Search Results

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.

Ask a specific question about this device

The Alta® Fully Threaded Cross-Locking 5.0mm Screw is indicated for use in fractures requiring static and dynamic locking applications which include the Intramedullary Rods in the Alta® Femoral and Alta® Tibial /Humeral Rod Systems. Specifically, these screws will be used with the Alta® Femoral Locking IM Rod (K850441 & K822266), the Alta® CFX Reconstruction Rod (K926232, K935295, & K960524), the Alta® Tiblal/Humeral IM Rod (K884500, K890936, and K954554), and the Alta® Retrograde Rod (K972108).

The Alta® Fully Threaded Cross-Locking 5.0mm Screw is a cross-locking screw with continuous threading along the entire shaft. The design modification involves changing the hex head design to a T25 standard drive feature. The modified device will be a new screw for use with the Alta System. The modified component, the Alta® Fully Threaded Cross-Locking 5.0mm Screw, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. Alta® Fully Threaded 5.0mm Screws are manufactured from Titanium (Ti6Al-4V ELI) Alloy, which conforms to ASTM F-136.

The provided document is a 510(k) Premarket Notification for a medical device, the "Alta® Fully Threaded Cross-Locking 5.0mm Screw". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop study details.

Here's why and what information is available:

• Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing design features, materials, intended use, and performance claims (if any new claims are made) to the predicate. It does not usually involve new clinical studies or the establishment of new performance acceptance criteria for the device itself.
• Device Modification: This specific submission is a "Special 510(k)" for a design modification. The modification is changing the hex head design of an existing screw to a T25 standard drive feature. This further emphasizes that it's an update to a known device, not a brand-new one requiring extensive performance evaluations against new criteria.
• Focus on Claims: The document states, "The Alta® Fully Threaded Cross-Locking 5.0mm Screw is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process." This highlights that the review concerns equivalence, not new performance data.

Therefore, I cannot populate the table or answer the questions as the requested information is not present in this 510(k) summary.

However, I can provide the available relevant information from the document:

• Device Name: Alta® Fully Threaded Cross-Locking 5.0mm Screw
• Predicate Device: Osteo System Locking Screw (modified version)
• Design Modification: Changing the hex head design to a T25 standard drive feature.
• Material: Titanium (Ti6Al-4V ELI) Alloy, conforming to ASTM F-136.
• Intended Use: Identical to the Osteo System Locking Screw, for use in fractures requiring static and dynamic locking applications with specific Alta® Intramedullary Rod Systems.
• Regulatory Class: Class II
• Product Code: OR (87) HSB

To answer the detailed questions about acceptance criteria and performance studies, one would typically need access to the full 510(k) submission, including potentially bench testing data or prior predicate device testing documentation, which is not included in this summary.

Ask a specific question about this device