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510(k) Data Aggregation
(56 days)
The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).
The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.
The provided FDA approval letter heavily focuses on the regulatory and administrative aspects of the device, primarily confirming its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about a study proving specific acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance (MRMC), or detailed clinical trial information.
The document discusses the mechanical performance of the Arthrex Spine Compression FT Screw, which is a physical medical device (a screw for spinal fixation), not a software or AI-driven diagnostic tool. Therefore, many of the requested points (e.g., sample size for test set, ground truth for test set, number of experts, MRMC study, standalone algorithm performance, training set details) are not applicable to the type of device described in this FDA letter.
However, based on the information provided, I can infer and state what is available regarding the device's performance demonstration:
Device: Arthrex Spine Compression FT Screw
Purpose of Submission: To obtain clearance for the Arthrex Spine Compression FT Screws for spine indications, demonstrating substantial equivalence to predicate devices.
Type of Device: A physical, implantable medical device (a screw for spinal fixation), not an AI/software diagnostic tool.
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a physical device, the "acceptance criteria" discussed are related to its mechanical performance and safety for implantation and MR compatibility, not diagnostic accuracy or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Axial Push-out (per ASTM F2193 Annex 4) | Demonstrated performance substantially equivalent to predicate devices. |
| Static Cantilever Bending (per ASTM F2193 Annex 4) | Demonstrated performance substantially equivalent to predicate devices. | |
| MR Compatibility | Magnetically Induced Displacement Force | Maximum mass of subject device is less than worst-case predicate, thus not representing a new worst-case. |
| Magnetically Induced Torque | Maximum mass of subject device is less than worst-case predicate, thus not representing a new worst-case. | |
| Radiofrequency (RF) Induced Heating (per ASTM F2182-19) | Evaluated, specific results not detailed but implied acceptable for clearance. | |
| Image Artifact (per ASTM F2119-13) | Evaluated, specific results not detailed but implied acceptable for clearance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for mechanical or MR compatibility testing. These are typically bench tests following established standards, not patient-based test sets.
- Data Provenance: The studies are described as "non-clinical testing" conducted by Arthrex. This implies in-house laboratory testing. Not applicable to country of origin, retrospective/prospective data as these are not clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for mechanical and MR compatibility tests is defined by the test standards (e.g., ASTM F2193, F2182-19, F2119-13) and physical measurements, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation, not for bench testing of mechanical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is designed to assess human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is a surgical implant, not a diagnostic AI tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- For mechanical testing: Engineering specifications and direct physical measurements according to validated test methods (ASTM standards).
- For MR compatibility: Measurements against established safety limits and comparisons to predicate devices, verified through standardized test methods (ASTM standards) and in-vivo electromagnetic simulation.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use a training set as it is not an AI/machine learning product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Important Note:
The letter does mention, "A clinical literature summary was provided to support the expansion of indications." This indicates that existing clinical data from published literature was used to support the broadened indications for use of the device, rather than a new, dedicated clinical trial being conducted for this 510(k) submission. However, details of this literature review are not provided in the letter.
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(90 days)
The Arthrex KreuLock Compression Screws (2.0-3.0 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.
The Arthrex KreuLock Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex Compression FT Screws (2.0-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Compression FT Screws (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur and fibula.
The Arthrex KreuLock Compression Screws are a family of screws that are offered in a diameter range of 2.4 to 4.5 mm, length range of 10 to 80 mm, in a fully threaded design, solid, and locking design. The Arthrex KreuLock Compression Screws are intended to be used with plates in the same applications as existing Arthrex Low Profile Screws. Those plates remain unchanged. The Arthrex KreuLock Compression Screws are manufactured from either Titanium or Stainless Steel materials and are available in straight or variable angle configurations. The screws are sold sterile or non-sterile and single-use.
The Arthrex Compression FT Screws are a family of screws that are offered in a diameter range of 2.8 to 7.0 mm, length range of 8 to 140 mm, in a fully threaded and cannulated design. The Arthrex Compression FT Screws are manufactured from Titanium. The screws are sold sterile or non-sterile and single-use.
This document describes the premarket notification (510(k)) for Arthrex Compression Screws (K201132). The primary focus of the performance data section is mechanical testing to demonstrate substantial equivalence to predicate devices, rather than a study involving a diagnostic AI device or human-in-the-loop performance. Therefore, most of the requested information (related to AI acceptance criteria, expert ground truth, MRMC studies, etc.) is not applicable to this submission.
However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the study performed:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Arthrex Compression Screws are based on demonstrating "statistical equivalence" to predicate devices in mechanical performance. The reported performance is that the device meets these criteria, showing substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Statistical equivalence to predicate devices for: | |
| - Push-out strength | The submitted mechanical testing data demonstrates that the push-out strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Insertion torque/failure torque | The submitted mechanical testing data demonstrates that the torque of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Compression strength | The submitted mechanical testing data demonstrates that the compression strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| MR Compatibility: Compliance with specified ASTM standards for: | Conducted per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM F2182-11a (RF Heating). (The text states these tests were "conducted," implying they met the standards for MR compatibility without providing specific numerical results, usually indicating successful completion as per regulatory expectations.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). Mechanical testing typically involves a set number of samples per configuration (e.g., diameter, length, material) to achieve statistical significance.
The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" because this is mechanical testing, not a clinical study involving human patient data. It's an engineering test performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of mechanical testing, is established by scientific principles and validated testing methodologies, not by expert human interpretation. The "truth" is the measured mechanical property.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or subjective assessment that requires adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This is a mechanical device, not an AI or imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screws), not an algorithm.
7. The type of ground truth used
The ground truth for this study is derived from:
- Physical measurements: The actual measurements of push-out force, insertion/failure torque, and compression strength.
- Standardized testing methods: Adherence to established mechanical testing standards (e.g., for strength, torque) and specific ASTM standards for MR compatibility.
- Statistical comparison: The performance is compared statistically to the known performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of mechanical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for mechanical testing.
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