(91 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-nosed interbody device designed with an axial void to contain autogenous graft material, and facilitate a fusion between two vertebral bodies. This device is designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The device is manufactured from medical grade polyetheretherketone (PEEK) Optima 1 and includes Tantalum markers for imaging purposes and provided sterile by gamma irradiation. The predicate device is available in a variety of sizes ranging from 8mm to 16mm in height and 40mm to 60mm in length. The purpose of this submission is to add a new Direct Lateral (DL) Inserter instrument to be used with the CL YDESDALE® Spinal System.
The provided text is a 510(k) summary for a medical device called the CLYDESDALE® Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria through a study with performance metrics for a novel technology or an AI model.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it does not contain such a study design.
The core of this 510(k) submission is to add a new instrument (Direct Lateral (DL) Inserter) to an existing, already cleared device. The tests conducted are non-clinical and relate to the new instrument and reprocessing instructions, not to clinical performance in terms of disease diagnosis or treatment effectiveness based on specific measurable criteria.
Here's a breakdown of what can be inferred from the document regarding the "study" (non-clinical tests) that proves the device meets the "acceptance criteria" (substantial equivalence):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device "Performance" (Non-Clinical Assessments) |
|---|---|
| Indications for Use: Identical to predicate device. | The subject and predicate CLYDESDALE® Spinal System devices are "identical in terms of indications for use." |
| Intended Use: Identical to predicate device. | The subject and predicate CLYDESDALE® Spinal System devices are "identical in terms of... intended use." |
| Performance Specifications: Identical to predicate device. | The subject and predicate CLYDESDALE® Spinal System devices are "identical in terms of... performance specifications." |
| Technological Characteristics: Identical to predicate device (for the core implant). | The subject and predicate CLYDESDALE® Spinal System devices are "identical in terms of... technological characteristics." The dimensional modifications for the new DL Inserter were assessed per internal processes. |
| Safety and Effectiveness: No new questions raised compared to predicate. | Non-clinical tests included assessment of dimensional modifications and cleaning and sterilization for the new DL Inserter, to ensure appropriate instructions. The conclusion is that equivalence is supported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes non-clinical engineering and cleaning/sterilization assessments related to a new instrument, not a clinical study on a patient test set. No patient data was used.
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. No expert ground truth establishment for a patient test set was performed as part of this submission. The "ground truth" for demonstrating substantial equivalence relies on comparing the new instrument and its reprocessing to internal company standards and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process 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. This document concerns a spinal implant system with a new instrument, not an AI or imaging device subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" for this submission is based on engineering specifications, material properties, and established sterilization/reprocessing protocols, demonstrated through non-clinical laboratory testing.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set ground truth was established.
In summary: The provided document is a 510(k) (Premarket Notification) for a relatively minor modification to an already cleared medical device (adding a new inserter instrument). The "study" referenced is a series of non-clinical assessments to ensure that the new instrument and its reprocessing instructions meet established safety and performance requirements and do not alter the substantial equivalence of the overall system to its predicates. It explicitly states: "The subject and predicate CLYDESDALE® Spinal System devices are identical in terms of indications for use, intended use, performance specifications, and technological characteristics."
§ 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.