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The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-IF system is an implant system for interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add a notch in the posterior portion of the U-shaped body. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

Here's a breakdown of the acceptance criteria and study information for the coflex-IF device, based on the provided FDA 510(k) summary:

• Note: This document is a 510(k) summary for a spinal implant (coflex-IF), which is a physical medical device, not a software or AI-based diagnostic device. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) are not applicable to this type of submission. The information provided focuses on engineering and mechanical testing for substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Information (Where applicable, based on a physical medical device)

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

   • Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data, but "The worst case device" was tested. This refers to a manufactured physical device chosen as representative of the most challenging conditions or configurations.
   • Data Provenance: Not applicable in the context of human data. The testing is described as mechanical performance testing of the device itself.

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

   • Not applicable. Ground truth for a physical device's mechanical performance is established through standardized engineering tests (e.g., ASTM F 1717-13) and comparison to the predicate device, not expert consensus on human data.

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

   • Not applicable. Mechanical testing results are objective measurements of physical properties, not subject to human adjudication in the way clinical diagnostic interpretations would be.

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:

   • Not applicable. This is a physical spinal implant, not an AI software/diagnostic device.

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

   • Not applicable. This is a physical spinal implant, not an AI algorithm.

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

   • For mechanical performance, the "ground truth" is defined by the standards set by ASTM F 1717-13 and the established performance of the predicate device. The goal is substantial equivalence, meaning the new device performs acceptably within the same safety and effectiveness parameters as the legally marketed predicate.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model requiring a training set of data. Device design and manufacturing parameters are based on engineering principles and material science, not machine learning.

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

   • Not applicable. As above, there is no AI training set for this type of device.

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The DSS™ Stabilization System - Rigid is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft.

Note: The Rigid Couplers are for single-level use only. The traditional straight rods are for single- and multi-level use.

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:

• Who are receiving fusions with autogenous graft only;
• Who are having the device fixed or attached to the lumbar or sacral spine;
• Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSSTM Stabilization System is comprised of a variety of pedicle screw sizes, couplers, and straight rods that act as longitudinal components that are uniquely fitted for each individual case. The pedicle screws, couplers, and straight rods are manufactured from medical grade titanium alloy (Ti6Al4V).

The purpose of this 510(k) is to add multi-level use for the traditional straight rod components of the DSSTM Stabilization System - Rigid.

The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid. This document describes a medical device and its substantial equivalence to previously cleared devices. It does not contain information about a study involving human readers or AI assistance. The "study" described is a performance test to demonstrate mechanical equivalence, not clinical performance.

Here's an analysis based on the information provided and what is typically found in a 510(k) for devices like this:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
For this type of device (spinal fixation system), the primary "acceptance criteria" and "device performance" in a 510(k) submission are typically based on mechanical testing per recognized standards (like ASTM F1717) to prove that the new device is functionally equivalent to existing cleared predicate devices. The document explicitly states that "Previous performance testing per ASTM F1717... and comparison to the predicates the DSS™ Stabilization System - Rigid is substantially equivalent to predicate devices." This means the performance of the new device met or exceeded the performance of the predicate devices in these mechanical tests, thus demonstrating substantial equivalence. The predicate devices themselves would have already established their safety and effectiveness through similar mechanical testing and potentially clinical use.

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

• Sample Size: The document does not specify the exact sample size for the mechanical tests. ASTM F1717 generally specifies the number of samples required for each test. For medical device mechanical testing, these are typically small numbers of physical device units (e.g., n=5, n=6, n=10 per test condition) rather than human subjects or data sets.
• Data Provenance: Not applicable in the context of this 510(k). The "data" comes from physical mechanical testing of the device components, not from patient data, and is prospective in the sense that the tests were performed specifically for this submission.

