(25 days)
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):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Labeling modification is validated. | Data from a cadaveric surgeon validation supports the labeling modification. |
| Intended use has not changed. | The intended use has not changed as a result of this labeling modification. |
| Substantial equivalence to predicate device maintained. | The device is substantially equivalent to the predicate device K113528. |
Study Details
Given the nature of this 510(k) for a labeling change, the "study" is a cadaveric surgeon validation of the new labeling.
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning study.
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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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.