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MySpine MC and Drill Pilot

MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

• Drill based

· K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.

MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.

MySpine Unilateral Guides are a line extension to Medacta's MySpine pedicle and sacro-iliac screw placement guides. Identically to the other Medacta MySpine products, the subject guides are single use, patient matched, pedicle targeted technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine Unilateral Guides have been designed starting from the correspondent bilateral guides which have been modified to allow the drilling of only the left or the right side of vertebra/sacrum through the left or right tube.

Identically to the predicate devices, MySpine Unilateral Guides are manufactured from medical grade nylon for sintering and they can be provided in both non-sterile and sterile version.

This document describes the MySpine Unilateral Guides, a line extension of previously cleared Medacta MySpine pedicle and sacro-iliac screw placement guides. The device is intended to assist in the placement of pedicle screws in the thoracic, lumbar, and sacral spine for fusion procedures.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the typical format of a clinical study. Instead, it describes a "design validation workshop" and a "MySpine Unilateral Guides optional design features rationale" as evidence of performance.

Based on the information, the implicit acceptance criteria are related to the device's ability to maintain existing performance standards despite the design modification (unilateral guides).

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

The document does not provide a specific sample size for a "test set" in the context of a formal clinical or analytical study with defined cohorts. The performance data section primarily refers to:

• "Design validation workshop": The sample size for this workshop (e.g., number of guides tested, number of simulated cases) is not specified.
• "MySpine Unilateral Guides optional design features rationale": This appears to be a theoretical analysis or internal testing, and no sample size is mentioned.

The data provenance is retrospective/internal testing as it refers to a design validation workshop and rationale, not a prospective study on patient data. No country of origin for specific test data is mentioned, but the submitter is Medacta International SA (Switzerland), with the correspondent in the USA.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the "design validation workshop." The context suggests that the "experts" would likely be engineers, surgeons, or other professionals involved in the device's design and testing.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the "test set" (design validation workshop).

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical guide, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results with and without AI assistance. The document explicitly states: "No clinical studies were conducted."

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

This question is not applicable. The MySpine Unilateral Guides are physical surgical guides, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the design validation appears to be based on:

• Engineering specifications/design requirements: Ensuring the guides perform as intended (e.g., maintain accuracy, stability, and guidance parameters).
• Comparison to predicate device performance: The claim of substantial equivalence relies on demonstrating that the new design does not introduce new safety or effectiveness issues compared to already cleared predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The MySpine Unilateral Guides are physical surgical guides and do not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable as there is no "training set" for this device.

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MySpine is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of pedicle screws in the vertebral body. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw placement guides are intended for single use only.

MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: Drill based and K-wire based. MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only.

MySpine S2-Alar/Alar-Iliac is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine S2-Alan/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides are the same of the predicate devices cleared within K200792, K173472 and K153273. Based on the predicate, different screw placement guide configurations are object of this submission, specifically: MySpine Low Profile Guides: for K-wire guidance with conventional screw trajectory; MySpine Drill Pilot Guides: guidance for pedicle path preparation with conventional screw trajectory; MySpine MC/S1 Guides: Drill Pilot and K-wire guidance with cortical bone path; MySpine S2-Alar/Alar Iliac Guides: Drill Pilot guidance with cortical bone path. The MySpine Pedicle Screw Placement Guides are for use in spinal levels T1-S2/S2AI and ilium. The MySpine Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle screws based on the patient's anatomy. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Pedicle Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version. The purpose of this submission is to obtain clearance of the MySpine Pedicle Screw Placement Guides for use with any compatible 510(k) cleared pedicle screw system.

The provided text focuses on regulatory approval (510(k) submission) for MySpine Pedicle Screw Placement Guides Extension and does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or comparative effectiveness with AI assistance.

The document states:

• "The subject devices are the same of the predicate devices (K200792, K173472 and K153273); therefore: no additional testing was required to support this 510(k)."
• "No clinical studies were conducted for the predicate (K200792, K173472 and K153273) nor for the subject devices."

Therefore, I cannot provide the requested information from the given text. The text explicitly mentions that no additional testing or clinical studies were conducted for this 510(k) submission as the devices are considered the same as previously cleared predicate devices, with only a change in indication for use.