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

• This question is not applicable as the "test set" here refers to mechanical performance testing of a physical device, not an AI algorithm evaluated by human experts. The "ground truth" is based on the physical properties and mechanical behavior of the device components under various loads, as measured by standard laboratory equipment and procedures, not expert consensus.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as (3). Mechanical test results are typically objective measurements, not subject to individual 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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (spinal stabilization system), not an AI algorithm. Therefore, there is no discussion of human readers, AI assistance, or effect size related to AI improvement.

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

• No, a standalone algorithm performance study was not done. This document is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the device's performance is established by objective measurements from standardized mechanical tests (per ASTM F1717). This involves measuring properties like displacement, load at failure, and fatigue cycles. The "truth" is the physical behavior of the material and design under controlled conditions, not a clinical outcome or expert interpretation.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment for a physical device.

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The coflex-F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-F Implant System is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, Ushaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add small- and medium-sized coflex-F Short devices to the coflex-F Implant System. The modifications are intended to allow the operating surgeon to better accommodate various patient anatomies. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the changes introduced by the modified coflex-F Short implant system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes an engineering and biocompatibility study for a medical device modification, not a clinical trial with a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data are not applicable to this submission.

The "test set" here refers to the new small- and medium-sized coflex-F Short devices themselves, which were subjected to:

• Finite Element Analysis: This is a computational simulation, not a test on a physical sample size in the traditional sense. The "sample" is the digital model of the device.
• Biocompatibility Tests: These tests would have used samples of the materials of the device-specific instruments. The exact number of material samples isn't specified, but it would be according to ISO 10993 standards.

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

This section is not applicable as the described study is a non-clinical evaluation of device modification (mechanical and biocompatibility), not a study involving human interpretation of clinical data where expert ground truth would be established. The "ground truth" for the engineering analysis would be the established principles of mechanics, and for biocompatibility, it would be the ISO 10993 standards themselves.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. There was no human interpretation of data requiring 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. The device described is a spinal implant, and the study focuses on its mechanical integrity and biocompatibility, not on an AI-based diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The ground truth for the finite element analysis is the established principles of mechanical engineering and physics as applied to the finite element models, and comparison of the results against the predicate device's established performance parameters.
• Biocompatibility: The ground truth for biocompatibility is conformance to ISO 10993 standards for irritation and sensitization.
• Substantial Equivalence: The ground truth for substantial equivalence is the predicate device's (K093438) cleared specifications regarding indications, design, function, and materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device modification study. The study involves engineering analysis and biocompatibility testing of physical materials, not machine learning algorithms.

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

This is not applicable for the same reasons as #8.

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DSSTM Stabilization System - Rigid

The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; .
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• . Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).

The purpose of this Special 510(k) is to add a straight rod, straight rod with pan, and polyaxial screw to the DSS Stabilization System - Rigid. The modifications are intended to allow the operating surgeon to better accommodate patient anatomies with more construct options. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The performance testing relies on mechanical testing per ASTM F1717. Therefore, the concept of sample size and data provenance from patient data is not applicable here. The "sample size" would refer to the number of devices tested under each mechanical test condition, which is not provided.

3. Number of Experts and Qualifications for Ground Truth

Again, this section is not applicable to the type of study presented. Ground truth in this context is established by standardized mechanical testing protocols (ASTM F1717) and comparison to the performance of previously cleared predicate devices, not by expert consensus on clinical findings.

4. Adjudication Method for Test Set

Not applicable. There is no clinical test set requiring adjudication in this submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical substantial equivalence to predicate devices, not on the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical implant, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used is based on established engineering standards and performance data of previously cleared predicate devices. Specifically, the "ground truth" for substantial equivalence is the demonstration that the DSS™ Stabilization System - Rigid performs equivalently to predicate devices under the mechanical stress tests outlined in ASTM F1717.

8. Sample Size for Training Set

Not applicable. This submission does not involve an AI algorithm or a "training set" in the context of machine learning. The "training" for this device's acceptance is based on its mechanical properties meeting established standards compared to existing devices.

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's acceptance relates to its physical performance characteristics as determined by standardized testing methods.

