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The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.

The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

This device, the SATELLITE™ Spinal System (K051320), received 510(k) clearance in 2005. It's important to note that the provided documentation states this device is a "preamendment device" and was found substantially equivalent to a legally recognized preamendment device (the Harmon Spinal Sphere). This means that its acceptance criteria and the "study" that proves it meets them are fundamentally different from what would be expected for a novel device undergoing a PMA (Premarket Approval) process under current regulations.

The core of its "acceptance" is substantial equivalence to a predicate device that was on the market before the 1976 Medical Device Amendments. Therefore, the information requested about specific performance metrics, sample sizes, expert ground truth, etc., in the context of a prospective study for a novel device does not apply in the same way to this 510(k) clearance.

Here's an attempt to answer the questions based on the provided document, highlighting where the typical interpretation of these questions doesn't fit a preamendment predicate equivalence pathway:

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

For a 510(k) clearance based on substantial equivalence to a preamendment device, the "acceptance criteria" are primarily established by the characteristics and intended use of the predicate device. The "reported device performance" is demonstrating that the new device shares similar characteristics and performs as safely and effectively as the predicate for its intended use, based on documentation and engineering principles rather than a detailed clinical performance study against specific quantitative criteria.

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 applicable in the context of a 510(k) clearance based on substantial equivalence to a preamendment device like the SATELLITE™ Spinal System. There was no "test set" in the sense of a clinical study with a specified sample size. The clearance was based on comparison to an already marketed predicate, not new clinical data demonstrating specific performance metrics against a defined acceptance criteria.

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 applicable. There was no "test set" requiring ground truth establishment by experts for performance evaluation in a clinical study. The FDA's review for substantial equivalence focuses on comparing the new device's design, materials, and intended use to the predicate.

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

This information is not applicable for the reasons stated above.

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 applicable. The SATELLITE™ Spinal System is a physical implant, not an AI or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.

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

This information is not applicable as the device is a physical implant, not an algorithm.

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

This information is not applicable in the context of establishing performance for this 510(k) clearance. The "ground truth" for the clearance was essentially the FDA's acceptance that the predicate device (Harmon Spinal Sphere) was legally marketed and considered safe and effective for its intended use, and that the SATELLITE™ Spinal System was sufficiently similar.

8. The sample size for the training set

This information is not applicable. There was no "training set" as this device is a physical implant and not an algorithm requiring machine learning.

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

This information is not applicable as there was no training set.

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The Satellite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.

The Satellite is a portable, battery-powered, digital electroencephalographic (EEG) data recorder that is designed to be carried in a hip belt worn by the patient. The intended use of this device is to record the patient's EBG while the patient is ambulatory or at home. Recorded EEG data is stored in a removable hard disk drive, which the medical practitioner can then remove from the data recorder and connect to a standard personal computer. The personal computer is then used to review and analyze the EEG data, generate reports, and provide longer-term storage for the EEG data. The personal computer also performs various system utility functions on the data recorder, such as programming the user-selectable parameters, and measuring the electrical impedance of the EEG electrode connections. A battery pack and charger also accompany the data recorder. These items are designed so the battery pack cannot be recharged while it is powering the data recorder, so the data recorder (which may be attached to the patient) cannot be connected to the AC-powered charger. The device is intended to complement Nicolet's existing line of EEG systems, including the Voyageur digital EEG system (K921927B) and BMSI long-term EEG monitoring system (K891405A). Neither of these devices currently provides the capability for ambulatory or athome EEG data recording, however, both will record and playback EEG data that is similar to the data recorded by the Satellite.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nicolet Satellite device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "sensitivity > X", "specificity > Y", "accuracy > Z%"). Instead, the acceptance criteria are implicitly defined by the claim of substantial equivalence to predicate devices. The performance is reported in qualitative terms relating to this equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Non-Clinical Tests: Not explicitly stated as a number. The text mentions "EEG test data derived from actual human EEG recordings, and included examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." This implies a set of diverse, pre-recorded human EEG data but doesn't quantify the number of cases or recordings.
• Sample Size for Clinical Tests: Not explicitly stated. The text notes that "clinical tests were performed to solicit comments from actual users and to assess the performance of the device under actual-use conditions." This suggests a qualitative assessment with an unspecified number of users/patients.
• Data Provenance: The text does not specify the country of origin. The test data for non-clinical evaluation was "derived from actual human EEG recordings." For clinical tests, the data was from "actual-use conditions," implying real patients. Both appear to be prospective data collection (for the specific purpose of testing the Satellite), but for the non-clinical tests, the "actual human EEG recordings" could have been retrospective archival data used prospectively for testing. However, this is not clarified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The summary states that the device is "intended to involve competent human intervention" and that "clinical judgment and experience must be used to check and interpret the system's output." This implies that the 'ground truth' for evaluating the device's ability to record and present data for seizure, spike, and waveform identification would ultimately be based on the interpretation of qualified medical professionals (e.g., neurologists or neurologists specializing in electrophysiology), but this is not explicitly stated as how ground truth was established for the specific test set.

4. Adjudication Method for the Test Set

Not specified. Given the nature of the device (a data recorder, not an interpretive AI), direct adjudication methods like 2+1 or 3+1 typically used for diagnostic interpretations are less relevant. The evaluation focused on the device's ability to faithfully record various EEG phenomena for subsequent human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not conducted. The comparison was primarily against the specifications and characteristics of predicate devices, not through a direct comparative study with human readers using or not using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

Yes, in essence. The primary evaluation described is a standalone performance test of the device as an EEG data recorder. The device records data, and its performance is judged on its ability to capture and store that data accurately, making it available for human review. It is explicitly stated that the device "is intended to involve competent human intervention before any impact on human health occurs (i.e., clinical judgment and experience must be used to check and interpret the system's output)." This confirms that the device itself is not providing a diagnosis or interpretation algorithm that would be judged in a standalone fashion against a ground truth diagnosis. Its "performance" is its ability to record and present the data.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on expert consensus/identification within the "actual human EEG recordings". The test data included "examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." The 'ground truth' here is the presence of these known phenomena within the source recordings, and the device's ability to accurately capture and represent them. This isn't pathology or outcomes data, but rather a recognized pattern within electrophysiology as interpreted by experts.

8. The Sample Size for the Training Set

Not applicable/provided. The Nicolet Satellite is an EEG data recording device, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its function is to accurately capture analog electrical signals and convert them into a digital format for storage and later review. It does not learn or make diagnostic interpretations.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, the device does not use a training set as it is not an AI/ML system.

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