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The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.

The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

The HOLO Portal™ System is a combination of hardware and software that provides visualization of the patient's internal anatomy and surgical guidance to the surgeon based on patient-specific digital imaging.

HOLO Portal™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The HOLO Portal™ System consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy, compared to traditional two-dimensional (2D), displays during surgical procedures.

The provided text describes the acceptance criteria and the study conducted for the HOLO Portal™ Surgical Guidance System, primarily focusing on performance testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "positional error must be less than X mm"). Instead, the document refers to "worst-case" measurements and relies on clinical meaningfulness relative to the predicate. The performance data is summarized in tables.

Acceptance Criteria Implied: The device must meet "performance requirements under the indications for use" and demonstrate "equivalent safety and efficacy of the system to the cited predicate device." The provided numbers represent the achieved performance, which is presumably within acceptable limits for its intended use and considered substantially equivalent to the predicate. No explicit numerical acceptance thresholds are provided in the text.

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

• Sample Size for Test Set: The document does not explicitly state the number of cadavers or benchtop phantoms used. It mentions "surgical simulations conducted on cadavers" and "rigid benchtop phantoms." It refers to "a set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans" for software validation. The number of measurements (which would be related to the sample size of "pedicle screws" or placements) is not provided.
• Data Provenance: The document does not specify the country of origin for the data. The studies are described as "surgical simulations conducted on cadavers" and "rigid benchtop phantoms," and testing for software validation used "extracted from stationary and intraoperative Computed Tomography scans." It is retrospective in the sense that the CT scans for software segmentation were "extracted," but the practical "performance validation" and "verification" studies appear to be prospective experimental setups (cadaver labs, benchtop testing).

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

• Number of Experts: For the software validation study of anatomical segmentation, the ground truth was established by "manual segmentations prepared by trained analysts." The specific number of analysts is not provided.
• Qualifications of Experts: The experts are simply described as "trained analysts." No specific qualifications (e.g., radiologist, years of experience) are mentioned.

4. Adjudication Method for the Test Set

• For the software validation (segmentation comparison), an adjudication method is not explicitly stated. The comparison was based on "mean Sørensen-Dice coefficient (DSC) calculations" against manual segmentations. This implies a direct quantitative comparison rather than a human-based adjudication process for discrepancies.
• For the positional and angular error measurements in cadaver and benchtop testing, "the 3D (Euclidean) distance between the tips of the virtual and real implants" and "the angle between the 3D trajectories of the virtual and real implants" were measured. This is an objective measurement, not requiring human adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not explicitly mentioned or described in the provided text. The device is a surgical guidance system, not an AI for image interpretation that would typically involve a diagnostic reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, aspects of standalone performance were conducted:

• Positional and Angular Error (Cadaver and Benchtop): These measurements assess the system's accuracy in tracking and guiding, which is a standalone performance metric of the system itself in a controlled environment.
• Software Validation (Segmentation): "A set of test samples presenting lumbosacral spine... was subjected to the autonomous spine segmentation process performed by the HOLO Portal System." The quality was determined by comparing the system's segmentation to manual ground truth. This is a clear example of standalone algorithm performance testing.

7. The Type of Ground Truth Used

• For Positional/Angular Error (Cadaver and Benchtop): The ground truth was based on the "real implants" or "real pedicle screws" placed, with measurements taken relative to these physical realities. This could be considered a form of objective measurement against physical reality.
• For Software Segmentation: The ground truth was "manual segmentations prepared by trained analysts." This is expert consensus/manual annotation based ground truth.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the HOLO Portal™ Surgical Guidance System's software, including the autonomous spine segmentation process.

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

The document does not provide information on how the ground truth for the training set was established. It only describes the establishment of ground truth for the test set (manual segmentations by trained analysts).

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The Cortera" Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondy lolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera" Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera" Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

The Cortera™ Spinal Fixation System is a Thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or the sacral spine. The System consists of screws, rods, locking set screws and associated manual surgical instruments for an open or minimally invasive surgical approach. The screws and set screws are manufacturered from titanium alloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy or cobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants are available in a variety of sizes to accommodate individual patient anatomy and are provided non-sterile.

The Cortera™ Spinal Fixation System rods may be used in connection with Streamline Cross Connectors, covered in K192800. The Streamline Cross Connectors accept various rod diameters and are appropriate for use with Cortera™ Spinal Fixation System 5.5 mm diameter rod-based systems. These cross connectors will keep their original cleared trade name.

