(114 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. Furthermore, the surgeon may optionally elect to use suture that passes through the distal end of the implant for closure.
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:
- O Implant Grade PEEK
- O Sized to accommodate patient anatomy
- Solid, one piece construction for all devices O
- Proximal and distal barb-like features for secure placement O
- Hole to optionally aid in joint reduction O
Here's a breakdown of the acceptance criteria and study information based on the provided text for the CrossTie™ Intraosseous Fixation System:
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not contain a specific table or detailed quantitative acceptance criteria for this specific submission (K151270). However, it states that "All analyses were verified to meet the required acceptance criteria." and "Evaluation of the system with and without utilizing the suture for closure demonstrates that the subject device is substantially equivalent in static and fatigue performance compared to the predicate device."
Since K151270 is an update to a previously cleared device (K141857) with only a minor change (surgical technique for suture use), the performance focus is on demonstrating equivalence to the predicate. The performance testing section mentions "static and fatigue performance" as key areas.
Based on the text, the implicit acceptance criteria would be equivalence in static and fatigue performance to the predicate device (K141857).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Performance Equivalence to Predicate Device (K141857) | The evaluation of the system (with and without suture) demonstrates that the subject device is substantially equivalent in static performance compared to the predicate device. |
| Fatigue Performance Equivalence to Predicate Device (K141857) | The evaluation of the system (with and without suture) demonstrates that the subject device is substantially equivalent in fatigue performance compared to the predicate device. The implant has been cyclic tested with and without suture to demonstrate that the device can withstand the expected loads. |
Important Note: The document does not provide the specific quantitative thresholds or numerical results for static or fatigue performance, only the conclusion of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is likely bench testing (in vitro) rather than human or animal studies, given the nature of the device (fixation system) and the mention of "cyclic tested."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described performance testing (static and fatigue) would involve engineering analysis and physical testing, not expert interpretation of outputs to establish ground truth in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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
An MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic AI devices where human readers interpret medical images. The CrossTie™ Intraosseous Fixation System is a surgical implant, and its evaluation focuses on mechanical performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical intraosseous fixation system, not an algorithm. Performance testing would be of the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on engineering principles and mechanical testing standards. The performance attributes (static and fatigue strength) are measured empirically through physical tests, not through expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The CrossTie™ Intraosseous Fixation System is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.