Search Results

The TRUSS™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or failed previous spine surgery.

The TRUSS™ Thoracolumbar Plate System consists of rigid and compression plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral bodies of the thoracolumbar spine (T1-L5). Implants are composed of titanium allov, as specified in ASTM F136. F1295 and F1472.

The provided text describes a 510(k) summary for the TRUSS™ Thoracolumbar Plate System. It focuses on establishing substantial equivalence to predicate devices through mechanical testing. The document highlights the device's indications for use and its regulatory classification.

However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance in a clinical context, or details about the methodological aspects requested such as sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/device performance evaluation.

The "Basis of Substantial Equivalence" section explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates that the evaluation for this device was primarily based on benchtop mechanical testing to demonstrate performance similar to predicate devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot provide the requested information in the format of the table and detailed points, as the input document does not contain this type of data.

To provide the requested details, a document describing a clinical study or performance evaluation with specific acceptance criteria, test sets, expert reviews, and ground truth methodologies would be necessary.

Ask a specific question about this device

The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

The provided text describes a medical device, the "CITADEL™ Anterior Lumbar Plate System," and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to predicate devices through mechanical testing. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not found: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented." However, it does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the explicit performance results of the CITADEL™ device against these criteria. It only asserts that the device is "similar" to predicate devices in "technical characteristics, performance, and intended use."

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/Not found: This device is a mechanical orthopedic implant, not an AI or algorithm-based diagnostic tool. Therefore, concepts like a "test set" with data provenance (country, retrospective/prospective) are not relevant in the context of the device described here. Mechanical testing typically uses physical samples of the device components. The document does not specify the number of samples used for the mechanical tests.

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 using expert consensus is relevant for diagnostic performance studies, not for the mechanical testing of an implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable: Adjudication methods are relevant for expert review in diagnostic studies, not for mechanical testing.

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 a mechanical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable: This is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable: For mechanical devices, performance is typically measured against established engineering standards (e.g., ASTM standards) rather than clinical ground truth types like pathology or outcomes data in the context of an AI model's performance. The "ground truth" here would be the physical properties and mechanical behavior of the device under test, compared to relevant standards or predicate devices.

8. The sample size for the training set

• Not applicable: This device is a mechanical implant and does not involve a "training set" in the sense of machine learning.

9. How the ground truth for the training set was established

• Not applicable: As above, this concept does not apply to a mechanical implant.

In summary, the provided document relates to a 510(k) submission for a mechanical spinal implant. It confirms that mechanical testing was performed according to a guidance document for spinal systems. However, it does not offer the detailed information requested about acceptance criteria and a study design that would be relevant for an AI/algorithm-based medical device.

Ask a specific question about this device