(36 days)
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).
The provided text describes the 510(k) premarket notification for Spineology Navigation Instruments. This document demonstrates the substantial equivalence of the new instruments to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a standalone study.
Therefore, many of the requested details regarding acceptance criteria, device performance, sample size, ground truth, and expert involvement are not applicable as this is a regulatory submission for substantial equivalence based on technological characteristics and non-clinical testing, not a clinical effectiveness study.
Here's what can be extracted from the provided text based on your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a typical clinical study. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on compatibility and accuracy within the context of the Medtronic StealthStation System.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Instrument Mating: Connection between the Medtronic NavLock Tracker Array and Spineology Navigation Instruments is functional. | Testing evaluated the connection, implying successful mating. |
| Registration: Spineology Navigation Instruments can be registered with the Medtronic StealthStation System. | Testing ensured instruments can be registered, implying successful registration. |
| Accuracy: Accuracy equivalent to Medtronic Navigation Instruments when used with the Medtronic StealthStation System. | Side-by-side comparison with equivalent Medtronic instruments was performed, implying comparable accuracy. |
| Safety and Effectiveness: No new issues of safety or effectiveness are introduced compared to the predicate device. | Risk assessment conducted to confirm no new issues. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of numerical count for instruments or specific test scenarios. The non-clinical testing generally refers to "Spineology Navigation Instruments."
- Data Provenance: The "Non-Clinical Testing" section describes in-house design verification activities performed by Spineology Inc. No specific country of origin for data is mentioned, and the testing is described as internal verification rather than external data collection. The tests are retrospective in the sense that they are internal design verification activities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for non-clinical engineering tests (like instrument mating, registration, and accuracy) is typically established by engineering specifications, validated measurement systems, and comparison to known good standards or predicate device performance, not by clinical experts establishing ground truth in the way it's done for diagnostic AI. The document does not mention external experts or their qualifications for establishing ground truth in these non-clinical tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described (instrument mating, registration, accuracy comparison) would involve objective measurements and comparisons against established metrics or predicate device performance, not clinical adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of surgical navigation instruments, not an AI-assisted diagnostic or interpretative device. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device (Spineology Navigation Instruments) is a physical surgical instrument intended for use with the Medtronic StealthStation System and by a surgeon (human-in-the-loop). It is not an algorithm that operates in a standalone capacity.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" would be based on:
- Engineering Specifications: For instrument mating and registration, the "ground truth" is that the instruments must correctly connect and register according to pre-defined engineering standards for the Medtronic StealthStation System.
- Predicate Device Performance: For accuracy, the "ground truth" is the established accuracy of the equivalent Medtronic Navigation Instruments, to which the new Spineology instruments were compared.
- This is not clinical ground truth like pathology or outcomes data.
- For the non-clinical tests described, the "ground truth" would be based on:
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The sample size for the training set:
- This information is not applicable. There is no mention of a "training set" because this device is a physical instrument, not an AI or machine learning model that requires training data.
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How the ground truth for the training set was established:
- This information is not applicable as there is no training set mentioned or implied for this device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).