(77 days)
The DePuy Motech Profile Anterior Thoracolumbar Plate System is intended for use in the treatment of thoracic and 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 a failed previous spine surgery.
The DePuy Motech Profile Anterior Thoracolumbar Plate System consists of 10 thoracolumbar and 12 high thoracic plates of various lengths (40-120mm); 9 cancellous screws in varying lengths (20-60mm); 8 cancellous bolts in progressive lengths (25-60mm) with locking nuts and screws; and four bone graft screws of different lengths (15, 20, 25, 30mm).
The anterior thoracolumbar plates are implanted using 2 cancellous bolts placed through the plate's bolt slots and fixed with locking nuts and screws, 2 cancellous screws placed through the plate's threaded screw holes, and an optional graft screw which can be placed through the plates's center slot to provide fixation between the plate and a strut graft if desired.
The high thoracic plates are implanted using 4-6 cancellous screws, placed through the plate's screw holes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Motech™ Profile™ Anterior Thoracolumbar Plate System.
It's important to note that the provided document is a 510(k) summary for a medical device (spinal plate system), not a software or AI/ML device. Therefore, the concepts of human readers, AI assistance, ground truth establishment through expert consensus or pathology for an algorithm, training sets, and test sets in the context of AI/ML performance are not directly applicable to this type of submission.
Instead, for a hardware medical device like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing and comparison of materials, design, and intended use.
Acceptance Criteria and Study for DePuy Motech™ Profile™ Anterior Thoracolumbar Plate System
Given that this is a 510(k) submission for a physical medical device (spinal plate system), the structure of the acceptance criteria and supporting study is different from a software/AI/ML device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Material Equivalence: Manufactured from a material substantially equivalent to predicate devices. | "Both the ATL plates and the MOSS Miami Titanium sub-system are manufactured from Ti-6A1-4V alloy." (Substantially equivalent to MOSS Miami Titanium sub-system). |
| "The major difference between these systems [ATL and Amset ALPS] is that the Amset ALPS plates are manufactured from 316 LVM Stainless Steel." (Acknowledges material difference with Amset, but emphasizes similar design and anterior stabilization intent, likely deemed acceptable given other equivalences). | |
| Design Equivalence: Similar design principles and components for their intended use. | "The DePuy Motech Profile Anterior Thoracolumbar Plate System consists of 10 thoracolumbar and 12 high thoracic plates of various lengths... 9 cancellous screws... 8 cancellous bolts... four bone graft screws." |
| "The designs of the systems are similar" (referring to Amset ALPS). | |
| Intended Use Equivalence: Same indications for use as predicate devices. | "intended for use in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture... tumor, degenerative disc disease... scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery." (Identical or very similar to predicate devices, as stated in the basis for substantial equivalence). |
| Mechanical Performance Equivalence: Fatigue strength and other mechanical properties are at least equivalent to predicate devices. | "Mechanical testing shows that the fatigue strength of the ATL plates is, at least, equivalent to that of both the MOSS Miami Titanium sub-system and the MOSS Miami 4.0mm sub-system." (This is the primary performance criterion for this type of device). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of an "AI test set." For mechanical testing, the "sample size" would refer to the number of devices or components tested. This information is not detailed in the provided 510(k) summary. The summary only states that "Mechanical testing shows..." but does not provide specific sample quantities, test protocols, or raw data.
- Data Provenance: Not applicable in the context of "data provenance" for AI. Mechanical testing is typically conducted in a laboratory setting by the manufacturer, following standardized testing methods (e.g., ASTM standards for orthopedic implants).
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):
- This concept is not applicable to the submission of this physical medical device. "Ground truth" for this device is established through objective mechanical testing against established industry standards and comparison to predicate devices, not subjective expert judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to this device. Adjudication methods are typically used for establishing ground truth in clinical studies or for evaluating human performance, not for mechanical device 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, where human readers interact with AI. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This refers to the performance of an AI algorithm alone. The DePuy Motech Profile Anterior Thoracolumbar Plate System is a physical device, not an algorithm. Its "standalone performance" is its mechanical integrity and ability to fulfill its intended function when implanted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical medical device, the "ground truth" (or basis for acceptance) is established by:
- Mechanical Test Results: Objective measurements of fatigue strength and other mechanical properties, compared against those of predicate devices (and likely against internal specifications or relevant ASTM/ISO standards).
- Material Specifications: Verification that the materials used (e.g., Ti-6A1-4V alloy) meet established standards and are equivalent to predicate devices.
- Design Specifications: Comparison of the physical design and components to predicate devices.
- Intended Use/Indications: Ensuring the proposed indications for use are consistent with those of predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" for a physical medical device in the context of an AI/ML workflow.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for one.
Summary of the study that proves the device meets the acceptance criteria (based on the provided text):
The "study" presented here to prove the device meets acceptance criteria is primarily a comparison of the new device to legally marketed predicate devices (DePuy Motech MOSS Miami Titanium Spinal System, DePuy Motech MOSS Miami 4.0mm Spinal System, and Amset Anterior Locking Plate System) to establish substantial equivalence.
The key evidence provided is:
- Material Comparison: Both the new ATL plates and the MOSS Miami Titanium sub-system are made from Ti-6A1-4V alloy.
- Design Similarities: The ATL plates and Amset ALPS plates have similar designs for anterior stabilization.
- Intended Use: All compared systems are intended for anterolateral fixation to the thoracic and thoracolumbar spine (T1-L5) for the same indications.
- Mechanical Testing: Crucially, "Mechanical testing shows that the fatigue strength of the ATL plates is, at least, equivalent to that of both the MOSS Miami Titanium sub-system and the MOSS Miami 4.0mm sub-system." This mechanical testing is the primary "study" that directly addresses a performance "acceptance criterion" for a physical implant.
The submission successfully argued that the new device is substantially equivalent to the predicates, allowing it to be marketed under a 510(k) pathway without requiring a full Premarket Approval (PMA) process.
§ 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.