The provided document is an FDA 510(k) clearance letter for the Cortera™ Spinal Fixation System. This is a document used to demonstrate the substantial equivalence of a new medical device to a legally marketed predicate device.

Crucially, this document does NOT describe the acceptance criteria or a study that proves a device meets specific performance criteria for an AI/ML algorithm within the context of medical imaging or diagnostics.

The "Performance Data" section (VII) refers to mechanical and physical testing of the spinal fixation system (e.g., static and dynamic compression, torsion, pull-off testing of the screws and rods per ASTM standards). This is typical for orthopedic implant devices to ensure their structural integrity and durability. It does not relate to the performance of an AI model.

Therefore, I cannot extract the information required by your prompt regarding Acceptance Criteria and a study proving an AI/ML device meets them, because this document is about a surgical implant, not an AI/ML medical device.

To answer your prompt, I would need a document detailing the 510(k) or de novo submission for an AI/ML powered medical device, which would include information on its clinical performance studies, ground truth establishment, sample sizes for training and testing, and acceptance criteria for its analytical and clinical validity.

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The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.

The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

The ARAI™ System is a combination of hardware and software that provides visualization of the patient's internal boney anatomy and surgical guidance to the surgeon based on registered patient-specific digital imaging.

ARAI™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The ARAI™ system consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. The 3D scanned data is displayed with both 2D images and 3D virtual models along with tracking information on computer mounted on workstations near the patient bed and a dedicated projection display mounted over the patient. Augmented reality is accomplished with the 3D virtual models being viewed with dedicated headset(s).

Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy.

Here's an analysis of the acceptance criteria and study details for the ARAI™ Surgical Navigation System based on the provided FDA 510(k) summary:

The document does not explicitly present a table of acceptance criteria. Instead, it presents the results of performance validation for positional and angular errors. Therefore, the reported device performance is used directly to infer the implied acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Positional and Angular Error Validation (Surgical Simulations):
  • Sample Size: Not explicitly stated in the provided text. The terms "overall 3D positional error" and "overall 3D angular error" are used, but they do not reveal the number of screws measured or the number of cadavers.
  • Data Provenance: Prospective, real-world simulation using cadavers ("Surgical simulations conducted on cadavers were performed for system validation."). The country of origin is not specified.
• Software Segmentation Quality:
  • Sample Size: A "set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans" was used. The exact number of samples is not provided.
  • Data Provenance: CT scans (both stationary and intraoperative) of the lumbosacral spine. It is unclear if these were retrospective or prospective, or their country of origin.

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

• Positional and Angular Error Validation: The document describes the ground truth as the "real implants." It does not mention experts establishing the ground truth for this measurement directly, as it's a direct comparison between the virtual and physically placed surgical artifacts.
• Software Segmentation Quality: The ground truth was established by "manual segmentations prepared by trained analysts." The number of analysts and their specific qualifications (e.g., years of experience, specific medical specialty) are not provided.

4. Adjudication Method for the Test Set

• Positional and Angular Error Validation: Not applicable, as the ground truth derivation is not a subjective consensus process. It's a measurement against a physical reference.
• Software Segmentation Quality: The ground truth was established by "manual segmentations prepared by trained analysts." The document does not specify an adjudication method (like 2+1 or 3+1) if multiple analysts were involved or if a single analyst's segmentation was considered the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• The provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore does not report an effect size for human readers improving with AI vs. without AI assistance. The performance testing focuses on the device's accuracy in tracking and displaying anatomical structures and instruments.

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

• Yes, a standalone performance assessment of the algorithm appears to have been conducted, particularly for:
  • Positional and Angular Error Validation: This directly quantifies the system's accuracy in representing physical instrument and screw positions relative to the anatomical model, which is an algorithm-driven output.
  • Software Segmentation Quality: The "autonomous spine segmentation process" was compared against manual segmentations, indicating a standalone evaluation of the algorithm's performance in this task.

7. The Type of Ground Truth Used

• Positional and Angular Error Validation: The ground truth was the "real implants" positioned in cadavers. This is a form of direct physical measurement/outcome data.
• Software Segmentation Quality: The ground truth was expert manual segmentation ("manual segmentations prepared by trained analysts").

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set for any of the algorithms (e.g., for spine segmentation or tracking). It only mentions test samples.

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

• The document does not provide information on how the ground truth for the training set was established, as it does not describe the training process or the dataset used for training. It only details the establishment of ground truth for certain test sets.

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