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MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identical to the other Medacta MySpine products, the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System (K12115, K132878, K141988, K153664, K162061, and K171170). Specifically, the subject MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

The provided text describes a medical device, the "MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides," and its substantial equivalence determination by the FDA. However, the document does NOT contain information about specific acceptance criteria for a device's performance (like sensitivity, specificity, accuracy, etc.) nor does it usually detail specific studies that prove the device meets such criteria in terms of quantitative metrics suitable for the requested table.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics (manufacturing process, material, biocompatibility, device usage, sterility, shelf life, packaging) and performance data from non-clinical studies (software validation, cadaver testing, guide accuracy, stability assessment). The "guide accuracy" mentioned is a general category and not a specific set of acceptance criteria with reported performance.

Therefore, I cannot fill in the table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, expert qualifications, or ground truth establishment for a standalone algorithm performance study, because this information is not present in the provided text. The document explicitly states: "No clinical studies were conducted." and it does not describe an AI algorithm with human-in-the-loop performance.

Here's an overview of what can be extracted or inferred based on the provided text, and where information is missing:

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

• Acceptance Criteria: Not explicitly stated with quantifiable metrics (e.g., "accuracy must be > 95%"). The document talks about "software validation," "cadaver testing," "guide accuracy," and "stability assessment" as general categories of testing performed, aiming to show safety and effectiveness comparable to the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy percentages, error margins) are reported in the document.

Therefore, this table cannot be filled based on the provided input.

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

• Test Set Sample Size: Not specified. The document mentions "Cadaver testing" and "Guide accuracy" testing, but no details on the number of cadavers or cases used for these tests are provided.
• Data Provenance: Not specified.

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 as no detailed test set and ground truth establishment methodology is described in the provided text. The document refers to "surgical planning software" that "pre-operatively plans the positions of the components based upon radiological images," but this is part of the device's function, not a ground truth establishment for an AI algorithm's performance evaluation.

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

• Not applicable as no detailed test set and ground truth establishment methodology is described.

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. The document explicitly states: "No clinical studies were conducted." The device (surgical guides) assists surgeons, but the documentation does not describe a study involving human readers and AI assistance.

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

• The device is a physical surgical guide produced using software, not a standalone AI algorithm that provides diagnostic or prognostic outputs. The "MySpine software platform" is integral to creating the guides. "Software validation" was performed, but no standalone algorithm performance as typically understood in AI/ML context (e.g., measuring diagnostic accuracy against ground truth without human intervention) is described.

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

• Not explicitly stated for any performance evaluation in terms of AI. For the device itself and its intended use, the anatomical landmarks from patient CT scans and selected surgical equipment (per planning software) would form the basis for the design of the patient-specific guides. The "guide accuracy" testing would presumably involve comparing the guide's output (screw trajectory) against the planned trajectory or anatomical reality, but the specific ground truth methodology for this testing is not detailed.

8. The sample size for the training set

• Not applicable. The document describes a medical device (surgical guides) and the software that creates them for individual patients. It does not refer to a machine learning model that requires a "training set" in the conventional sense for AI performance. The software uses patient-specific CT data for planning.

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

• Not applicable, as there is no mention of a "training set" for an AI model.

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The FIREFLY® Midline Navigation Guide can be used with any 510(k) clearly marketed, pedicle screw spinal system (for its cleared indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures (T10-S2) intended for fusion, with the additions listed below:

• o Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• . Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Midline Screw Navigation Guide
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used with the FIREFLY® Midline Navigation O Guide to confirm pedicle integrity
  • All other pedicle screw spinal system components and accessories [including non-guided taps] are to be O used, after removal of the FIREFLY® Midline Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

The FIREFLY® Midline Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient.

The FIREFLY® Midline Navigation Guide uses Patient-Specific 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 Surgical Plan.

Patient-Specific Bone Models are also provided.

Here's a breakdown of the acceptance criteria and study information for the FIREFLY® Midline Navigation Guide, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size Used for Test Set: Not specified. The document only mentions "Cadaveric accuracy testing."
• Data Provenance: Cadaveric. The document does not specify the country of origin or if the cadavers were retrospectively or prospectively selected.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not specified. The document does not mention the involvement of experts in establishing ground truth for the cadaveric accuracy testing. It's likely that the ground truth for pedicle screw placement in cadaveric studies is often established by comparing the guided placement to anatomical landmarks or established safe zones, which may involve expert anatomical assessment, but the details are not provided.

