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The CrossRoads Screw System is indicated for fracture repair and fixation, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.

This document is a 510(k) premarket notification for the "CrossRoads Screw System." It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to a medical device (screw system) rather than a diagnostic or AI-based device that would typically have performance metrics like sensitivity, specificity, or accuracy.

The document is a submission to the FDA seeking clearance for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices. The information provided is primarily regulatory and descriptive.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.

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The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction.

The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.

The design features of the CrossTie™ Intraosseous Fixation System are summarized below:

• Implant Grade PEEK o
• Sized to accommodate patient anatomy O
• O Solid, one piece construction for all devices
• Proximal and distal barb-like features for secure placement o
• Hole to optionally aid in joint reduction O

The provided text is a 510(k) premarket notification for a medical device called the "CrossTie™ Intraosseous Fixation System". This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way a clinical trial or a performance study for a novel AI/software medical device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this regulatory submission context. This document primarily relies on design verification analysis and material/dimensional evaluation to show equivalence to existing devices.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported performance for specific metrics. Instead, it relies on demonstrating that "All analyses were verified to meet the required acceptance criteria" and that the device has "substantially equivalent rigidity to the predicate devices" based on "design verification analysis" and "evaluation of the material and dimensions."

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

• Sample Size (Test Set): Not applicable for the type of testing described. The document refers to "design verification analysis" and "cyclic tested," which typically involve a limited number of device samples in a laboratory setting, not a "test set" in the context of clinical data or AI validation.
• Data Provenance: Not applicable. The testing described is in-vitro mechanical testing.

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

• Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

4. Adjudication method for the test set

• Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

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 device is a surgical implant, not an AI or imaging diagnostic tool.

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

• Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

• Mechanical Engineering Principles / Industry Standards: The "ground truth" for this device's performance is based on established mechanical engineering principles, material science, and potentially relevant ASTM or ISO standards for medical implants. The goal is to demonstrate that the device's mechanical properties (e.g., strength, rigidity, fatigue resistance) are suitable for its intended use and equivalent to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

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

• Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

Summary of Key Information from the Document:

• Device: CrossTie™ Intraosseous Fixation System
• Purpose of Submission: New Device 510(k) for substantial equivalence to predicate devices.
• Intended Use: Aid in the fixation of fractures, fusions, and osteotomies of the toes (e.g., hammertoe, claw toe, mallet toe, interdigital fusions).
• Predicate Devices: K133636 – HammerFix IP Fusion System, K113006 – PhaLinx Hammer Toe System, K120165 - CannuLink Instraosseous Fixation System, K073674 – Kirchner Wires.
• Performance Testing Mentioned:
  • Design verification analysis performed to meet acceptance criteria derived from risk analysis and product requirements.
  • Evaluation of material and dimensions to demonstrate substantially equivalent rigidity to predicate devices.
  • Cyclic testing to demonstrate the device can withstand expected loads.
• Conclusion: The manufacturer asserts that "minor differences between the subject and predicate devices...are insignificant in the safety and efficacy of the devices" and that the subject device "is substantially equivalent to the predicate devices."

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The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.

The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.

The design features of the CrossCLIP™ Implant System are summarized below:

• Implant Grade Nitinol (ASTM F2063-12) o
• O Various sizes to accommodate patient anatomy
• o One piece construction
• Barbs to resist pull-out O
• O Single use, sterile packaged instruments

The provided text is a 510(k) summary for the CrossCLIP™ Implant System, which is a medical device used for bone fixation. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document is a premarket notification from the FDA, confirming substantial equivalence to predicate devices, rather than a detailed scientific study report. It mentions "design verification analysis" and "performance testing" but does not provide the specifics of these tests as requested.

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

• Cannot be fully provided. The document states: "Results of the design verification activities met the required acceptance criteria." and "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices." However, it does not list the specific acceptance criteria or the reported device performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document refers to "design verification analysis" and "performance testing" but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.

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 / Cannot be provided. This type of information is typically related to diagnostic or imaging device performance where expert review establishes ground truth. The CrossCLIP™ Implant System is a physical bone fixation device, and its performance testing would likely involve biomechanical or material properties testing, not expert interpretation of diagnostic data. The document does not mention any expert review process for establishing ground truth related to its performance studies.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in diagnostic studies involving inter-reader variability. This document does not suggest such a method was used for the device's performance testing.

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 document describes a physical medical device (bone fixation implant), not an AI algorithm or a diagnostic aid. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Cannot be provided definitively. Based on the nature of the device (bone fixation implant), "ground truth" for performance testing would typically involve objective biomechanical measurements (e.g., pullout strength, compression force, fatigue life) compared against established standards (like ASTM F2063-12) or predicate device performance. However, the document does not explicitly state the type of ground truth used, only that performance was "verified against the predicate device" and "ASTM F2063-12 Standard Specification."

8. The sample size for the training set

• Not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set for a machine learning model is involved.

Summary of available information from the document:

• Device Name: CrossCLIP™ Implant System
• Intended Use: Hand and foot bone fragment osteotomy fixation and joint arthrodesis.
• Regulatory Status: Substantially equivalent to predicate devices (K070031 and K124045).
• Performance Testing Mentioned: "Design verification analysis" and "Performance Testing" against predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
• Conclusion of Performance Testing: "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices."

To answer your request comprehensively, a detailed study report or technical documentation outlining the specific tests performed (e.g., mechanical testing protocols), their results, and the acceptance criteria used would be required, which is not present in this FDA 510(k) clearance letter.

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