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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools. Do not implant instruments.

The robotic graft delivery instruments are non-sterile re-usable instruments that may be used during the preparation and placement of various graft material during spinal surgery. The subject instruments are made of a medical grade stainless steel commonly used in orthopedic procedures, which meet available national or international standards specifications. The robotic graft delivery instruments are intended to be used when preparing and placing graft material during spinal surgery. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work through the MAZOR X arm guides. The instruments will be provided non-sterile and reusable.

The provided document describes Medtronic's Robotic Graft Delivery Instruments and their 510(k) summary (K230716). However, it does not contain detailed information regarding acceptance criteria, the specific study design to prove acceptance, sample sizes for test/training sets, expert qualifications, or adjudication methods. The document primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices and lists general performance tests conducted.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document describes general performance tests, but explicit acceptance criteria with numerical targets are not provided. The 'Description' column of the performance test table gives an indication of what was confirmed, which implicitly suggests the desired performance.

Implicit Acceptance Criteria and Reported Device Performance

Additional Information on the Study:

• Sample size used for the test set and the data provenance:

  • Sample Size: Not specified in the document.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based ("Anatomical Simulated Use," "Mechanical Guidance Accuracy," "Depth Control Analysis").

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not specified. The document refers to "expected use conditions" and engagement with "facet defect created by Mazor X Stealth Edition facet decortication tools," suggesting a simulated environment rather than human expert reads of clinical images or data for ground truth.

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

  • Not applicable/Not specified. The tests described are functional and mechanical in nature, not involving interpretation by multiple adjudicators.

• 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. The device is a surgical instrument, not an AI-assisted diagnostic tool. This type of study is not relevant to this device.

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

  • Not applicable. The device is a surgical instrument. The performance testing "confirmed instrument functionality under expected use conditions" and "mechanical guidance accuracy," implying standalone functional and mechanical testing of the instrument itself rather than an algorithm.

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

  • The "ground truth" for the performance tests appears to be objective, measurable mechanical and functional standards (e.g., "allowable surgical tool mechanical tolerance," "engage facet defect"). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.

• The sample size for the training set:

  • Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning model that requires a training set.

• How the ground truth for the training set was established:

  • Not applicable, as there is no training set for this type of device.

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