(20 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™ OPTIMA™ LT-1 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 allows them to be packed with autogenous bone graft.
Here is an analysis of the provided text regarding the CLYDESDALE® Spinal System:
The provided document is a 510(k) summary for the CLYDESDALE® Spinal System, specifically for a Special 510(k) submission seeking clearance for "additional size options" to an already cleared device. This type of submission typically relies heavily on equivalence to a predicate device and engineering rationales, rather than new, extensive clinical trials. Therefore, much of the information requested in your prompt (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance) is not applicable or not provided in this type of regulatory submission for a physical medical device like a spinal implant. These kinds of details are more common for AI/ML-based diagnostic or imaging devices.
Based on the provided text, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Summary of Rationale) |
|---|---|
| Mechanical Performance: |
- Resist loads during interbody fusion.
- Maintain stability and support vertebral bodies.
- Demonstrate acceptable subsidence characteristics. | Substantially Equivalent to Predicate Devices:
- Engineering Theoretical Analysis based on predicate testing in accordance with ASTM F2077-03 ("Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-04 ("Standard Test Method for Measuring Load Induced Subsidence for the Intervertebral Body Fusion Device under Static Axial Compression").
- Data provided demonstrated substantial equivalence to predicate devices (CLYDESDALE® Spinal System K100175, PERIMETER™ Spinal System K090353, CAPSTONE® Spinal System K073291). |
| Material Biocompatibility: - PEEK™ OPTIMA™ LT-1 material is safe and compatible for implantation. | Same Material as Predicate:
- The fundamental technology and material (PEEK™ OPTIMA™ LT-1) are the same as the current CLYDESDALE® Spinal System (K100175). Biocompatibility would have been established for the original clearance. |
| Design Integrity: - New sizes do not compromise the device's fundamental design or function. | Minor Dimensional Changes:
- The design is fundamentally the same as the current CLYDESDALE® Spinal System, with only minor dimensional changes for additional size options. |
| Indications for Use: - Suitable for DDD patients at L2-S1 with specified conditions (spondylolisthesis, non-operative treatment, skeletally mature). | Same Indications for Use as Predicate:
- The indications for use are identical to the predicate device, further supporting equivalence. |
Study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is a non-clinical testing program involving "Engineering Theoretical Analysis" based on predicate device testing. This involved testing performed in accordance with established ASTM (American Society for Testing and Materials) standards:
- ASTM F2077-03: "Test Methods for Intervertebral Body Fusion Devices"
- ASTM F2267-04: "Standard Test Method for Measuring Load Induced Subsidence for the Intervertebral Body Fusion Device under Static Axial Compression"
The "data to support these rationales were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices." This means that the new sizes were shown to perform mechanically comparably to already cleared devices under standardized test conditions, and the material and fundamental design remained unchanged.
Additional Information Breakdown:
2. 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 applicable in the context of this 510(k) for a physical implant. The documentation refers to engineering testing based on ASTM standards, not a patient-based test set. The "samples" would be a certain number of manufactured devices tested according to the ASTM protocols. The specific number of devices tested is not detailed in this summary.
- Data Provenance: Not applicable for patient data. The engineering tests would have been performed in a lab setting, likely in the US (given the company's US address and FDA submission).
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 this context would refer to the established mechanical properties and performance standards defined by the ASTM committees that developed the test methods, as well as the mechanical testing engineers who conducted the tests and interpreted the results. There were no human experts establishing ground truth for a diagnostic outcome in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring human 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
- Not applicable. This is not an AI/ML-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards and established mechanical properties as defined by ASTM test methodologies. The "truth" is whether the device can withstand specified loads, exhibits acceptable subsidence, and matches the performance established for its predicate devices through these objective engineering tests.
8. The sample size for the training set
- Not applicable. This is not an AI/ML-based system. Any "training" would refer to the iterative design and testing processes that led to the predicate device and the subsequent verification of the new sizes.
9. How the ground truth for the training set was established
- Not applicable. See #8.
§ 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.