(115 days)
These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach.
These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.
Axon Systems' Stimulus Dissection Instruments are disposable (for "Single Use Only"), sterile devices used for tissue dissection and stimulation of spinal nerve roots for location and identification during surgery.
These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select 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 probing and tissue stimulation. The probes 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 instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively.
The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.
The provided text is a 510(k) summary for a medical device (Axon Systems' Stimulus Dissection Instruments), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be found in a clinical study report.
Therefore, many of the requested sections cannot be filled from the provided text because this type of information is generally not included in a 510(k) summary. A 510(k) emphasizes comparison to legally marketed predicate devices and addresses safety and effectiveness through that comparison, rather than through de novo performance studies with specific statistical endpoints.
Here's how much of your request can be answered based on the provided document:
Acceptance Criteria and Device Performance
The 510(k) summary does not define specific acceptance criteria (e.g., target specificity, sensitivity, or accuracy thresholds) for the device's performance in stimulating spinal nerve roots or for tissue dissection. Instead, it relies on demonstrating substantial equivalence to predicate devices whose safety and effectiveness are already established.
The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use of tissue dissection and stimulation of spinal nerve roots. The document states: "Axon Systems' Stimulus Dissection Instruments are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary. The device is seeking clearance based on substantial equivalence to predicate devices, not specific performance metrics. | The device is deemed "substantially equivalent" to predicate devices for its intended use, implying comparable safety and effectiveness in tissue dissection and stimulation of spinal nerve roots for location and identification during surgery. |
Study Details Not Available in 510(k) Summary:
The following information cannot be extracted from the provided 510(k) summary because it typically pertains to clinical performance studies, which are not usually detailed in a 510(k) submission focused on substantial equivalence to existing devices.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available. A 510(k) of this type typically relies on bench testing, materials testing, and comparison of technological characteristics rather than a clinical "test set" in the context of diagnostic accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not available/Applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available/Applicable.
- 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: Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical instrument, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available/Applicable.
- The sample size for the training set: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Information Available from 510(k) Summary (Relevant to Device Description and Comparison):
- Device Type: Stimulus Dissection Instruments (needles, probes, dilators)
- Intended Use: Tissue dissection and stimulation of spinal nerve roots for location and identification during surgery. Specifically, for pedicle preparation or access to the vertebral body for screw placement in open and minimally invasive procedures to reduce nerve root injury.
- Technological Characteristics: Disposable, sterile, biocompatible electrical insulation, non-insulated stainless steel distal surfaces, proximal connectors, protected pin design meeting IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12. Materials are the same as in predicate devices.
- Predicate Devices:
The clearance is based on the argument that the device's technological characteristics, materials, and intended use are similar to those of previously cleared predicate devices, thus demonstrating substantial equivalence.
§ 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.