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The SIGN IM Nail System is indicated for tibiotalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.

The SIGN IM Nail System consists of multiple components; Standard IM Nail, Interlocking Screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided non-sterile.

This is a 510(k) premarket notification for the SIGN IM Nail System, an orthopedic intramedullary rod. The document discusses the device's indications for use, its comparison to predicate devices, and non-clinical performance data.

Here's an analysis of the provided text in relation to your request:

Key Takeaway: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily extensive clinical trials proving novel efficacy. The "performance data" mentioned refers to non-clinical testing. Therefore, many of your requested points related to human clinical studies, ground truth establishment, and MRMC studies will not be found in this type of submission.

Here is the information extracted and organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific numerical acceptance criteria (e.g., minimum tensile strength, fatigue cycles) for mechanical performance tests are not explicitly stated. The document broadly states that "The results of the performed tests support substantial equivalence to legally marketed predicate devices and did not raise any issues on the safety or effectiveness of the device."

The criteria are implicitly related to demonstrating equivalent mechanical performance to predicate devices under relevant ASTM standards or internal protocols.

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

• Sample Size: Not specified in the provided text. The document refers to "non-clinical tests," which would typically involve a specific number of devices tested, but this number is not disclosed.
• Data Provenance: The tests are "non-clinical," meaning they were conducted in a lab environment. There is no mention of country of origin of data or whether it was retrospective or prospective, as these terms apply to clinical studies.

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

This point is not applicable as the document discusses non-clinical mechanical testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This point is not applicable as the document discusses non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.

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

This point is not applicable. The device is an orthopedic intramedullary nail, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was assessed.

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

This point is not applicable. The device is a surgical implant, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, "ground truth" would correspond to established engineering standards, material properties, and biomechanical principles. For example, testing to ASTM F138 for Stainless Steel, or specific fatigue and load-bearing tests. The document indicates "analysis of strength" and implies comparison to predicate devices, suggesting that the "ground truth" is engineering performance data, not clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set

This point is not applicable as the device is a physical implant, not an AI model that requires a training set.

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

This point is not applicable as the device is a physical implant, not an AI model that requires a training set.

Summary of Study Type:

The study described is a non-clinical performance evaluation (mechanical testing) aimed at demonstrating substantial equivalence of the SIGN IM Nail System to existing predicate devices (specifically, the Stryker T2 Ankle Arthrodesis Nail System (K051590)). This type of study focuses on the device's physical and mechanical properties rather than clinical outcomes or diagnostic accuracy.

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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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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.
The SIGN IM Nail may be removed upon fracture healing.

The SIGN IM Nail system includes Intramedullary nails. Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN IM Nail is available with diameters of 8mm. 9mm. 10mm, 11mm, and 12mm in the following lengths: 150mm, 190mm, 270mm, 270mm, 280mm, 320mm, 320mm, 340mm, 360mm, 380mm, 400. Each nail is made from a solid type 316. ASTM F138, stainless steel bar with distal and proximal bends. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws.

This document describes a medical device, the SIGN IM Nail, which is an intramedullary nail for internal fixation of certain fractures. It is a traditional medical device, not a software algorithm or AI-powered solution. Therefore, the requested information about acceptance criteria, study findings, sample sizes for test and training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in the context of AI/algorithm performance.

The document states that the safety and effectiveness of the SIGN IM Nail is based on a long history of use of this type of device in the market place and its substantial equivalence to predicate devices (Smith & Nephew "TriGen®" Knee Nail, ACE Medical "AIM" Titanium Tibial Nail, Synthes "Universal Nail").

The FDA's decision to clear the device (K013132) is based on a substantial equivalence determination, meaning it is similar in intended use, technology, and performance to legally marketed devices. This process typically relies on device comparisons, material testing, and sometimes bench or animal testing, rather than the kind of clinical performance studies with specific acceptance criteria that would apply to AI/software.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI study, nor can I provide information on sample sizes, ground truth, or expert involvement as these are not relevant to the substantial equivalence pathway for this type of conventional device.

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Ask a specific question about this device