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The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The Paradigm Interspinous Fusion Plate is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6A14V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

This 510(k) submission (K093438) describes the Paradigm Interspinous Fusion Plate, a spinal implant, and focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics for acceptance criteria and a detailed study report for meeting those. Instead, it relies on preclinical and clinical data comparisons.

Here's an breakdown based on the provided text, addressing your questions where possible and noting limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantified acceptance criteria in the format you've requested (e.g., "Accuracy > X%", "Sensitivity > Y%"). Instead, it states that "Performance testing demonstrated Paradigm Interspinous Fusion Plate is substantially equivalent to predicate devices."

The performance is described as:

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

• Test Set Sample Size: Not specified. The submission mentions "clinical data was provided" but does not give the number of patients or cases in any comparative clinical study.
• Data Provenance: Not specified. It's unclear if the clinical data was retrospective or prospective, or the country of origin. Given the typical nature of 510(k) submissions, especially for an implant like this, the "clinical data" likely refers to evidence gathered on the predicate devices or general clinical performance related to the indication, rather than a dedicated new clinical trial for this specific device.

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

This information is not provided in the submission. For a device like an interspinous fusion plate, "ground truth" for the test set would typically relate to clinical outcomes (fusion rates, pain reduction, adverse events) as evaluated by clinicians (surgeons, radiologists) over time. However, the details of how this was established for this specific device's clinical data are not present.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study was not done, as this device is a physical implant (spine plate), not an AI/imaging diagnostic tool that would typically involve human readers interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical implant and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

For the preclinical testing, the ground truth was based on engineering standards and measurements of mechanical properties (tension, compression, torsion, etc.).

For the clinical data, the "ground truth" implicitly relates to clinical outcomes (e.g., successful fusion, symptom resolution, absence of device failure or adverse events), typically assessed by surgeons, radiologists, and patient reports. However, the specific methodology for establishing this ground truth is not detailed for this particular device's submission.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical implant and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as above.

Summary of the Study that Proves Substantial Equivalence:

The submission leverages preclinical (bench) testing and clinical data comparison to demonstrate substantial equivalence.

• Preclinical Testing: This involved a series of mechanical tests—static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening, and tightening. The "study" here involved performing these tests on the Paradigm Interspinous Fusion Plate and comparing the results to those obtained for the predicate devices (Medtronic SPIRE (K032037), Lanx Spinous Process Plate (K071877), and NuVasive Spinous Process Plate System (K073278)). The implicit "acceptance criteria" for these tests were that the Paradigm plate's performance should be comparable to or better than the predicates, thus establishing substantial equivalence in mechanical properties.

• Clinical Data: The submission states that "clinical data was provided to demonstrate substantially equivalent performance of the subject device to predicate devices." This likely involved referencing existing clinical data or literature on the predicate devices and demonstrating that the Paradigm plate, with its similar design, function, and materials, would be expected to achieve similar clinical outcomes (e.g., fusion rates, complication profiles) as observed with the predicates. It is highly improbable that a new, dedicated clinical trial was conducted solely for this 510(k) submission for this type of device. The exact nature and scope of this clinical data are not detailed.

In essence, the "study" for this 510(k) approval was a comparison against established, cleared devices (predicates) across both mechanical performance and expected clinical outcomes, rather than a de novo investigation with its own distinct acceptance criteria and study endpoints.

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The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor: pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:
Who are receiving fusions with autogenous graft only;
Who are having the device fixed or attached to the lumbar or sacral spine;
Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System -- Rigid is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). This submission presents the addition of a 20mm long rigid coupler.

The provided text describes a medical device, the DSS™ Stabilization System -- Rigid, and its 510(k) premarket notification (K101083). The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical mechanical testing.

