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510(k) Data Aggregation
(177 days)
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
- trauma (including fracture or dislocation);
- spinal stenosis;
- cervical myelopathy;
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor:
- pseudoarthrosis; and/or
- failed previous fusion
The Cardiff™ Anterior Cervical Plate (ACP) System is interior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws into the vertebral body of the cervical spine using an anterior approach.
The provided text describes a Special 510(k) submission for the Cardiff™ Anterior Cervical Plate (ACP) System. This submission is for a product line modification of an already cleared device, not an AI/ML powered medical device, and therefore does not contain information about acceptance criteria, device performance metrics, or study details typically found in submissions for such devices.
The key points from the provided text are:
- Device Type: Anterior Cervical Plate System (a physical implant for spinal fixation).
- Purpose of Submission: Special 510(k) for manufacturing process changes and addition of implant variations to an already cleared device.
- Substantial Equivalence: The submission asserts substantial equivalence to previously cleared Cardiff™ ACP System (K083338) and Sonoma™ ACP System (K032368).
- No New Clinical/Non-Clinical Testing: The document explicitly states: "No additional non-clinical testing was required to demonstrate equivalence with the previously cleared Cardiff™ or Sonoma ACP Systems." and "Engineering and Clinical rationale verified that no additional risks were introduced into the system."
Given this, I cannot provide the requested information as it pertains to AI/ML device studies (acceptance criteria, performance, sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets). This submission is for a modification to a physical implant where the changes are deemed not to alter the fundamental scientific technology and thus did not require new performance studies.
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(82 days)
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, trauma (including fracture or dislocation), spinal stenosis, cervical myelopathy, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
The Cardiff™ Anterior Cervical Plate (ACP) System is intended for anterior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium 6AL-4V ELI and Nitinol SE508. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The provided document describes a 510(k) premarket notification for a medical device called the Cardiff™ Anterior Cervical Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on meeting specific performance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design for device performance, ground truth establishment, expert adjudication, and AI-related metrics (MRMC, standalone performance, training sets) is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This submission is based on demonstrating substantial equivalence, not on pre-defined clinical acceptance criteria. The performance data provided relates to mechanical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | Mechanical testing results indicated that Cardiff™ possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s). |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No clinical test set data is described in this 510(k) summary. The performance data is based on mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. No clinical test set and thus no ground truth established by experts is described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not Applicable. No clinical test set and thus no adjudication method is described in this 510(k) summary.
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 device is a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
Not Applicable. No clinical ground truth is described. The relevant "ground truth" for this submission are the established mechanical properties required for a device of this type and the existing predicate devices.
8. The Sample Size for the Training Set
Not Applicable. As a physical device, there is no "training set" in the context of an AI algorithm or statistical model.
9. How the Ground Truth for the Training Set was Established
Not Applicable. There is no "training set" or associated ground truth in this context.
Summary of what was reported:
The Cardiff™ Anterior Cervical Plate System's acceptance was based on demonstrating substantial equivalence to existing predicate devices through:
- Mechanical Testing Results: The document states, "Mechanical testing results indicated that Cardiff™ possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s)." This implies that the mechanical properties (e.g., strength, fatigue resistance) were tested and found to be comparable to or within acceptable limits for the intended use, aligning with the properties of the predicate devices.
- Comparison to Predicate Devices: The device was compared to the following commercially available predicate devices:
The FDA determined that clinical data was not required for this device, which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means (like mechanical testing and comparison to existing technology).
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