and mechanical performance (demonstrated via engineering tests, not clinical studies as described in the prompt) are substantially equivalent to and as safe and effective as the predicate devices.

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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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