(93 days)
The PLYMOUTH™ 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, lordosis, spinal stenosis, or failed previous spine surgery.
The PLYMOUTH™ Thoracolumbar Plate System consists of rigid 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 body of the thoracolumbar spine (T1-L5). These implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
This document is a 510(k) summary for the PLYMOUTH™ Thoracolumbar Plate System. It describes the device, its indications for use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that mechanical testing was conducted "in accordance with 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 to demonstrate substantial equivalence to the predicate system." It lists the types of tests: "static and dynamic compression bending and static torsion."
While the document indicates what tests were performed and which guidance document they followed, it does not explicitly state specific numerical acceptance criteria (e.g., minimum strength, maximum deformation) or the quantitative results of these tests for either the new device or the predicate. It only broadly asserts that the device is "similar to the predicate devices with respect to technical characteristics, design, materials, performance, and intended use" and that the information "supports substantial equivalence."
Therefore, a table with specific numbers for acceptance criteria and reported performance cannot be fully constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes mechanical testing of the device itself, not clinical testing on human subjects. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as they relate to human patient data are not applicable here. The "test set" refers to the physical devices tested in the lab. The sample size for these mechanical tests is not explicitly stated in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable. Ground truth, in the context of expert consensus, typically refers to clinical data interpreted by medical professionals. This document focuses on mechanical performance of a medical device in a laboratory setting, not diagnostic or clinical accuracy determined by experts.
4. Adjudication Method for the Test Set:
This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 refer to consensus processes among human reviewers of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers evaluating medical cases (e.g., medical images) to compare the effectiveness of different diagnostic or interventional approaches, often with and without AI assistance. This 510(k) pertains to the mechanical performance of a spinal implant, not a diagnostic or AI-assisted interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This 510(k) is for a physical medical device (thoracolumbar plate system), not for an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation is established by engineering standards and predicate device performance. The mechanical tests (static and dynamic compression bending, static torsion) are designed to assess physical properties and durability against established industry guidance for spinal systems. The "truth" is whether the device meets these mechanical performance expectations and performs "similar" to legally marketed predicate devices.
8. The Sample Size for the Training Set:
This question is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) is for a physical medical device and does not involve an AI or machine learning component.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as point 8.
In summary, the provided document details the mechanical testing of a spinal implant for 510(k) clearance, asserting substantial equivalence to predicate devices based on adherence to FDA guidance. It does not involve clinical studies with human subjects, expert consensus, or artificial intelligence/machine learning components that would necessitate the information requested in many of your questions.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.