Here's an analysis of the provided information against the requested categories:

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

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

The document describes non-clinical mechanical testing, not a clinical study involving human patients or data provenance in that sense. The "sample size" refers to the number of test articles used in the mechanical tests. The document states: "Static and dynamic mechanical testing was performed in conjunction with ASTM F1717." While it confirms that testing was done, the exact number of samples (test articles) used for each specific test (static flexion, extension, axial rotation, dynamic compression bending) is not explicitly stated.

The data provenance is from non-clinical laboratory testing of the device components, not from human subjects or clinical data.

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 question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties and behavior of the materials and device constructs, not by expert human interpretation.

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

This question is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions on clinical outcomes or image interpretations. For mechanical testing, the results are derived from physical measurements and engineering analyses, not subjective interpretation requiring "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 question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. This submission is for a spinal implant, which undergoes mechanical testing and not typically MRMC studies for its premarket clearance.

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

This question is not applicable. This device is a physical spinal implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for this submission's non-clinical testing is based on established engineering standards and material science principles, specifically ASTM F1717. The performance of the device is measured against the expected mechanical properties and behavior defined by this standard and compared to the performance of predicate devices.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a mechanical device is its design and manufacturing process according to engineering principles.

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

This question is not applicable, as there is no "training set" in the context of this traditional medical device submission.

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DSSTM Stabilization System - Rigid: The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrac in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted: The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; . Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6AI4V).

The provided text describes a 510(k) submission for the DSS™ Stabilization System, a medical device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in clinical validation studies for AI/software devices.

This document describes a spinal pedicle screw system, which is a physical implant, not an AI or software-based device. The approval process for such devices relies heavily on demonstrating substantial equivalence to predicate devices through design, function, material comparison, and mechanical testing, rather than clinical efficacy studies with ground truth derived from expert consensus or pathology, as would be the case for AI systems.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary for the DSS™ Stabilization System.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

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

Explanation: For a physical device like a pedicle screw system, "acceptance criteria" primarily revolve around demonstrating substantial equivalence to already-approved predicate devices in terms of safety and effectiveness. This is typically achieved through comparisons of design, materials, function, and mechanical testing results against established benchmarks or the predicate devices themselves. The document states that the device was shown to be "substantially equivalent" and "as mechanically sound" as predicates.

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

• Not applicable / Not provided. The document describes mechanical testing, not a clinical study involving human patients or data sets. "Sample size" in this context would refer to the number of devices or components subjected to mechanical tests, which is not specified. There is no "data provenance" in the sense of patient data.

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 / Not provided. This device's approval involved mechanical engineering assessments and regulatory review, not expert consensus on clinical data to establish a ground truth.

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

• Not applicable / Not provided. Adjudication methods are relevant for clinical studies where human experts interpret data, which is not described here.

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 physical medical device, not an AI system. Therefore, no MRMC study or assessment of AI assistance was performed.

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.

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

• Not applicable for clinical ground truth. The "truth" for this device's approval revolved around engineering specifications, materials science, and mechanical performance validation, demonstrated to be equivalent to existing, legally marketed devices.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/machine learning system.

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

• Not applicable. No training set was used.

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The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients:

Who are receiving fusions with autogenous graft only;

Who are having the device fixed or attached to the lumbar or sacral spine: ●
Who are having the device removed after the development of a solid . fusion mass."

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The subject systems are comprised of a variety of pedicle screws and Couplers that act as longitudinal spacers. The systems are intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.

The subject systems are fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136).

Here's an analysis of the provided text regarding the DSS™ Stabilization System and its submission for 510(k) clearance:

Important Note: The provided text is a 510(k) Summary for a medical device. 510(k) clearances for devices like this (pedicle screw spinal systems) typically do NOT involve AI, machine learning, or software-based diagnostics. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and material performance testing. Therefore, many of the questions related to AI/ML and human-in-the-loop performance will not be applicable.

