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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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Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.

The SIGN Compression Screw System consists of multiple components; self-tapping compression 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 nonsterile.

The provided document is a 510(k) summary for the SIGN Compression Screw System. It describes the device, its intended use, and a comparison to predicate devices, particularly the ASNIS III Cannulated Screw System (K000080).

Please Note: The document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance testing. It does not contain information about acceptance criteria for a diagnostic AI device, nor does it describe a study involving human readers, AI assistance, or the creation of ground truth for a diagnostic algorithm.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of device (a medical implant, not an AI or diagnostic tool) and a different type of regulatory submission (substantial equivalence for a physical medical device, not performance validation for an AI algorithm).

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not applicable/Not provided in the context of an AI device. This document describes mechanical testing for a medical implant. The "acceptance criteria" here are implicitly that the device performs equivalently or better than the predicate in terms of mechanical characteristics.
• Reported Device Performance (from "Performance Data (non-clinical)"):
  • Axial stiffness
  • Load to failure
  • Cyclic fatigue
  • Outcome: "The results support substantial equivalence and did not raise any issues on the safety or effectiveness of the device."

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 document describes mechanical testing of a medical device, not an AI algorithm evaluated on a data set. Therefore, there is no "test set" in the context of diagnostic images or data, nor provenance information for such data.

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. This information is for an AI/diagnostic device. The "ground truth" for the mechanical testing would be the physical measurements of the screws themselves, not expert interpretation.

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

• Not applicable. This information is for an AI/diagnostic device.

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

• No. A MRMC study was not done. This study solely focused on the mechanical performance of the physical screws.

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

• Not applicable. This information is for an AI/diagnostic device.

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

• Not applicable/Not provided in the context of an AI device. For the mechanical testing, the "ground truth" would be the objective physical measurements performed according to established test standards (e.g., ASTM F138).

8. The sample size for the training set

• Not applicable. This document describes mechanical testing of a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned.

Summary regarding AI aspects:

The provided document is a 510(k) summary for a physical medical implant (SIGN Compression Screw System). It details the device's design, intended use, materials, and non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices. It does not contain any information related to AI devices, diagnostic algorithms, or their acceptance criteria or study methodologies. Therefore, most of your questions, which are framed for AI/diagnostic devices, cannot be answered from this text.

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Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.

The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.

This document is an FDA 510(k) Premarket Notification for the SIGN Hip Construct (SHC). It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets clinical acceptance criteria. Therefore, much of the requested information regarding clinical studies, sample sizes, expert involvement, and ground truth generation is not available in this document.

Here's a breakdown of the available and unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance that would be found in a clinical study. Instead, it relies on bench testing to demonstrate equivalent mechanical performance to a previously cleared predicate device.

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

• Sample size for test set: Not applicable and not mentioned. This document describes non-clinical bench testing, not a clinical trial with a "test set" of patient data.
• Data provenance: Not applicable. The "data" refers to results from mechanical bench testing, not patient data.

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

Not applicable. Ground truth for clinical cases is not established as this document describes non-clinical bench testing.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication.

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 (intramedullary fixation rod), not an AI diagnostic tool.

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

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

7. The type of ground truth used

Not applicable. The "ground truth" here is the physical properties and mechanical performance of the device as measured in controlled laboratory settings (bench testing), compared against established standards and predicate device performance.

8. The sample size for the training set

Not applicable. This document does not describe the development of a machine learning model or an algorithm that requires a training set.

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

Not applicable. As above, there is no training set for an algorithm.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating substantial equivalence for the SIGN Hip Construct (SHC) to its predicate devices, primarily K083582 (SIGN Hip Construct (SHC)), K022632 (SIGN IM Nail), and K021932 (Synthes 6.5mm Cannulated Screw).

The study that proves the device meets the acceptance criteria (of substantial equivalence) is non-clinical performance data (bench testing).

• Type of Study: Cyclic fatigue testing simulating walking gait. These tests were explicitly stated to be duplicates of tests performed for the primary predicate device.
• Purpose: To validate that the device can withstand patient use until fracture consolidation occurs and to ensure safety and effectiveness given the expanded indications (reverse oblique fractures and osteotomies) and additional lengths compared to the predicate SHC.
• Results: "The results did not raise any issues on the safety or effectiveness of the device." The conclusion states that the testing data indicates the proposed device is "safe and effective, and performs as well or better than the predicates," supporting the substantial equivalence claim.
• Grounds for Acceptance: Substantial equivalence is established based on the similar design, performance, functions, intended use, and materials to the predicate devices, substantiated by the non-clinical bench testing results.

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The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.

SIGN Pediatric Fin Nail is an Intramedullary Fixation Rod designed to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments The SIGN Pediatric Fin Nails are available in a variety of lengths, shaft diameters, and fin diameters to accommodate a variety of patient anatomies. Each nail has a proximal bend and a slot at the proximal end to accept a solid 4.5mm diameter cortical bone screw for fixation and uses rigid distal fins for rotational stability. The Pediatric Fin Nail may be removed upon fracture healing. The Pediatic Fin Nail is a single use device, supplied non-sterile, and manufactured from stainless steel in accordance with ASTM F 138.

This document describes the SIGN Pediatric Fin Nail, an intramedullary fixation rod designed for femur fracture fixation in pediatric patients. The study supporting its acceptance is a non-clinical performance (bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the device "met all acceptance criteria" for the mechanical performance tests, but does not provide specific numerical values for the acceptance criteria or reported values.

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

• Test Set Sample Size: Not specified in the provided text. The tests were "bench testing" of the device itself, implying a number of manufactured devices were tested.
• Data Provenance: Non-clinical setting (bench testing). No information on country of origin or whether it was retrospective/prospective is applicable as it's not human subject data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a mechanical implant, and the testing was non-clinical bench testing. Ground truth in this context typically refers to the physical properties and mechanical behavior of the device under specific loads, which are measured using scientific instrumentation and engineering standards, not expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As described in point 3, the evaluation was based on objective mechanical measurements against engineering standards, not human interpretation requiring adjudication.

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

No. This type of study (MRMC) assesses the performance of humans, often with and without AI assistance, in interpreting medical images or data. It is not relevant for the evaluation of a mechanical orthopedic implant.

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

Yes, in a way. The performance testing described is standalone in that it evaluates the mechanical properties and performance of the device itself (the "algorithm" equivalent for a physical product) without any human interaction being part of the primary functional assessment. The device's ability to withstand compression, torsion, and fatigue was assessed directly.

7. Type of Ground Truth Used:

The ground truth used was based on engineering standards and predetermined mechanical performance specifications for orthopedic implants, specifically intramedullary rods for fracture fixation. The tests evaluated the device's axial strength, rotational stability, and ability to withstand fatigue under simulated physiological loading.

8. Sample Size for the Training Set:

Not applicable. As a manufactured physical medical device, there is no "training set" in the sense of machine learning algorithms. The design and manufacturing processes are informed by engineering principles, material science, and prior knowledge of similar devices, but not through a "training set" of data.

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

Not applicable. (See answer to point 8). The design parameters, material selection, and manufacturing specifications are established through engineering design processes, material science research, and adherence to relevant ASTM standards (e.g., ASTM F138 for stainless steel). The "ground truth" for its design is rooted in established biomechanical principles and regulatory requirements for implantable devices.

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