(182 days)
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."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity under expected loads | "The implant has been cyclic tested to demonstrate that the device can withstand the expected loads." (No specific load values or cycle numbers are provided, nor are specific pass/fail criteria). |
| Rigidity substantially equivalent to predicate devices | "Evaluation of the material and dimensions demonstrates that the subject device has substantially equivalent rigidity to the predicate devices." (No quantitative metrics for rigidity are provided). |
| Meeting established product requirements (from risk analysis) | "All analyses were verified to meet the required acceptance criteria." (Specific acceptance criteria and performance against them are not detailed). |
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."
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.