Acceptance Criteria and Device Performance (Based on provided text)

Explanation of "Acceptance Criteria" for this device: For a 510(k) pathway for a pedicle screw spinal system, "acceptance criteria" are not typically framed as specific statistical thresholds for diagnostic performance (like sensitivity/specificity for an AI device). Instead, they revolve around demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as a legally marketed device that performs the same function. The primary evidence for this in the provided document is through:

• Material composition: Matching established standards and predicate devices.
• Design, Function, Intended Use, Indications for Use: Being demonstrably similar to predicate devices.
• Performance Testing: While the details are not given, this would involve mechanical testing (e.g., static and dynamic compression, bending, torsion) to ensure the device meets or exceeds the mechanical properties and safety profiles of the predicate, as per relevant ASTM or ISO standards for spinal implants. The "Performance Standards" section vaguely states that testing confirms substantial equivalence.

Study Details (Based on provided text)

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

   • Test Set Sample Size: Not applicable in the context of an AI/ML test set. For a mechanical device, testing would involve a sufficient number of devices/components to establish statistical significance for mechanical properties, but the specific number is not provided in this summary.
   • Data Provenance: Not applicable for AI/ML. The "data" here would be the results of mechanical and material tests, likely conducted in a controlled laboratory environment.

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

   • Not applicable. "Ground truth" in this context refers to regulatory compliance and mechanical performance, not a diagnostic assessment by experts. Design and manufacturing were likely overseen by engineers and quality control personnel.

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

   • Not applicable.

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:

   • Not applicable. This is a mechanical implant, not an AI diagnostic tool.

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

   • Not applicable. This is a mechanical implant.

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

   • For this device, the "ground truth" for substantial equivalence is primarily based on:
     • Compliance with recognized standards: Material standards (ISO 5832-3, ASTM F136).
     • Reproducibility of mechanical properties: Laboratory-tested mechanical performance comparing the new device to the predicate device and relevant industry standards for spinal implant strength and durability.
     • Pre-clinical data: Likely involved bench testing and potentially biomechanical cadaver studies (though not explicitly detailed in the summary).

7. The sample size for the training set:

   • Not applicable. There is no AI/ML training set.

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

   • Not applicable. There is no AI/ML training set.

Summary for K090099:

This 510(k) summary is for a pedicle screw spinal system, a mechanical implant. The entire submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices. This means proving that the new device has the same intended use, indications for use, technological characteristics (materials, design, function), and performs as safely and effectively as the predicate. The "study" here refers to the engineering and performance testing that verifies the device's mechanical integrity and material compliance, not a clinical trial or an AI/ML validation study.

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The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autograft and/or allograft.

This 510(k) adds additional screw sizes to the DSS™ Stabilization System. The DSSTM Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).

Here's an analysis of the provided text regarding the Paradigm Spine DSS™ Stabilization System and its 510(k) submission (K090408), focusing on the acceptance criteria and the study (or lack thereof) proving the device meets them:

No clinical performance study or specific acceptance criteria are described in the provided 510(k) summary documents.

The provided documents are a 510(k) summary and the FDA's clearance letter. For a Class III device like a pedicle screw spinal system, the FDA typically determines substantial equivalence based on a comparison to a legally marketed predicate device. This often involves demonstrating equivalent technological characteristics and performance through non-clinical (e.g., mechanical) testing, rather than extensive clinical efficacy trials, especially for devices introducing minor modifications (like additional screw sizes as stated here).

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be filled from the given text.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, specific acceptance criteria for clinical performance and reported device performance are NOT detailed.

The approval is based on "substantial equivalence" to a predicate device (K080241). The performance stated is that:

Note: "Mechanical Soundness" implies that the device met certain mechanical testing standards (e.g., fatigue, static strength), but the specific criteria (e.g., force levels, cycles) are not provided in this summary.

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

• Sample Size for Test Set: Not applicable/not provided for clinical performance. The "test set" would refer to mechanical testing samples, which are not detailed here.
• Data Provenance: Not applicable/not provided for clinical performance. The mechanical testing data would likely be from the manufacturer's internal labs.

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

• Not applicable, as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication is described.

