(42 days)
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
This document describes a 510(k) premarket notification for the Stryker Imbibe Needle, a manually operated surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria. Therefore, several requested fields related to a detailed performance study are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit, quantifiable acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The comparison points are primarily design features and intended uses, implying that if the new device shares these characteristics and performs similarly, it meets the "acceptance criteria" for substantial equivalence.
| Feature / Criterion | Imbibe Needle (New Device) | Imbibe Needle (Predicate Device, K050795) |
|---|---|---|
| Indications for Use | Aspirating bone marrow or autologous blood + Placement of guidewires | Aspirating bone marrow or autologous blood |
| Product Code | KNW, LXH | KNW |
| Product Design | Handle with cannula, removable stylet | Handle with cannula, removable stylet |
| Stylet Tip Design | Trocar, Beveled | Trocar |
| Fenestrated Offering | Yes | Yes |
| Male Luer Connection For Syringe Attachment | Yes | Yes |
| Sterilization and SAL | Gamma irradiation, 10-6 | Gamma irradiation, 10-6 |
| Biocompatibility | Externally communicating device with tissue/blood/dentin contact for a duration of less than 24 hours | Externally communicating device with tissue/blood/dentin contact for a duration of less than 24 hours |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of a performance study. The document mentions "Preclinical bench data supplied including mechanical and cadaveric testing." However, the exact number of devices tested, samples used in mechanical tests, or cadavers utilized is not provided.
- Data Provenance: The testing appears to be internal preclinical bench and cadaveric testing conducted by Orthovita, Inc. (now Stryker). The country of origin is not specified but implicitly within the US given the FDA submission. It is retrospective in the sense that the data was collected prior to the submission, but the tests were presumably prospective in their execution.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable (N/A): This type of information is pertinent to studies involving human interpretation (e.g., imaging studies, diagnostic tools). The described tests are mechanical and cadaveric, which do not typically involve experts establishing a "ground truth" through consensus or interpretation. The performance is assessed against engineering specifications or physical outcomes.
4. Adjudication Method for the Test Set:
- N/A: As explained above, this concept is not relevant to the type of preclinical bench and cadaveric testing described.
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:
- N/A: This submission is for a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This submission is for a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- For the mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and expected mechanical responses (e.g., force, torque, fatigue limits).
- For the cadaveric testing, the "ground truth" would be the observed physical outcome and ability to perform the intended surgical actions (e.g., successful aspiration, accurate guidewire placement) in a simulated anatomical environment. This is typically assessed against established surgical techniques and anatomical knowledge.
8. The Sample Size for the Training Set:
- N/A: This concept is relevant for machine learning or AI models. This submission is for a physical medical device and therefore does not have a "training set" in that context. The development process would involve iterative design, prototyping, and testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established:
- N/A: As above, this concept is not applicable to the development and testing of a physical surgical instrument.
§ 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.