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The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

The predicate CapSure® PS System consists of a selection of non-sterile, single use, titanium alloy screws and connectors, and titanium alloy and cobalt chrome rod components that are assembled to create a rigid spinal construct. The components of the predicate CapSure® PS System are attached to the non-cervical spine of skeletally mature patients in order to stabilize the spine during fusion of vertebral bodies, and are intended to be removed after spinal fusion is achieved.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (pedicle screw system), not an AI/software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of submission.

This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through mechanical performance testing for new components.

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this specific 510(k) submission are based on demonstrating that the new components for the CapSure® PS System perform at least as well as the predicate device, specifically in terms of mechanical stability and durability.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a mechanical device like a pedicle screw system, "performance" is primarily measured by its physical properties and mechanical integrity under simulated physiological loads. The standard ASTM F1717 is a recognized standard for testing spinal implant constructs. The "reported performance" is that these tests were conducted and the results demonstrated substantial equivalence.

Study Details (as applicable to a mechanical device 510(k))

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

• Sample Size: Not explicitly stated as "test set" in the context of an algorithm. For mechanical testing, the "sample size" would refer to the number of device components or constructs tested for each configuration. Specific numbers are not provided in this summary, but these tests are typically conducted on multiple samples per configuration to ensure statistical validity (e.g., n=3 or n=6 per test).
• Data Provenance: The testing was conducted internally or by a contract lab on physical components of the CapSure® PS System. This is a prospective experimental study (i.e., new tests were run on the new components) rather than a retrospective analysis of patient data. There is no "country of origin of the data" in the sense of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. "Ground truth" in the context of AI/SaMD (expert consensus, pathology, etc.) is not relevant for the mechanical testing of a pedicle screw system. The "truth" is established by the physical laws and mechanical properties measured in the laboratory according to established ASTM standards. The experts involved would be engineers/scientists designing and conducting the tests and analyzing the mechanical data.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication (e.g., 2+1, 3+1) is a method for resolving discrepancies in expert labeling or diagnoses for ground truth establishment in clinical data. This is not performed for mechanical bench testing.

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

• No. This type of study is specifically for evaluating the impact of AI on human readers' performance (e.g., radiologists interpreting images). It is not relevant for a physical medical device like a pedicle screw system.

6. Standalone (Algorithm Only) Performance

• Not Applicable. There is no algorithm or software being evaluated for standalone performance in this submission.

7. Type of Ground Truth Used

• Engineering/Mechanical Standards and Measurements: The "ground truth" for this device is its physical performance and integrity as measured against established industry standards (ASTM F1717) and compared to the known safe and effective performance of its predicate device. This is determined through controlled laboratory experiments.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical device testing. The device components themselves are the "subject" of the test, and their design is based on engineering principles and prior device knowledge, not machine learning training.

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

• Not Applicable. As there's no training set, there's no ground truth establishment for one. The design and testing methodologies are based on established engineering principles, material science, and regulatory requirements for medical devices.

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The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure® PS System consists of a selection of non-sterile, single use, titanium allov polyaxial screw and connector components, and titanium alloy and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The provided document is a 510(k) premarket notification for a medical device called the "CapSure® PS System," which is a Pedicle Screw Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through a clinical study that would have acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, many of the requested elements for a study proving device performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not applicable to this type of device submission.

Instead, the acceptance criteria and proof of performance for this device are based on mechanical testing to demonstrate that the new components for the CapSure® PS System are substantially equivalent to the previously cleared predicate CapSure® PS System components and other predicate pedicle screw systems.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for a clinical study. For mechanical testing, the "sample size" would refer to the number of components tested according to ASTM F1717. This specific number is not provided in the 510(k) summary, but it would adhere to the sample size requirements of the ASTM F1717 standard itself.
• Data Provenance: The data comes from internal mechanical testing performed by Spine Wave, Inc.

3. 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):

• Not applicable. Ground truth in the context of clinical interpretation by experts is not relevant here as this is a mechanical device, not a diagnostic or AI device. The "ground truth" for mechanical testing is adherence to the specified ASTM standard.

