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Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

• Sierra Summit console base unit with integrated control panel ●
• Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
• Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
• Display monitor ●
• Summit software

The Sierra Summit has the following optional accessories/components:

• Remote Head Box (for 3-12 channel amplifier) ●
• StimTroller (Hand Held Electrical Stimulator)
• Electrical Stimulator Switch Box ●
• Footswitch (single) ●
• Visual Stimulators (LED Goggles, LCD Checks)
• VEP Calibration Sensor
• Headphones or other auditory transducers
• Reflex Hammer
• Temperature Probe ●
• Cart
• Isolation Transformer or Medical Grade Power Strip
• Printer

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

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):

This information is not provided in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document. There is no mention of an adjudication method.

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:

This information is not provided in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

9. How the ground truth for the training set was established:

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• . spinal stenosis.
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or
• . spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document describes a 510(k) premarket notification for the Sierra™ spinal system, specifically referring to the addition of rod connectors, crossbars, and set screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or safety. Therefore, the provided information does not include details on acceptance criteria, a study proving performance against those criteria, or specific metrics like sensitivity, specificity, or reader improvement with AI.

Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics in the provided document. For 510(k) submissions, the “acceptance criteria” typically revolve around demonstrating substantial equivalence in terms of functionality, technological characteristics, and safety to a predicate device. This is often achieved through comparative testing (e.g., mechanical, material) and analysis rather than clinical performance metrics.
• Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the new components have "substantially equivalent technological characteristics to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable/not provided. This document does not describe a clinical study in the traditional sense involving a "test set" of patients or data for performance evaluation. The "testing" likely involved mechanical and material characterization of the new components against established standards or predicate device specifications.
• Data Provenance: Not applicable/not provided.

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 applicable/not provided. Ground truth establishment by medical experts is typically part of clinical performance studies, which are not detailed in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/not provided. Adjudication methods are relevant for clinical studies that involve expert review of cases, which is not the focus of this document.

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

• MRMC Study: No. This document concerns a conventional medical device (spinal fixation system components), not an AI-powered diagnostic or assistive tool.
• Effect size of human reader improvement with AI: Not applicable, as no AI component is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable, as no algorithm or AI component is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for a 510(k) submission like this would involve demonstrating that the new components meet established engineering and material standards, and perform comparably to predicate devices in mechanical and functional tests. It is not about clinical ground truth derived from patient data.

8. The sample size for the training set

• Not applicable. There is no mention of an algorithm or AI requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. There is no mention of an algorithm or AI requiring a training set or ground truth establishment in this context.

Summary of what the document does provide:

• Predicate Devices: SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
• Basis for Equivalence: "The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices." and "The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
• Materials: All products are fabricated from titanium alloy.
• Intended Use: Promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and spinal tumor).
• Limitations: Occipital bone screws limited to occipital fixation; polyaxial screws limited to T1-T3 for thoracic conditions only, not for cervical spine.

In conclusion, this document is a 510(k) summary for a conventional medical device modification, which focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting clinical study results with performance metrics or AI algorithm validation.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• spinal stenosis, .
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or .
• . spinal tumor.
  The occipital bone screws are limited to occipital fixation only.
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document is a 510(k) premarket notification for the Sierra™ OCT Spinal System, specifically for the addition of a new occipital plate design. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance. Since this is a submission for a Special 510(k) and the information provided points to substantial equivalence with existing predicate devices, the focus is on design and material equivalency, rather than clinical performance studies involving a test set, ground truth, or human-in-the-loop assessments as would be done for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The "acceptance criteria" here refer to satisfying FDA's requirements for substantial equivalence based on design, materials, and intended use.

Here's the breakdown of the information based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable (N/A). This submission is for a medical device (occipital plate) and relies on substantial equivalence to predicate devices, not clinical performance data from a test set of patients in the way an AI/ML device would. No patient data or test set in the traditional sense was used.

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)

• N/A. Ground truth establishment is not relevant for this type of submission, which focuses on engineering and design equivalency.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. No test set or human adjudication process as described is relevant.

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 is not an AI/ML device, so no MRMC study or AI assistance evaluation was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• N/A. The "ground truth" equivalent in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness. The new device is deemed safe and effective because its characteristics are substantially equivalent to those already cleared devices.

8. The sample size for the training set

• N/A. No training set is relevant for this device.

9. How the ground truth for the training set was established

• N/A. No ground truth for a training set was established.

Ask a specific question about this device

The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis, .
• . trauma (i.e., fracture or dislocation),
• . spinal stenosis,
• . atlantoaxial fracture with instability.
• occipitocervical dislocation, .
• . revision of previous cervical spine surgery, and/or
• . spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.

Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use.

The provided document is a 510(k) Pre-Market Notification for the Sierra™ spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study details, ground truth, and training sets are not applicable to this type of regulatory submission. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."

Here's a breakdown of the available information:

Acceptance Criteria and Study Details for Sierra™ Spinal System

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed to establish specific performance metrics or acceptance criteria for clinical outcomes, this cannot be provided as it would for a device relying on de novo clinical data. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported relates to mechanical strength per applicable standards.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No clinical test set or human data was used for this 510(k) submission. The evaluation was based on technological characteristics and mechanical testing.

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 Applicable. No ground truth was established by external experts in the context of clinical performance or diagnostic accuracy. The substantial equivalence argument relies on comparison to existing legally marketed devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No test set requiring adjudication was used.

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 is a medical device (spinal system implants and instruments), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is a medical device, not an algorithm. Therefore, no standalone performance study was conducted.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not Applicable. As no clinical studies were performed, no ground truth based on clinical outcomes or expert consensus for a test set was established. The "ground truth" for the submission is the regulatory acceptance of the predicate devices whose characteristics the Sierra system mimics.

8. The sample size for the training set:

• Not Applicable. No machine learning or AI models were used, so there was no training set.

9. How the ground truth for the training set was established:

• Not Applicable. No machine learning or AI models were used, so there was no training set or ground truth establishment for such.

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