4. Adjudication Method (Test Set)

Not specified. No information is provided regarding any adjudication method used for the cadaveric accuracy testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device is a "Navigation Guide," implying it assists in physical placement rather than image interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

Yes. The "Cadaveric accuracy testing" appears to be a standalone performance study of the device's ability to guide instruments accurately, without human-in-the-loop performance being assessed in a comparative manner with human readers. The device guides the surgeon to create pilot holes, meaning its performance is inherently linked to its interaction with a surgeon, but the "accuracy testing" usually refers to the precision of the guide itself.

7. Type of Ground Truth Used

The type of ground truth used for the cadaveric accuracy testing is implicitly anatomical/physical measurement. The device guides instrument placement, and "accuracy testing" in this context would likely involve measuring the deviation of the guided trajectories from the presurgically planned trajectories or known correct anatomical paths within the cadaveric pedicles.

8. Sample Size for Training Set

The document does not mention a training set. The FIREFLY® Midline Navigation Guide uses "Patient-Specific Guides" based on "the patient's CT imaging data" and "trajectories chosen presurgically, by the surgeon." This suggests a patient-specific design approach rather than a machine learning model that requires a large training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set for an AI/machine learning model is described. The device's operation is based on pre-surgical planning by a surgeon using patient CT data, not on a trained algorithm.

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The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below:

• . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion ●
• Pedicle screw is intended to be inserted into a pilot hole ●
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
  • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes
  • All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O 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 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 510(k) summary for the FIREFLY® Pedicle Screw Navigation Guide (K181399). Based on the text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document simply states "Additional cadaveric accuracy testing" was performed. It does not specify the number of cadavers or pedicles used in this test set.
• Data Provenance: The study was "cadaveric accuracy testing," implying it was conducted on human cadavers. The country of origin and whether it was retrospective or prospective are not mentioned.

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

This information is not provided in the document. The text does not describe how ground truth was established for the cadaveric accuracy testing, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance.
• Effect size: Not applicable, as no such study is described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The FIREFLY® Pedicle Screw Navigation Guide is a physical device intended to guide surgical instruments. It is not an AI algorithm in the traditional sense that would have "standalone" performance without human-in-the-loop. The "performance data" section refers to cadaveric accuracy testing of the physical guide's ability to direct instrument placement, which inherently involves human surgeons using the device.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the cadaveric accuracy testing. For such a device, ground truth would typically be established by precise measurements of actual screw placement in relation to planned trajectories, possibly using highly accurate imaging techniques (e.g., post-operative CT scans with fiducial markers, or direct anatomical measurements). However, the specific method is not detailed.

8. Sample Size for the Training Set

The document states, "The FIREFLY® 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." This indicates that each guide is patient-specific and generated from individual patient CT data. There isn't a "training set" in the conventional machine learning sense for the device itself, as it's a patient-specific physical guide based on pre-operative imaging rather than a learned algorithm trained on a large dataset.

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

As explained above, there isn't a traditional "training set" for an AI algorithm here. The "training" for the patient-specific guide comes from the individual patient's CT imaging data and the surgeon's presurgical planning. The "ground truth" for this process would be the surgeon's intended screw trajectory based on their anatomical assessment from the CT.

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MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

• Drill based
• K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine MC and Drill Pilot guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.

The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.

The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.

The provided document is a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria or performance data for an AI-powered device. The MySpine system described is a patient-matched surgical guide system that uses pre-operative CT scans to create 3D models and fabricate patient-specific guides. It utilizes software for planning, but it is not an AI/ML-driven device as understood in the context of diagnostic or prognostic AI.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The document primarily focuses on the physical design, manufacturing process, materials, and intended use of the surgical guides, along with non-clinical performance tests relevant to mechanical and design validation, and a statement that no clinical studies were conducted for this particular submission.

