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The S-LOK™ PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The S-LOK™ PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

The S-LOK™ PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws and hooks. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Here's an analysis of the provided text regarding the S-LOK™ PSS Pedicle Screw System's acceptance criteria and studies:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions a "cadaver study" but does not specify the sample size (number of cadavers or specific test subjects).
   • The provenance of the data (country of origin, retrospective/prospective) is not specified.

2. 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):

   • This information is not provided in the document. The studies conducted are mechanical and biomechanical, not clinical studies involving expert interpretation for ground truth.

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

   • Not applicable. The studies are mechanical/biomechanical, not involving human adjudication of results.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a pedicle screw system, not an AI diagnostic tool.

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

   • No, a standalone (algorithm-only) performance study was not done. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests (Static axial gripping, Static flexion/extension moment), the ground truth is derived from the established ASTM F1798 standard and comparison to the predicate device's performance under similar testing conditions.
   • For the cadaver study, the ground truth would be based on biomechanical measurements and observations of the system's performance within the cadaveric spine, again likely in comparison to the predicate device.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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The PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion,

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws and hooks. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, titanium alloy described by such standards as ASTM F-138, ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

This document is a 510(k) premarket notification for the "PSS System," a pedicle screw spinal system. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically seen in studies for novel high-risk devices or AI/ML-driven diagnostics.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) submission. This submission primarily relies on comparing the new device's design, materials, and intended use to existing legally marketed predicate devices.

Here's why and what information is available:

• Type of Device: The PSS System is a pedicle screw spinal system, a mechanical implant.
• Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a predicate device. This pathway typically relies on engineering and performance testing (e.g., mechanical strength, fatigue), material characterization, and comparison of design features and intended use with already cleared devices. It does not usually involve clinical trials to establish sensitivity, specificity, or reader performance improvements.
• Focus of Submission: The conclusion explicitly states: "Based on the results, the overall designs of the PSS System which consists of pedicle screws, rods, cross links, locking cap screws and hooks are substantially equivalent to the predicate devices."

Therefore, the specific questions related to AI/ML device study design, acceptance criteria, sample sizes, expert ground truth, and MRMC studies cannot be answered from the provided text because these elements are not part of a typical 510(k) for a mechanical spinal implant.

If this were an AI/ML device, the detailed information requested would be crucial. However, for this specific document, that information is not relevant or present.

Ask a specific question about this device

The PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor: pseudoarthrosis; and failed previous fusion.

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

This document describes a spinal fixation system (PSS System) and its regulatory clearance, but it does not contain the type of study that would typically involve acceptance criteria, performance metrics, ground truth, or expert review in the context of AI/device performance.

The provided text pertains to a 510(k) premarket notification for a medical device (a pedicle screw spinal system). This regulatory pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and material specifications, not clinical or diagnostic performance evaluated against expert ground truth.

Therefore, many of the requested elements for the study (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or not present in this type of regulatory submission.

Here's an analysis based on the information available:

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

• Not Applicable in this context. The focus of this 510(k) is mechanical equivalence. The "performance" is primarily mechanical strength and durability.
• The study cited is "Testing in accordance with ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'".
• Acceptance Criteria (Implied): The PSS System must perform "substantially equivalent" to the predicate device (Spinal USA PSS System K071438) when tested according to ASTM F1717. This standard would define specific mechanical tests (e.g., static and dynamic compression, bending, torsion) and their corresponding pass/fail criteria or performance metrics (e.g., maximum load, stiffness, fatigue life).
• Reported Device Performance: The document states: "Testing in accordance with ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model' of the PSS System demonstrates that the device is substantially equivalent to the Spinal USA PSS System (K071438)." Specific numerical performance data from the ASTM F1717 test are not provided in this summary.

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

• Not Applicable (direct interpretation of "test set" for performance evaluation). For mechanical testing, the "sample size" would refer to the number of physical device constructs tested. This information is not provided in the summary but would be detailed in the full test report.
• Data Provenance: The testing was conducted internally by Spinal USA, presumably in a laboratory setting (Country of Origin: USA, as the submitter information is in Mississippi). This is a prospective test in the sense that the new device was built and specifically tested against the standard.

