(191 days)
The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- mono or bicortical osteotomies
- distal or proximal metatarsal osteotomies
- weil osteotomy
- fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
Not for spinal use.
The Treace Medical Concepts, Inc (TMC) Snap -Off Screw System includes self-drilling and selftapping screws provided in diameters of 2.0mm (lengths 10mm-20mm) and 2.7mm(lengths 8mm-20mm).
The screws are composed of titanium alloy conforming to ASTM F136.
When evaluating medical device submissions, the FDA scrutinizes various aspects, including performance, safety, and substantial equivalence to legally marketed predicate devices. The document provided, a 510(k) summary for the Treace Medical Concepts (TMC) Snap-Off Screw System (K183363), outlines the device's characteristics and the testing conducted to support its substantial equivalence.
Based on the provided text, the device in question is a bone fixation fastener, specifically the Treace Medical Concepts, Inc (TMC) Snap-Off Screw System. The regulatory classification for this device is Class II, under regulation 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fasteners.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for demonstrating substantial equivalence for this type of device typically involve mechanical performance characteristics that demonstrate the device is as safe and effective as its predicate. Based on the document, the key performance criteria evaluated were:
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| Torsion properties (ASTM F543) | Confirmed to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw. |
| Pull-out properties (ASTM F543) | Confirmed to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw. |
The document states, "This testing confirmed the subject screws to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw." This implies that the performance of the TMC Snap-Off Screw System fell within the acceptable range or met the same performance standards established by the predicate device for torsion and pull-out strength.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the sample size used for the performance testing (torsion and pull-out). It only mentions that performance testing was performed.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission to the US FDA, the testing would generally be expected to follow US standards, but the origin of the data samples (e.g., specific manufacturing batches) is not detailed. The mechanical testing described is typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For the mechanical performance testing described (torsion and pull-out), the "ground truth" is established by physical measurements against recognized ASTM standards (ASTM F543), not by expert interpretation. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (e.g., medical imaging) does not apply here.
4. Adjudication Method for the Test Set:
- Not Applicable. As the ground truth is established through standardized mechanical testing, there is no need for an adjudication method as would be used in a study involving human interpretation or clinical endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or implied. The submission focuses on substantial equivalence based on device design, materials, indications for use, and mechanical performance testing against a predicate device. This type of study is more common for diagnostic imaging AI algorithms where human reader performance is a key aspect.
6. Standalone Performance:
- A standalone performance evaluation was conducted in terms of mechanical properties. The torsion and pull-out testing evaluates the intrinsic physical properties of the device (the screws themselves) in a simulated environment, independent of human interaction during surgery or in a clinical setting for outcome. The testing aims to show the device's inherent mechanical strength.
7. Type of Ground Truth Used:
- The ground truth for the performance testing was based on engineering standards and specifications, specifically ASTM F543 for torsion and pull-out properties. The "truth" is whether the device meets or exceeds the mechanical properties demonstrated by the predicate device when tested according to this standard.
8. Sample Size for the Training Set:
- Not Applicable. Since this is a mechanical device, not a machine learning or AI algorithm, there is no "training set" in the context of data used to train a model. The design and manufacturing processes are established based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The device's design is based on established engineering principles and the performance of existing predicate devices.
Summary of Key Findings based on the document:
The 510(k) summary demonstrates substantial equivalence of the TMC Snap-Off Screw System to its predicate devices (Integra SPIN Snap-Off Screw and TMC Compression Screw System) primarily through:
- Comparison of Indications for Use, Design, Dimensions, and Materials: The subject device's features are compared side-by-side with the predicates to show similarity.
- Mechanical Performance Testing: Specifically, torsion and pull-out properties tested according to ASTM F543 were found to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw.
The document does not delve into clinical efficacy studies, multi-reader studies, or large-scale clinical outcome data, as these are generally not required for 510(k) clearance of Class II orthopedic fixation devices when substantial equivalence can be demonstrated through design, material, and mechanical property comparisons to legally marketed predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.