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The Santis Pedicle Screw System is intended for immobilization of the spine. The Santis Pedicle Screw System is indicated for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Santis™ Pedicle Screw System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis™ Pedicle Screw System can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.

This document describes a 510(k) premarket notification for the Santis™ Pedicle Screw System. The primary purpose of this submission is to gain clearance for previously cleared devices as sterile, packaged products. The device is a Class III Pedicle Screw Spinal System.

Here's an analysis of the provided text in relation to acceptance criteria and the study that proves the device meets the criteria:

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

Detailed Explanation of Performance (as per the document):

The performance testing listed above primarily focuses on the packaging and sterilization processes of the device, rather than the clinical performance of the pedicle screw system itself. This is because the submission's purpose is "to gain clearance of previously cleared devices as sterile, packaged products" (page 3). The core device (Santis™ Pedicle Screw System) was presumably cleared in a previous 510(k) (K133063), and this submission addresses the new aspects of packaging and sterilization.

The technical characteristics of the subject device (Santis™ Pedicle Screw System) are stated to be the "Same as predicate" for:

• Indications for Use
• Surgical Technique
• Screw Options and sizes
• Cross Connectors
• Rod sizes
• Materials

This indicates that no new performance studies related to clinical efficacy or safety of the pedicle screw's function (e.g., bone fixation strength, fatigue life under physiological loads) were necessary, as these aspects were already established for the predicate device. The performance criteria here are entirely focused on demonstrating that the sterilization and packaging of the device maintain its safety and effectiveness.

2. Sample sizes used for the test set and the data provenance:

The document does not specify sample sizes for the individual tests (package integrity, sterilization, shelf life, shipping validation). These types of tests typically involve a defined number of samples to statistically demonstrate compliance with the standards, but the exact numbers are not provided in this summary.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, given that these are laboratory validation tests for manufacturing processes (sterilization, packaging), they would be conducted in a controlled environment, likely at the manufacturer's facility or a certified testing lab.

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

This information is not applicable to the type of studies described. The "ground truth" for package integrity, sterilization, shelf life, and shipping validation is established by adherence to recognized international and national standards (ASTM, ANSI/AAMI/ISO). The tests involve objective measurements and established protocols to determine if the device meets these pre-defined standards, not subjective expert assessment of clinical outcomes or images.

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

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data (e.g., reading medical images) to resolve discrepancies among experts. The tests performed here are objective laboratory evaluations against published standards.

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:

This is not applicable. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool. MRMC studies and the concept of "human readers improve with AI" are not relevant to this type of medical device submission.

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

This is not applicable. The device is a physical pedicle screw system, not an algorithm.

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

The "ground truth" for the tests performed (package integrity, sterilization, shelf life, shipping validation) is defined by the specific requirements and acceptance criteria outlined in the referenced technical standards (e.g., ASTM F1886-09, ANSI/AAMI/ISO 11137). These standards describe validated methods and numerical or qualitative criteria for determining compliance. For example, a sterilization validation would involve demonstrating a sterility assurance level (SAL) of $10^{-6}$ in accordance with ISO 11137.

8. The sample size for the training set:

This is not applicable. There is no training set for a pedicle screw system. Training sets are typically used in machine learning or AI development.

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

This is not applicable, as there is no training set.

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The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Santis Pedicle Screws Spinal Fixation is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis system can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Santis Pedicle Screw System, presented in the requested format:

Acceptance Criteria and Study Analysis for Santis Pedicle Screw System (K133063)

Important Note: The provided document is a 510(k) Summary for a medical device (pedicle screw system), which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission usually relies heavily on mechanical testing rather than clinical efficacy studies, especially for Class III devices that are well-understood. Therefore, the "study" referred to here is pre-clinical mechanical testing, not a clinical trial with human subjects/data, or an AI-based performance study. The questions regarding human readers, ground truth for training/test sets, and AI-specific metrics are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, the "acceptance criteria" are typically defined by the performance standards outlined in relevant ASTM test methods. The "reported device performance" is a statement of compliance with these standards, indicating the device met or exceeded the requirements.

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

• Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical data. For mechanical testing, the sample size refers to the number of individual components or assembled constructs tested for each specific condition. This detail is typically provided within the full test reports, which are not part of the 510(k) summary but would have been submitted to the FDA. However, ASTM standards usually specify minimum sample sizes for each test.
• Data Provenance: The data is generated from in vitro mechanical testing of the device components and assemblies. It is not derived from human patients or a specific country of origin in the way clinical data would be. It's pre-clinical, laboratory-generated test data.

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

• Not Applicable. This is not a study assessing diagnostic accuracy or human interpretation against a "ground truth" established by experts. The "ground truth" for mechanical performance is defined by the ASTM standards and the physical properties of the materials and design. The interpretation of the test results against the acceptance criteria is performed by qualified engineers/scientists conducting the tests and preparing the reports.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data. This is mechanical testing, where the results are quantifiable measurements compared against predefined thresholds in the ASTM standards.

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

• No. An MRMC study is a type of clinical comparative effectiveness study, typically used to compare the diagnostic performance of different methods (e.g., human readers with and without AI assistance). This submission is for a pedicle screw system, which is a physical implant, and relies on pre-clinical mechanical testing and comparison to a predicate device, not diagnostic imaging.

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

• Not Applicable. This device is a physical pedicle screw system, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is irrelevant.

7. The Type of Ground Truth Used

• Standardized Mechanical Performance Metrics. The "ground truth" or reference for the device's performance is established by the specified ASTM standards (e.g., F1717-10, F1798-97, F543-07). These standards define the test methodologies, failure criteria, and acceptable performance ranges for pedicle screw systems. Essentially, the "ground truth" is whether the device can withstand the forces and conditions defined by these rigorous engineering standards.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing process are informed by engineering principles, material science, and previous product designs, but this isn't "training data" in the AI sense.

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

• Not Applicable. As there is no training set as understood in AI/clinical studies, there is no ground truth established for it. The development process for such a device is governed by engineering design principles, material standards, and iterative testing, not by a "ground truth" in the AI context.

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