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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.

The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.

The Paradigm System is used with an external monitor.

The provided FDA 510(k) Clearance Letter for the Paradigm System (K250879) indicates substantial equivalence to a predicate device (K243258). While it mentions that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists various standards used in testing, it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

The document primarily focuses on demonstrating substantial equivalence based on the device's intended use, indications for use, fundamental scientific technology, and technical characteristics being the same as the predicate. It states that "Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness," but does not present the granular data of what those performance, safety, and usability tests entailed or their quantitative outcomes against defined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method for the test set: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not specified.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not specified.
9. How the ground truth for the training set was established: Not specified.

The provided document is a 510(k) clearance letter, which summarizes the FDA's finding of substantial equivalence based on information submitted by the manufacturer. It typically does not contain the detailed raw data, study designs, or complete results of every verification and validation test performed by the manufacturer. That detailed information would be found in the manufacturer's submission to the FDA, not in the clearance letter itself.

The document lists standards used, such as ASTM F2554-22 "Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems." This standard likely defines methods for measuring positional accuracy, which would be a key performance metric for a stereotaxic navigation system. However, the document does not report the specific results of applying this standard or the acceptance criteria for those results.

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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.

The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.

The Paradigm System is used with an external monitor.

The provided document is a 510(k) premarket notification acceptance letter from the FDA for the Paradigm System. It primarily discusses the device's substantial equivalence to a predicate device (also named Paradigm System) and lists relevant regulations and testing standards.

Crucially, this document does NOT contain details about the acceptance criteria and the specific study performance that proves the device meets those criteria. It mentions "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists some standards used for testing (e.g., IEC 60601-1, ISO 14971, ASTM F2554-22 for positional accuracy). However, it does not provide the actual quantitative acceptance criteria or the results from these studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. While ASTM F2554-22 (Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems) is mentioned, the specific acceptance thresholds and the measured positional accuracy of the Paradigm System are not detailed.
2. Sample size used for the test set and the data provenance: The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model" but does not specify the sample size (number of cadavers, number of anatomical sites, etc.) or the provenance of the cadavers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the study details are missing.
4. Adjudication method for the test set: Not applicable as the study details are missing.
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 device is a stereotaxic image guidance system, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers. The document does not mention any AI components that would assist human readers in image interpretation. Its function is to guide surgical instruments, fusing real-time camera imaging with medical imagery (CT) and surgical navigation data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a system for surgical guidance, implying a human (surgeon) is always in the loop. It does not mention a standalone algorithm evaluation.
7. The type of ground truth used: For positional accuracy, the ground truth would typically be established by highly accurate measurement systems (e.g., optical tracking systems, CMMs) in a controlled environment, not expert consensus or pathology in the traditional sense of diagnostic AI. The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model," which suggests physical measurements against a known fiducial or planned trajectory.
8. The sample size for the training set: Not applicable, as detailed information on any AI/machine learning components or their training is not provided. The system uses "preoperative imaging segmentation" but doesn't elaborate on whether this involves deep learning requiring a dedicated training set.
9. How the ground truth for the training set was established: Not applicable, as information on training sets is missing.

In summary, the provided FDA letter confirms the clearance of the Paradigm System based on substantial equivalence but does not disclose the detailed performance study results or the specific acceptance criteria met by the device. These details would typically be found in the full 510(k) submission, which is not included here.

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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.

Acceptance Criteria and Study for Paradigm System

The Paradigm System, a stereotaxic image guidance system, underwent verification and validation activities to assure it meets performance requirements. The provided documentation highlights general functional and safety testing as well as cadaveric model studies. This response compiles the stated information regarding acceptance criteria and the supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics for the Paradigm System. Instead, it broadly states that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions." The document lists the types of testing performed and the standards used, implying that the acceptance criteria are met by demonstrating compliance with these tests and standards.

The studies mentioned are:

• Non-Clinical Hardware, Software, and Instrumentation Verification Tests
• Non-Clinical Design Validation conducted in Cadaveric Model
• Cadaveric Simulated Workflow Study Assessing Usability
• Compliance Conformity Assessments

The conclusion states: "Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness." This indicates that the device's performance was deemed acceptable relative to established safety and effectiveness benchmarks, likely derived from the predicate device and relevant standards.

2. Sample Size for Test Set and Data Provenance

The document states that a "Non-Clinical Design Validation conducted in Cadaveric Model" and a "Cadaveric Simulated Workflow Study Assessing Usability" were performed for testing.

• Sample Size: The exact sample size (number of cadavers or specific test cases) used for these cadaveric studies is not specified in the provided text.
• Data Provenance: The cadaveric studies are inherently prospective in their design, as they involve performing procedures on the cadavers in a controlled setting for the purpose of testing. The country of origin of the cadaveric data is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The mention of "Cadaveric Simulated Workflow Study Assessing Usability" suggests involvement of users (e.g., surgeons) in the evaluation, but details on ground truth establishment are absent.

4. Adjudication Method for the Test Set

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

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.

6. Standalone Performance Study

The document refers to "Non-Clinical Hardware, Software, and Instrumentation Verification Tests" and "Non-Clinical Design Validation conducted in Cadaveric Model." While these indicate testing of the algorithm and system, it is not explicitly stated whether a "standalone (i.e., algorithm only without human-in-the-loop performance)" study was conducted. The nature of a stereotaxic image guidance system inherently involves integration with human procedural steps.

7. Type of Ground Truth Used

For the cadaveric studies, the specific type of ground truth used (e.g., expert consensus on target accuracy, direct measurement, pathology, outcomes data) is not explicitly stated. Given the device's purpose for spatial positioning and orientation, ground truth would likely involve highly accurate measurements of instrument tip position relative to anatomical targets within the cadaveric model, verified by a gold standard measurement technique.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for any underlying algorithms within the Paradigm System. The description of the device's principle of operation mentions "fuses high-resolution, real-time camera imaging... with medical imagery (such as CT)" and "Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae," implying that algorithms are trained on such data.

9. How Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established.

In summary, while the document confirms that various tests were conducted to ensure the safety and effectiveness of the Paradigm System, detailed information regarding specific performance metrics, sample sizes for test and training data, expert qualifications, and ground truth establishment methods is largely absent in the provided text.

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