(11 days)
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, retractors, awls, taps, needles, probes, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for mechanical, manual dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
The provided 510(k) summary (K031003) for the Medtronic Xomed "Stimulus - Dissection Instruments" does not contain a detailed study with specific acceptance criteria and reported device performance in the way a clinical trial or algorithm performance study would.
Instead, this 510(k) is a substantial equivalence submission, meaning the manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, without requiring new clinical performance data in the same way. The "acceptance criteria" here relate to meeting the characteristics of the predicate device and relevant standards.
Here's a breakdown based on the provided text, addressing your points as much as possible within the context of a 510(k) summary for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k), the "acceptance criteria" are not performance metrics in a clinical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, they are the design, material, functional, and safety characteristics that allowed the device to be deemed substantially equivalent to its predicate. The "reported device performance" is implicitly that it meets these characteristics, making it comparable to the predicate.
| Acceptance Criteria (Characteristic of Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications For Use: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | Meets: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. |
| Construction: Stainless steel | Meets: Yes |
| Electrical insulation: On all surfaces not intended to provide electrical contact with the patient | Meets: Electrical insulation on all surfaces not intended to provide electrical contact with the patient |
| Distal patient contact surface: Stainless steel | Meets: Yes |
| Proximal stimulator connector: Yes | Meets: Yes |
| IEC 60601-1 Protected Pin design: Yes | Meets: Yes (Meets IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12) |
| Biocompatible: Yes | Meets: Yes |
| Use: Single Use, Sterile | Meets: Yes |
Implicit Acceptance Criteria (not explicitly in the comparison table but mentioned in device description):
- Design: Similar to existing stainless steel manual surgical instruments.
- Function: Provide for mechanical, manual dissection/resection, and tissue stimulation.
- Safety: The instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.
The "study" that proves the device meets the acceptance criteria is simply the detailed comparison provided by Medtronic Xomed in their 510(k) submission, confirming that their proposed device shares the critical characteristics and intended use of the predicate device (K014165) and adheres to relevant safety standards.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) summary. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new clinical performance study with a "test set" of patients or data. The "data provenance" would refer to the technical specifications and design documentation provided by Medtronic Xomed for their new device, comparing it to the specifications of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. There was no "test set" requiring expert ground truth establishment for this 510(k) submission, as it's not a performance study of a diagnostic or AI device. The "ground truth" for showing substantial equivalence resided in the technical specifications and regulatory clearances of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an MRMC study and does not involve human readers interpreting data. It's for a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This device is a manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the pre-existing regulatory classification, safety, and effectiveness profile of the predicate devices (Medtronic Xomed Stimulus Dissection Instruments cleared via K014165 and Medtronic Xomed Monopolar Stimulator Probes originally described in K992869). The manufacturer's submission's "truth" is that their new device aligns with these established characteristics and design standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.