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The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of numerical acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy for the overall system. Instead, it states that:

"All design, process, and other verification and validation testing, which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria was established in support of device performance, and testing demonstrated substantial equivalence of the system to the predicate device."

This indicates that the acceptance criteria were qualitative and focused on demonstrated compliance with pre-established specifications and substantial equivalence to the predicate device.

The "Performance Testing" section lists the types of tests performed:

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

The document specifies "Bench and cadaveric testing was conducted" and includes "Cadaver Study" as a test type. However, it does not provide any details on the sample size (number of cadavers or specific test scenarios) used for the cadaver study or any other test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states: "Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution." While this indicates physician involvement in the design and review process, it does not specify the number of experts used to establish ground truth for a test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance. The system is described as a "surgical instrument to assist in pre-operative planning and/or in guiding..." which implies human-in-the-loop, but no comparative study to measure assistance effectiveness is detailed in this summary.

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

The document does not explicitly state if a standalone (algorithm only) performance study was conducted. The description of the system's outputs ("patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs)") suggests that the system generates these outputs, which are then reviewed by a physician.

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

The document implies that the ground truth for the system's performance, particularly in the cadaver study, would be based on direct observation of surgical guidance and accuracy against the pre-operative plan. Since the system assists in planning and guiding, the "ground truth" would likely be the surgical outcome or accuracy of instrument placement as verified in the cadaveric setting. However, the exact nature of this "ground truth" and how it was established is not detailed. It mentions "physician input" and "reviewed by the physician," suggesting expert judgment forms a basis, but not explicitly as a ground truth for a test set.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This summary focuses on verification and validation testing, not the development or training of an AI component, if one exists within the system's planning features.

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

Since no information on a training set is provided, there is also no information on how its ground truth was established.

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The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.

Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use.

This device is intended for single use only.

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY ™ Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models may also be provided.

The provided text describes the FIREFLY™ Pedicle Screw Navigation Guide and its performance data. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information on ground truth establishment, expert consensus, or MRMC studies. The document is a 510(k) summary for FDA clearance, which typically presents a high-level overview rather than detailed scientific study breakdowns.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical or qualitative acceptance criteria for accuracy and sterilization stability are not detailed in this document.

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

The document mentions "Cadaveric accuracy and sterilization stability testing."

• Sample Size for Test Set: Not specified.
• Data Provenance: Cadaveric testing. (Country of origin is not specified, and it's a prospective study as it was performed for this specific device).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes accuracy testing, but not a comparison of human readers with and without AI assistance to measure improvement effect size.

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

The device is a "Pedicle Screw Navigation Guide," which implies it is a physical guide used by a surgeon during surgery. It is not an AI algorithm in the traditional sense that would have "standalone" performance independent of human interaction in the operating room. Therefore, the concept of "standalone algorithm performance" as typically applied to AI image analysis is not relevant here. The accuracy refers to the guide's precision in directing the surgical instruments.

7. The Type of Ground Truth Used

• Ground Truth: For accuracy, the "ground truth" would likely be the actual placement of the pilot holes or screws in the cadavers, as measured post-procedure (e.g., via CT scanning and comparison to pre-operative plans). This is implied by the term "accuracy testing," but the specific method of establishing this ground truth (e.g., using a gold-standard imaging technique and detailed measurements) is not specified.

8. The Sample Size for the Training Set

The device is a physical navigation guide, not a machine learning algorithm that requires a "training set" in the computational sense. The planning software uses patient CT images, but these are for individual patient planning, not for training a generalized model. Therefore, this question is not applicable.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The document states: "Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY Pedicle Screw Navigation Guide performance is adequate to perform as intended."

This indicates that an experimental study was conducted using cadaveric specimens to evaluate the precision of the guide in directing surgical instruments and to confirm its sterility after processing. However, the details of these studies, including specific methodologies, data collected, statistical analyses, and the actual numerical results against defined acceptance criteria, are not provided in this 510(k) summary.

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