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

• No, an MRMC comparative effectiveness study was not done or described in these documents. This is a mechanical orthopedic device, not an imaging AI diagnostic device, so MRMC studies are generally not relevant for 510(k) clearance of this type of product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable for clinical performance. For mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device and established standards for pedicle screw spinal systems.

8. The Sample Size for the Training Set

• Not applicable. This is a medical implant device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a medical implant device, not an AI/ML algorithm.

Summary of 510(k) Clearance for K090408:

The K090408 submission was a Special 510(k), specifically to add additional screw sizes to an already cleared DSS™ Stabilization System (predicate K080241). The primary basis for clearance was a demonstration of substantial equivalence to the predicate device in terms of:

• Mechanical Soundness: Testing indicated the new screw sizes were "as mechanically sound as predicate devices."
• Indications for Use: The system maintained the same indications as the predicate.
• Design, Function, and Materials: These were also consistent with the predicate.

The FDA's review concluded that there was a reasonable likelihood that the device could be used for spinal stabilization without fusion, which could cause harm. Therefore, a specific Warning was mandated in the labeling: "The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with autogenous bone graft is being performed at all instrumented levels." This indicates a careful consideration of the intended use and potential off-label use, even in the absence of a de novo clinical trial for this specific 510(k).

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The DSSTM Stabilization System - Rigid Coupler is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autografl and/or allograft.

The DSS™ Stabilization System – Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back opin of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal sterensis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System is comprised of a variety of pedicle screws and Rigid Couplers that act as longitudinal spacers. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.

The DSS™ Stabilization System consists of:

• DSS™ pedicle screw sets .
• DSS™ Rigid Couplers .

The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V (ISO 5832-3 and ASTM F136).

The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid Coupler, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance metrics through a standalone clinical study.

Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth, as these are typically part of a de novo classification or a Premarket Approval (PMA) application requiring clinical trial data.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not available: The document asserts substantial equivalence to predicate devices based on "the same indications for use, design, function, and materials used." It does not define specific performance acceptance criteria or report quantitative device performance data against such criteria. The "Performance Standards" section only states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices."

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

• Not available: No test set or clinical study data is mentioned in this 510(k) summary. The equivalence is based on design, materials, and established predicate devices, not on a new clinical performance study.

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/Not available: As no test set from a clinical study is described, there's no mention of experts or ground truth establishment.

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

• Not applicable/Not available: No test set or clinical study is described.

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/Not available: This device is a pedicle screw spinal system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant.

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

• Not applicable/Not available: This device is a physical implant, not an algorithm.

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

• Not applicable/Not available: No clinical study or ground truth establishment is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable/Not available: No training set for an algorithm is relevant to this device submission.

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

• Not applicable/Not available: No training set is relevant.

Summary of the Study (as described in the 510(k) summary):

The "study" presented in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, Paradigm Spine, LLC, sought to demonstrate that their DSS™ Stabilization System - Rigid Coupler is as safe and effective as existing devices.

• Methodology: The comparison focused on general characteristics like indications for use, design, function, and materials used.
• Predicate Devices: Four predicate devices were identified:
  • DePuy MOSS Miami (K962628)
  • Biomet Synergy VLS Open (K973836)
  • Synthes Pangea (K052123)
  • Zimmer Silhouctte (K993067)
• Materials: The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V, which is a standard material (ISO 5832-3 and ASTM F136).
• Performance Standards (Testing): The document states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices." While this implies some form of engineering or mechanical testing was conducted, the specifics (e.g., specific test methods, number of samples, pass/fail criteria, or detailed results) are not provided in this summary. The "tests" would likely relate to mechanical properties, fatigue, and other biomechanical assessments required for spinal implants to ensure they meet established standards and are comparable to predicate devices.

In essence, the "acceptance criteria" here is the FDA's determination of substantial equivalence, which is based on a comparison to predicate devices rather than independent, quantitative performance metrics from a new clinical study.

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