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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. 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.

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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, 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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