(245 days)
Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker® Navigation System's Hip and Knee Modules during orthopedic surgery.
Stryker® Orthopaedics RFID Instrumentation are navigational compatible manual surgical instruments which contain radio-frequency identification (RFID) technology. The RFID tags on the instruments are passive and will not operate without the navigation system. These instruments will be used during orthopedic surgery in conjunction with the Stryker" Navigation System. The instrumentation will be maintained and distributed by Stryker® Orthopaedics, while the navigation system will be maintained and distributed by Stryker® Instruments.
This 510(k) submission for Stryker® Orthopaedics RFID Instrumentation is a submission for Class II medical devices and as such does not contain acceptance criteria and performance study data in the same way a PMA submission for Class III devices would. For 510(k) devices, the primary demonstration is "substantial equivalence" to a predicate device, rather than detailed performance studies against specific acceptance criteria. The information you are requesting is typically not included in a 510(k) summary for this type of device.
Here's why and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable: This type of table is not present because a 510(k) primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The submission asserts "The Stryker® Orthopaedics RFID Instrumentation is substantially equivalent to other navigational compatible instruments in regards to intended use, design, materials, and operational principles." There are no specific performance criteria or reported results in this summary as would be found in a clinical trial report.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable: No test set or associated data provenance (country of origin, retrospective/prospective) is described. The submission is based on a comparison to predicate devices, not on a new clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable: There is no mention of experts establishing ground truth because no new clinical test data requiring such assessment is provided or required for this type of 510(k).
4. Adjudication Method:
- Not Applicable: As there's no test set or ground truth establishment by experts, there's no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: An MRMC study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. This device is a surgical instrument accessory with RFID capability. The 510(k) does not describe any MRMC studies, nor would they typically be relevant for this type of device.
6. Standalone (Algorithm Only) Performance:
- Not Applicable: This device is a physical surgical instrument with RFID tags, not a standalone algorithm. Its function is to be used with a navigation system. Its "performance" would be related to its RFID readability and mechanical integrity, which are assessed through engineering verification and validation, not typically through standalone performance studies like an algorithm.
7. Type of Ground Truth Used:
- Not Applicable: There is no ground truth, expert consensus, pathology, or outcomes data presented because no new clinical study requiring these elements was performed or required for this 510(k). Equivalence is established through comparison of design, materials, and operational principles to predicate devices.
8. Sample Size for the Training Set:
- Not Applicable: This device is not an AI/ML algorithm that requires a training set. Physical product testing would involve engineering and durability tests on a small sample of manufactured instruments, not a "training set" in the context of data science.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable: As there's no training set, there's no ground truth established for one.
In summary: This 510(k) submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices (K022365, K010204, K033341, K043223) rather than presenting new clinical study data with acceptance criteria, test sets, or ground truth establishment. The nature of the device (orthopedic manual surgical instruments with RFID capability) does not typically necessitate the types of performance studies and data analyses you've asked about, which are more common for diagnostic devices, software algorithms, or higher-risk devices.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).