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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:

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.

2. 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.
3. 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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available/Applicable.
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: Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available/Applicable.
8. 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.
9. 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:
  • Medtronic Xomed, "Stimulus Dissection Instruments" (K031003)
  • Axon Systems, Inc., "Disposable Stimulator Probes" (K062996)
  • Nuvasive, "Surgical Nerve Stimulator/Locator" (K002677)

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.

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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.

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.

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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, forceps, retractors, 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 noninsulated stainless steel to provide for mechanical, manually actuated 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.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission (K014163) for the Stimulation/Dissection Instruments does not contain explicit acceptance criteria or a dedicated study section detailing performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

Summary of Device Performance and Substantial Equivalence:

The core of this submission is a comparison table outlining the characteristics of the Stimulus - Dissection Instruments and the predicate device, Ball-Tip Monopolar Stimulating Probe [K992869]. The "reported device performance" is essentially that the new device shares the same fundamental characteristics and intended use as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not stated, I will infer them from the characteristics listed for substantial equivalence. The "Reported Device Performance" will reflect that the new device meets these inferred criteria by being "Yes" where applicable.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable (N/A) for this type of submission. This submission does not include a dedicated clinical or performance study with a test set. The substantial equivalence argument relies on the comparison of design features and intended use with a predicate device.
• Data Provenance: N/A. There is no new data from a test set presented. The "data" here is descriptive of the device's design and functions, and a comparison to an existing, legally marketed device.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: N/A. No ground truth was established by experts for a test set, as no performance study was conducted.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set:

• Adjudication Method: N/A. No test set requiring ground truth adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done: No. This submission does not describe an MRMC study or any comparative effectiveness study with human readers. The device is a surgical instrument with a stimulation function, not an AI-powered diagnostic tool. The focus is on the safety and effectiveness of the instrument itself, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done: No. This device is a physical surgical instrument; it is not an algorithm, and therefore, a standalone algorithm performance study is not relevant or included.

7. Type of Ground Truth Used:

• Type of Ground Truth: N/A. No ground truth in the context of a performance study (e.g., pathology, outcomes data, expert consensus on diagnostic findings) was used. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device and relevant standards (e.g., IEC 60601-1).

8. Sample Size for the Training Set:

• Sample Size for Training Set: N/A. This device does not involve machine learning or AI, so there is no "training set."

9. How Ground Truth for Training Set Was Established:

• How Ground Truth Was Established: N/A. As there is no training set, this is not applicable.

Conclusion:

This 510(k) submission for the Stimulation/Dissection Instruments is a substantial equivalence submission, a common pathway for medical devices. It does not present a performance study with explicit acceptance criteria or a test set. Instead, it successfully argues that the new device is as safe and effective as a legally marketed predicate device by demonstrating that its design, technology, features, function, and intended use are substantially equivalent. The "acceptance criteria" are effectively the characteristics of the predicate device that define its safety and effectiveness, which the new device is shown to share.

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