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

• Not Applicable. The "ground truth" for mechanical testing is defined by the physical properties and performance measured under controlled laboratory conditions according to the ASTM standard, not by expert human interpretation.

4. Adjudication method for the test set

• Not Applicable. Mechanical test results are objective measurements (e.g., force, displacement, cycles to failure), not subject to human adjudication for discrepancies.

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

• Not Applicable. This is a mechanical device, not an AI-powered diagnostic or assistive tool.

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

• Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• Mechanical Integrity/Performance according to ASTM F1717 Standard. The "ground truth" is the objective physical behavior of the device under specified loads, measured against the requirements of the standard and compared to the predicate device's performance.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

• Not Applicable.

In summary: The provided document is a regulatory submission for a physical medical device. The "study" mentioned is a mechanical performance study designed to establish substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. It does not involve the types of clinical performance evaluations, expert ground truth, or AI-specific metrics that your questions are geared towards.

Ask a specific question about this device

The PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

The provided text describes a 510(k) premarket notification for a medical device called the "PSS System," a pedicle screw spinal system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria in the manner typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, and MRMC studies) is not applicable to this submission.

Here's a breakdown based on the provided text, highlighting where information is not relevant or available for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI/ML device. The "test set" here refers to the physical samples of the PSS System tested according to ASTM F1717. The number of physical units tested is not specified in this summary.
• Data Provenance: Not applicable in the context of clinical data. This is a mechanical testing study.

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

• Not Applicable. This is a mechanical device, and "ground truth" as it pertains to expert consensus on clinical data is not relevant. The "ground truth" for mechanical testing is defined by the performance standards outlined in ASTM F1717.

4. Adjudication method for the test set

• Not Applicable. Mechanical testing does not involve adjudication by experts in the same way clinical image interpretation or diagnosis does.

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

• No. This is a mechanical spinal fixation system, not an AI/ML device. MRMC studies are not relevant.

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

• No. This is a mechanical device. Standalone algorithm performance is not relevant.

7. The type of ground truth used

• For mechanical devices, the "ground truth" is typically defined by the performance requirements and testing methodologies specified in recognized standards (e.g., ASTM F1717) and successful performance of a legally marketed predicate device. In this case, the PSS system's performance was compared to a previously cleared predicate device (K071438) using ASTM F1717.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable.

Ask a specific question about this device

The PSS System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and ''NON-STERILE".

The provided text describes a medical device, the PSS System, and its substantial equivalence to other legally marketed devices, rather than a study proving performance against acceptance criteria using clinical data and an algorithm. This submission is for a traditional 510(k) premarket notification for a Class II medical device (pedicle screw spinal system), which typically relies on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design and materials, not on clinical performance studies comparing accuracy or efficacy.

Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI/algorithm performance studies which are not characteristic of this type of 510(k) submission.

Here's an attempt to answer based on the provided text, highlighting what is not applicable or not provided:

Acceptance Criteria and Study Details for PSS System

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

Explanation: For a device like the PSS System, acceptance criteria are generally established based on the performance of legally marketed predicate devices. The "study" here is a mechanical testing comparison against these predicates, not a clinical trial with performance metrics like sensitivity/specificity.

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

• Sample size: Not applicable/not provided for mechanical testing comparison. The "test set" would typically refer to physical samples of the device components subjected to testing. The document doesn't specify the number of components tested but implies standard mechanical testing.
• Data provenance: Not applicable. This refers to in-vitro mechanical testing conducted by the manufacturer, not patient data.

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

• Not applicable. This relates to clinical studies and expert consensus for ground truth, which is not relevant for a mechanical testing comparison.

4. Adjudication method for the test set

• Not applicable. This relates to clinical studies and expert review processes, which is not relevant for mechanical testing.

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

• No. This is not a study involving human readers or AI assistance.

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

• No. This is not an algorithm or AI product.

7. The type of ground truth used

• Not applicable. For this type of submission, "ground truth" is established through engineering standards (ASTM F1717) and comparison to the known characteristics and performance of predicate devices. There is no clinical or pathological "ground truth" in the context of this 510(k) clearance.

8. The sample size for the training set

• Not applicable. This term is relevant for machine learning algorithms, which is not applicable here.

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

• Not applicable. This term is relevant for machine learning algorithms, which is not applicable here.

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