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The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft. The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).

The information provided pertains to the CLYDESDALE® Spinal System, which is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets those criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The report states, "Based on the results, the subject implants demonstrated that they are as safe, as effective and perform as well as the predicate device(s)." This indicates that the acceptance criteria were met by showing equivalency to predicate devices in mechanical testing.

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

This submission did not involve clinical testing. The tests conducted were non-clinical mechanical tests on the device itself. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature. The tests were performed on the medical devices (implants).

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

Not applicable. As this was a non-clinical mechanical study, no human experts were involved in establishing a "ground truth" for a test set of patient data. The ground truth was established by the specified mechanical testing standards.

4. Adjudication Method for the Test Set

Not applicable. No human readers or adjudication method were involved as this was a non-clinical mechanical study.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this was a non-clinical mechanical study. No human readers or AI were involved in the evaluation of the device's performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

The ground truth for this study was based on established mechanical testing standards and the performance of legally marketed predicate devices. Specifically, the device's performance was compared to the requirements outlined in the FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device," and demonstrated substantial equivalence to predicate devices.

8. Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a physical device, no ground truth needed to be established for it.

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The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft.

The provided text is a 510(k) summary for the CLYDESDALE® Spinal System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria and device performance in the way a clinical trial or AI device study would.

The submission states that the current device is a modified labeling version of a previously cleared device (CLYDESDALE® Spinal System K113528). The core device design, materials, indications, and sterilization remain unchanged. Therefore, the "study" described is a validation of this labeling modification.

Here's an analysis based on the provided text, structured to answer your questions where applicable:

Acceptance Criteria and Device Performance

Since this submission is for a labeling modification and asserts substantial equivalence, explicit "acceptance criteria" for device performance in a clinical or AI sense are not detailed. Instead, the acceptance criterion implicitly is that the revised labeling does not negatively impact the safety and effectiveness of the device and remains congruent with the device's original validated performance characteristics.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

Study Details

Given the nature of this 510(k) for a labeling change, the "study" is a cadaveric surgeon validation of the new labeling.

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

   • Sample Size: Not specified in the document.
   • Data Provenance: The study involved "cadaveric surgeon validation." This implies the data was generated from procedures performed on cadavers, likely in a controlled laboratory setting. The country of origin is not specified but given the submitter (Medtronic Sofamor Danek USA, Inc., Memphis, Tennessee), it likely occurred in the USA. It would be considered a prospective validation of the labeling in a simulated surgical environment.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: The validation was performed by a "cadaveric surgeon." This indicates the expert(s) were qualified surgeons with experience in cadaveric procedures relevant to spinal surgery. Specific years of experience or sub-specialty are not detailed.

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

   • Adjudication Method: Not specified. Given the description, it's likely qualitative feedback from the surgeon(s) performing the validation, rather than a formal adjudicated assessment required for outcome-based studies.

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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a physical medical implant, not an AI/imaging diagnostic tool.

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

   • Standalone Study: No, this is not an AI algorithm. A "standalone" performance assessment for this type of device would typically involve bench testing for mechanical properties, which is generally done for the initial device clearance, but not explicitly stated as having been re-done for this labeling change. The cadaveric validation involved human surgeons.

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

   • Ground Truth: For the cadaveric surgeon validation of labeling, the "ground truth" would be the expert opinion/assessment of the surgeon(s) regarding the clarity, accuracy, and usability of the revised labeling in the context of performing the procedure. This is not "pathology" or "outcomes data" in a clinical sense.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI/machine learning study.

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

   • Ground Truth for Training Set: Not applicable. This is not an AI/machine learning study.

Summary of the Study (Cadaveric Surgeon Validation):

The "study" conducted for this 510(k) submission was a cadaveric surgeon validation. Its purpose was to confirm that a modification to the device's labeling did not alter its intended use or fundamental scientific technology, and that the new labeling was appropriate for the device. The data from this validation supported the claim that the device (with its new labeling) remained substantially equivalent to its predicate device. This type of validation is common for minor changes in medical devices, particularly when the core technology and indications for use have already been established and cleared.

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The CLYDESDALE™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE™ Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE™ Spinal System consists of a variety of hollow vertebral body spacers featuring a convex. bullet nose design and an axial void designed to hold autogenous graft material. The subject device is comprised of medical grade PEEK Optima 1 and includes Tantalum markers for imaging purposes. This device is designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The predicate device ranges from 8mm to 16mm in height and from 45mm to 60mm in length. The purpose ofithis submission was to expand the sizes of the device to include a 40mm length device.

Here's an analysis of the provided text regarding the CLYDESDALETM Spinal System's acceptance criteria and the study proving it meets these criteria:

Device Acceptance Criteria and Performance Study: CLYDESDALETM Spinal System

Based on the provided K100175 document, the CLYDESDALETM Spinal System is a medical device for intervertebral body fusion. The acceptance criteria and the study proving substantial equivalence are focused on mechanical performance and demonstrating that the expanded sizes of the device (specifically, the 40mm length) maintain the same safety and effectiveness as the predicate devices.

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 the exact number of test samples (e.g., how many 40mm length devices were tested) for each mechanical test. It simply states that "mechanical tests... were performed."
• Data Provenance: The data is generated from non-clinical mechanical tests conducted on the device itself. The document does not indicate any human or animal data, nor any specific country of origin for the testing or data. It is inherently prospective, as it's testing the specific device submitted for clearance.

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

This section is not applicable for this type of device and study. The "ground truth" for mechanical component testing is established through standardized engineering test methods (ASTM 2077-03 in this case) and physical measurements, not through expert consensus or interpretation of medical images/outcomes.

4. Adjudication Method for the Test Set

This section is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical image reading) where disagreement among experts needs resolution.

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 section is not applicable. The CLYDESDALETM Spinal System is a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison would be performed.

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

This section is not applicable. As a physical implant, there is no "algorithm only" or "human-in-the-loop" performance to evaluate. The device's performance is solely based on its mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is objective mechanical performance metrics defined by internationally recognized engineering standards (specifically, ASTM 2077-03). The device's ability to withstand specified loads (static axial compression, dynamic axial compression, static shear compression, dynamic shear compression) to acceptable limits constitutes the "ground truth" for its safety and effectiveness in a mechanical context. Comparison to predicate device performance also serves as a ground truth for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. Mechanical testing for medical devices like this does not involve "training sets" in the machine learning sense. The tests are designed to evaluate the physical properties of the manufactured device.

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

This section is not applicable for the same reasons as point 8.

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The CLYDESDALE™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE™ Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

Not Found

I am sorry, but the provided text from the FDA 510(k) K083026 for the "CLYDESDALE™ Spinal System" does not contain information about acceptance criteria or a study proving the device meets those criteria.

This document is a letter from the FDA to Medtronic Sofamor Danek, stating that their device, the CLYDESDALE™ Spinal System, has been deemed "substantially equivalent" to legally marketed predicate devices. This is a common outcome for 510(k) submissions, where the focus is on demonstrating equivalence to existing devices rather than meeting new, specific performance criteria through extensive clinical studies specifically designed for acceptance.

Therefore, I cannot provide the requested information, as it is not present in the given text. The document primarily covers regulatory approval, indications for use, and general control provisions.

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