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

• Not applicable. This concept relates to expert review of clinical cases. For mechanical testing, adherence to the ASTM standard is directly measurable.

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 spinal fixation system, not an AI-assisted diagnostic device.

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

• Not applicable. This refers to AI algorithms, which is not relevant to this device.

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

• For mechanical testing, the "ground truth" is adherence to established engineering standards and specifications (ASTM F1717) and demonstrating performance equivalent to the predicate devices.

8. The sample size for the training set:

• Not applicable. This refers to AI training data.

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

• Not applicable. This refers to AI training data.

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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod, screw, and cross connector components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

This 510(k) premarket notification for the CapSure® PS System is for minor modifications to existing screws and relies on substantial equivalence to predicate devices. It does not contain an independent study with acceptance criteria and a device performance table in the typical sense of a new medical device study.

Therefore, many of the requested sections (2-9 relating to sample sizes, expert involvement, ground truth, and comparative effectiveness) are not applicable or cannot be extracted directly from this document.

However, I can describe what was used to demonstrate "performance" in this particular submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In this 510(k), the "acceptance criteria" isn't a specific numerical threshold for a clinical outcome or a diagnostic accuracy metric. Instead, it's the demonstration that the modified device performs equivalently to the already cleared predicate devices. The "reported device performance" is that the chosen analysis method (FEA) confirmed this equivalence.

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

• Not Applicable. This submission did not involve a test set of patient data. The performance evaluation was based on Finite Element Analysis (FEA) of the device modifications.

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

• Not Applicable. No ground truth was established by experts for a test set in this submission. The evaluation was an engineering analysis.

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

• Not Applicable. No test set requiring expert adjudication was used.

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. An MRMC study was not done. This submission is for a pedicle screw system, which is a physical implant, not an AI-assisted diagnostic or interpretative device.

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

• Not Applicable. This is not an algorithm or AI device. The "performance" assessment was an engineering simulation (Finite Element Analysis).

7. The type of ground truth used:

• Not Applicable. No "ground truth" in the clinical or diagnostic sense was established. The performance was assessed through engineering analysis (Finite Element Analysis) demonstrating equivalence to already cleared predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. No training set was used.

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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The provided text describes a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a study evaluating the performance of a device against specific acceptance criteria.

The information typically found in a study demonstrating device performance against acceptance criteria (such as detailed performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment) is not present in this type of regulatory submission. The 510(k) pathway focuses on establishing that a new device is as safe and effective as another legally marketed device (the predicate device) through comparison, often including mechanical testing for physical equivalence.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document states:

• Substantial equivalence: The CapSure® PS System is substantially equivalent to the predicate device, CapSure® PS System (K081228), manufactured by Spine Wave, Inc.
• Proof of equivalence: "mechanical testing demonstrated that the CapSure® PS System is equivalent to its predicate device. The minor differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness."

This indicates that the "study" demonstrating the device meets approval criteria was primarily a mechanical testing study comparing it to the predicate device. However, no specific quantitative acceptance criteria or detailed performance results from this testing are provided in the summary.

Here's why the requested information is absent and what can be inferred:

1. Table of acceptance criteria and reported device performance: Not provided. The 510(k) summary asserts "equivalence" based on mechanical testing without detailing the specific criteria or results.
2. Sample size used for the test set and data provenance: Not applicable in the context of a 510(k) summary focused on mechanical equivalence. "Test set" here refers to mechanical samples, 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. Mechanical testing typically involves engineers and standardized testing protocols, not medical experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set: Not applicable for mechanical testing for 510(k) equivalence.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with AI and is not relevant for a spinal implant's mechanical equivalence.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.
7. Type of ground truth used: For mechanical testing, the "ground truth" would be established by industry standards (e.g., ASTM standards) and the performance of the predicate device under those standards.
8. Sample size for the training set: Not applicable (no algorithmic training involved).
9. How the ground truth for the training set was established: Not applicable.

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