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The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.

The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.

Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:

• Ability to deliver and evacuate endodontic irrigation solutions.
• Performance akin to the predicate device (EndoVac System K140685).
• Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
• Safety and effectiveness equivalent to the predicate.

Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):

The document states that the following performance tests were conducted as part of design verification:

• Suction Flow Rate Performance
• Critical Dimensions for Clinical Performance Analysis
• Corrosion Testing
• Simulated Canal Performance Testing
• Shelf Life Verification
• Biocompatibility Analysis
• Transit Testing
• Additive Manufacturing Summary Document

The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.

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

The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.

Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.

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

This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.

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

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not mentioned.

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. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:

• Reference standards and measurements: For dimensions, flow rates, and physical properties.
• Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
• ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.

8. The sample size for the training set

The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

As there is no "training set" (see point 8), this question is not applicable.

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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, 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 alloy screw and connector components and titanium alloy and cobaltchrome 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 of skeletally mature patients to stabilize the spine during fusion of vertebral bodies and are intended to be removed after spinal fusion is achieved.

This 510(k) premarket notification describes a medical device, the CapSure® PS System, which is a spinal fixation system. The document concerns the addition of new components (4.75 mm diameter cobalt-chrome straight rods and dual-diameter titanium rods) to a previously cleared system.

Therefore, the study described is a performance test to demonstrate that these new components do not degrade the overall device performance and are substantially equivalent to the predicate device. This is not a study involving human or image data with AI systems.

Based on the provided information, I can answer the relevant questions about the device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of samples tested but refers to "worst-case samples of the modified implants."
• Data Provenance: Not applicable as this is a physical device performance test rather than a data-driven study. The testing was 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:
Not applicable. The ground truth (device performance and safety) for this type of mechanical testing is established by adherence to a recognized international standard (ASTM F1717) and engineering analysis, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically associated with human decision-making or image interpretation, not physical device 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:
Not applicable. This is a mechanical device performance study, not a study evaluating human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a mechanical device performance study, not an algorithm performance study.

7. The type of ground truth used:
The ground truth used is conformance to the ASTM F1717 standard for dynamic axial compression bend testing and the determination that the modified implants "do not represent a new worst-case for the system."

8. The sample size for the training set:
Not applicable. There is no training set mentioned or implied as this is a physical device performance test, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

Ask a specific question about this device

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.

This document describes a 510(k) premarket notification for a medical device called the CapSure® PS System, a pedicle screw spinal system. The submission seeks clearance for additional components to an already cleared system. As such, the information provided focuses on the substantial equivalence to a predicate device rather than on novel acceptance criteria and a detailed clinical study demonstrating performance against those criteria as would be required for a de novo submission or a new device with significant technological differences.

Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed study information often associated with AI/software devices, cannot be fully generated. This document pertains to a hardware medical device (pedicle screw system), and therefore, the type of "acceptance criteria" and "study" are different from what one might expect for a software or AI-based device.

However, I can extract the available information related to performance data and the rationale for claiming substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of human subjects or a large dataset often associated with AI/software studies. Instead, it refers to "modified implants" and "constructs previously tested." This implies an engineering test setup with a limited number of physical components for mechanical testing. No specific number is given.
• Data Provenance: Not applicable in the context of clinical data or country of origin. The data provenance is from mechanical testing conducted in accordance with ASTM F1717. The document does not specify where these tests were performed, but given the manufacturer is US-based and seeking FDA clearance, it's presumed to be from a reputable testing facility, likely within the US, or a recognized international body. The tests are "retrospective" in the sense that the modified implants are compared to "constructs previously tested" rather than new testing being exclusively performed for the new components (though some testing was likely done to ensure the comparison is valid).

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

• Not Applicable. This is a hardware medical device; the "ground truth" is established by adherence to recognized mechanical testing standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes in the same way an AI device would. The "experts" involved would be mechanical engineers and test technicians responsible for performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing of hardware, there is no expert adjudication process in the manner of multiple medical professionals independently reviewing cases and reaching a consensus. The "adjudication" is based on whether the devices meet the specified parameters of the ASTM F1717 standard and if the engineering rationale for substantial equivalence is sound.

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

• No. An MRMC study is relevant for evaluating the performance of AI/software in a clinical context (e.g., how AI assistance impacts human readers' diagnostic accuracy). This document pertains to a physical implantable device, so an MRMC study was not conducted or required for this type of submission.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• No. This is a hardware device. There is no standalone algorithm to evaluate.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is the mechanical test results obtained by following recognized industry standards (ASTM F1717) for spinal implant performance, alongside an engineering rationale demonstrating that the updated components do not negatively impact these established performance characteristics and are equivalent to the predicate.

8. Sample Size for the Training Set

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

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

• Not Applicable. There is no training set for this hardware device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 purpose of this submission is to gain clearance for the addition of the LP Cross Connector component to the CapSure® PS System. The LP Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The LP Cross Connector is available in lengths ranging from 38mm to 81mm.

This document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. It does not describe an AI/ML device or present a study comparing AI performance against acceptance criteria. Therefore, most of the requested information cannot be extracted.

However, I can provide what is available regarding the device and its equivalence.

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device to a predicate. Instead, the "acceptance criteria" here refers to demonstrating substantial equivalence to existing legally marketed predicate devices through mechanical testing.

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

This information is not applicable as this is a 510(k) summary for a physical medical device (pedicle screw system), not an AI/ML device requiring a test set of data. The "study" mentioned is mechanical testing. Details about the sample size (number of constructs tested) and data provenance for this mechanical testing are not provided in this summary.

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)

This is not applicable. For mechanical testing of a physical device, ground truth is established by engineering standards and measurements, not by expert consensus on clinical data.

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

This is not applicable as there is no test set in the context of clinical data requiring expert adjudication.

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. This document pertains to a physical spinal implant device, not an AI system that assists human readers.

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

This is not applicable as this is not an AI algorithm.

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

For the mechanical testing, the "ground truth" would be the established engineering standards, material properties, and biomechanical parameters against which the device's performance was measured. No clinical ground truth from patient data (expert consensus, pathology, or outcomes) is mentioned in the context of this 510(k) summary for the equivalence determination.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML system.

Ask a specific question about this device

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.

This purpose of this submission is to gain clearance for the addition of an optional Cross Connector component to the CapSure® PS System. The Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The Cross Connector is available in lengths ranging from 35mm to 100mm.

The provided documentation does not contain information regarding the acceptance criteria, device performance tables, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system, and its optional Cross Connector component. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than reporting on the performance of an AI/ML-based device against specific acceptance criteria.

Therefore, I cannot fulfill your request with the information provided.

Ask a specific question about this device

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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