To answer your request, if this were an AI or ML-enabled device, the information would typically include:

1. A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc., along with the target thresholds (acceptance criteria) and the actual performance achieved.
2. Sample size used for the test set and the data provenance: Number of cases/patients in the test set, and details like country of origin, whether it was retrospective or prospective data, etc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For example, 3 radiologists with 5+ years of experience each.
4. Adjudication method for the test set: How disagreements among experts establishing ground truth were resolved (e.g., 2+1 means 2 experts agree, if not, a 3rd expert adjudicates; 3+1 means 3 experts agree, if not, a 4th adjudicates).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Details on the study design and the effect size (e.g., human readers improved AUC by X with AI assistance).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The results of the algorithm's performance without human intervention.
7. The type of ground truth used: For instance, expert consensus, pathology reports, clinical outcomes data, follow-up imaging, etc.
8. The sample size for the training set: Number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but often less stringent or by different methods depending on the training methodology.

Since the provided document does not pertain to an AI/ML device, I am unable to provide the specific details requested. The "Performance Data" section (page 7) lists only non-clinical studies related to design validation, stability, post-operative evaluation (accuracy of the physical guide), and wear tests for the physical instruments. It explicitly states "no clinical studies were conducted."

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The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/ilium) intended for fusion, with the additional conditions listed below:

• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion ●
• Pedicle screw is intended to be inserted into a pilot hole ●
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide .
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
  • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be 0 guided to tap pilot holes
  • All other pedicle screw spinal system components and accessories lincluding non-quided faps) are to be O 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 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 purpose of this traditional 510(k) is to expand the FIREFLY® indications for use to allow compatibility with all pedicle screw systems (for their cleared indications for use) meeting certain criteria and use at an additional spinal level. The FIREFLY® design is the same as was originally cleared in K143222.

The provided document, K162419, describes the substantial equivalence determination for the "FIREFLY® Pedicle Screw Navigation Guide". While it mentions that "Additional cadaveric accuracy 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's performance is adequate to perform as intended," it does not fully detail the acceptance criteria or the specifics of the study in a manner that allows for a comprehensive answer to all parts of your request.

Here's an attempt to answer based on the available information, noting where details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document states that acceptance criteria were met but does not explicitly list the specific quantitative acceptance criteria. It only generally refers to "accuracy."

Reported Device Performance: The document states that "Additional cadaveric accuracy testing... demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended." Specific performance metrics (e.g., mean angular deviation, mean translational error) are not provided in this document.

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

• Sample Size for Test Set: The document simply mentions "Additional cadaveric accuracy testing" without specifying the number of cadavers, pedicles, or screws tested.
• Data Provenance: "Cadaveric accuracy testing" implies the data was derived from cadaveric studies. The country of origin is not specified but given the FDA submission, it's likely a study conducted in the USA or adhering to US standards. It's inherently a retrospective analysis of the device's accuracy on cadaveric specimens.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the cadaveric study. For cadaveric studies involving pedicle screws, ground truth often involves post-operative CT scans or direct measurement by skilled researchers/surgeons.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. This type of study is more common for diagnostic imaging AI systems to assess human performance with and without AI assistance. This device is a surgical navigation guide.

6. Standalone (Algorithm Only) Performance Study

The document describes "accuracy testing," which is inherently a standalone performance evaluation of the device as it guides surgical instruments. However, the exact methodology and quantitative results for this standalone performance are not provided beyond the statement that acceptance criteria were met.

7. Type of Ground Truth Used

For "cadaveric accuracy testing," the ground truth typically involves:

• Post-operative imaging: High-resolution CT scans of the cadaveric spine with inserted pedicle screws, where the actual position of the screws relative to the pedicle canal is measured.
• Direct measurement: Physical dissection and measurement, though less common for pedicle screw accuracy compared to imaging.

The document does not explicitly state how the ground truth was established, but the context of pedicle screw accuracy testing points to methods that objectively verify screw placement against anatomical goals.

8. Sample Size for the Training Set

The document describes a "Pedicle Screw Navigation Guide," which is a mechanical guidance device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense. The device's design is based on patient-specific CT imaging for pre-surgical planning, but this is a process of individual case design, not an algorithm being "trained" on a large dataset. Therefore, the concept of a training set sample size is not applicable here.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of mechanical surgical navigation guide.

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