(75 days)
Y - Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
The Y-Wire 2 is an orthopedic guidewire with a distinctive distal split tip that is designed to prevent inadvertent advancement of the wire in tissue. Upon exiting a cannula, the distal tips will deploy to stop further advancement past the desired location. By design the distal tip is splayed 300 decrees for a distance of 11mm. The guidwire is made of Nitinol. The Y-Wire 2 is manufactured in five (5) diameters: 1.10mm, 1.40mm, 1.45mm and 1.50mm all have the same length of 560mm.
The provided text describes a medical device, the Y-Wire 2 Orthopedic Wire Passer, but it does not contain acceptance criteria or a study that proves the device meets specific performance criteria beyond basic biocompatibility and packaging validations.
The "Performance Data" section lists three items:
- Biocompatibility: States a study was accomplished to ensure interaction between material and body tissues. This is a general statement and doesn't provide specific acceptance criteria or results.
- Packaging: States that appropriate IQ, OQ, and PQ validations were performed at an ISO 13485 facility, determining the packaging method. Again, no specific acceptance criteria or performance numbers are given.
- Performance - Bench Testing: States that "Static push through force testing demonstrated that the force required to push the Y-wire through a bone test fixture was greater than that for the predicate devices, thus reducing the risk of inadvertent advancement." This is the closest to a performance claim, but it lacks:
- Specific acceptance criteria: What is an acceptable "force required"? How much greater?
- Quantified reported device performance: What was the actual force? What were the forces for the predicate devices?
- Study design details: No information on sample size, how the test fixture simulates bone, or the methodology.
Therefore, I cannot populate the requested table and sections with the information provided because the document does not include detailed acceptance criteria or a comprehensive study report with quantitative performance data.
Here's how I would answer the prompt based on the lack of this information in the text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Y-Wire 2 Orthopedic Wire Passer does not explicitly state detailed acceptance criteria with quantitative thresholds nor does it provide a comprehensive study report with specific performance metrics against such criteria.
The "Performance Data" section broadly outlines three areas: Biocompatibility, Packaging, and Bench Testing. However, it lacks the specific quantitative performance data and the defined acceptance criteria against which the device's performance was measured.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility: Ensure interaction between material and patient body tissues and other related body systems (per FDA Guidance / ISO 10993). | "Biocompatibility study was accomplished to ensure the interaction between the material of the Y-Wire 2 device and patient body tissues and other related body systems to determine the outcome when the device is in use." | No specific quantitative criteria or results provided. The text only states that a study was "accomplished" to "ensure" interaction. |
| Packaging: Validated according to ISO 13485 to determine the method of packaging. | "Safewire, LLC utilized an ISO 13485 packaging facility that accomplished the appropriate IQ (Installation Qualification), OQ (Operating Qualification) and PQ (Process Qualification) packaging validations. These processes when successfully completed through protocol development and final report outcomes determined the method in which the Y-Wire 2 is to be packaged." | No specific quantitative criteria or results provided. The text confirms validation processes were completed but not the performance outcomes relative to any defined acceptance limits (e.g., package integrity, sterile barrier maintenance over time). |
| Static Push-Through Force: Force required to push the Y-Wire through a bone test fixture. | "Static push through force testing demonstrated that the force required to push the Y -wire through a bone test fixture was greater than that for the predicate devices, thus reducing the risk of inadvertent advancement." | Acceptance criteria are implied but not quantified. The criterion seems to be "greater than predicate devices," but no specific force values (N or lbf) are provided for either the Y-Wire 2 or the predicate devices. The magnitude of "greater" is undefined. |
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the document. For the "Static Push-Through Force" bench testing, the sample size of Y-Wires or predicate devices tested is not mentioned, nor is the type or origin of the "bone test fixture."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided as the performance data described relates to physical bench testing, not clinical evaluation requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the performance data described relates to physical bench testing, not image or clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not conducted/not described. The performance data is based on bench testing of the device's physical properties.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical orthopedic guidewire, not a software algorithm.
7. Type of Ground Truth Used
For the static push-through force testing, the "ground truth" would implicitly be the physical measurement of force using appropriate instruments (e.g., a force gauge) in a controlled bench test setting. This is a direct measurement, not a consensus, pathology, or outcomes-based ground truth.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical product, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.