(212 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices (e.g., Stryker T2 Ankle Arthrodesis Nail System (K051590)) | "Analysis of strength of the SIGN IM Nail System" performed. |
| No issues raised on safety or effectiveness. | "Results...did not raise any issues on the safety or effectiveness of the device." |
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.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.