(103 days)
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate. supplemental fixation must be used.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.
The provided text is a 510(k) summary for a medical device (Cervical Spine Truss System - CSTS). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing (mechanical and material testing, and finite element analysis).
It's crucial to understand that 510(k) submissions for devices like the CSTS (intervertebral body fusion devices) typically do not involve clinical studies with human participants in the same way that software-as-a-medical-device (SaMD) or drug trials do. Therefore, the concepts of "acceptance criteria for device performance studies," "sample sizes for test sets (in a clinical context)," "expert adjudication of ground truth," "MRMC studies," "standalone algorithms," and "training sets for AI models" as described in your prompt, are not applicable to this type of regulatory submission or the information contained within this document.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing that verifies the mechanical integrity and safety of the implant.
Here's how to address your prompt based only on the provided text, while clarifying the differences:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for the mechanical tests in a tabular format, nor does it provide specific numerical "reported device performance" values. Instead, it states that the tests were completed "per the following standards" (ASTM F2077, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2051, and "accepted industry standard" for Expulsion Testing) and that the results "show that the strength of the CSTS interbody and CSTS Interbody with an Integrated Plate is sufficient for its use and is substantially equivalent to legally marketed predicate devices."
Table: Non-Clinical Performance Testing and Outcomes
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Summary) |
|---|---|
| Meets ASTM F2077 for Static Axial Compression | Strength sufficient for use; substantially equivalent to predicates |
| Meets ASTM F2077 for Static Compression Shear | Strength sufficient for use; substantially equivalent to predicates |
| Meets ASTM F2077 for Static Torsion | Strength sufficient for use; substantially equivalent to predicates |
| Meets ASTM F2077 for Dynamic Axial Compression (With and Without Integrated Plate) | Strength sufficient for use; substantially equivalent to predicates |
| Meets ASTM F2077 for Dynamic Compression Shear (With and Without Integrated Plate) | Strength sufficient for use; substantially equivalent to predicates |
| Meets ASTM F2077 for Dynamic Torsion (With and Without Integrated Plate) | Strength sufficient for use; substantially equivalent to predicates |
| Meets Screw Pushout Testing (per accepted industry standard) | Strength sufficient for use; substantially equivalent to predicates |
| Meets Expulsion Testing (per accepted industry standard) | Strength sufficient for use; substantially equivalent to predicates |
| Validated Finite Element Analysis (FEA) demonstrating non-inferiority to existing devices | Worst-case CSTS device for each endplate geometry is not a new worst-case compared to previously tested CSTS devices. |
| Meets ASTM F2119 for MR Image Artifact | Results support substantial equivalence to predicates for MR compatibility. |
| Meets ASTM F2182 for MR Induced Heating | Results support substantial equivalence to predicates for MR compatibility. |
| Meets ASTM F2213 for MR Induced Torque | Results support substantial equivalence to predicates for MR compatibility. |
| Meets ASTM F2051 for MR Induced Displacement Force | Results support substantial equivalence to predicates for MR compatibility. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of surgical cases or patient data, as this is not a clinical study. For mechanical testing, "sample size" refers to the number of physical devices or components tested, which is not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. The "data" refers to results from laboratory mechanical and MR compatibility testing, and finite element analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable as the "ground truth" for a mechanical device like this is established by adherence to engineering standards and validated models, not by expert consensus on clinical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable in this context.
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
- An MRMC study is not applicable as this is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This concept is not applicable as this is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" (or verification of performance) for this device relies on:
- Adherence to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion device mechanical testing and MR compatibility.
- Validated Finite Element Analysis (FEA), which is a computational method used to predict how a product reacts to real-world forces, heat, vibration, etc.
- Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics (indications for use, materials, function, sizes) and performance testing.
8. The sample size for the training set
- This concept is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This concept is not applicable as this is not an AI/machine learning device.
In summary: The provided document is a regulatory submission for a physical medical implant. Its "acceptance criteria" and "proof" relate to meeting established engineering and material standards, and demonstrating substantial equivalence to similar devices already on the market, rather than clinical efficacy studies involving human participants or AI performance metrics.
§ 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.