(132 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 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
| Acceptance Criteria (What the device must demonstrate) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Static Axial Compression Performance | Demonstrated performance in accordance with ASTM 2077-03. |
| Dynamic Axial Compression Performance | Demonstrated performance in accordance with ASTM 2077-03. |
| Static Shear Compression Performance | Demonstrated performance in accordance with ASTM 2077-03. |
| Dynamic Shear Compression Performance | Demonstrated performance in accordance with ASTM 2077-03. |
| Subsidence Resistance | Not explicitly tested for the new sizes, as predicate devices were determined to be more worst-case. This implies the new sizes are expected to meet or exceed predicate performance due to design similarities/improvements. |
| Substantial Equivalence to Predicate Devices | Mechanical test results were provided, demonstrating substantial equivalence to: K083026 (CLYDESDALETM) and K073291 (CAPSTONE®). |
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.
§ 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.