Search Results

The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.

The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

Based on the provided FDA 510(k) Clearance Letter for TriMed® Compression Screws (K243943), here's an analysis of the acceptance criteria and the study proving the device meets them.

It's important to note that this document is for a physical medical device (compression screws), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the typical criteria for AI/ML-based devices (such as ground truth establishment by experts, adjudication, MRMC studies, standalone algorithm performance, training/test set sample sizes for AI, etc.) are not applicable here.

The "study" in this context refers to mechanical testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI model validation.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for bone fixation fasteners like the TriMed® Compression Screws are primarily related to their mechanical properties, material biocompatibility, and intended use as compared to "predicate" devices already on the market. The core concept for a 510(k) clearance is "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance

The submission implies successful completion of these tests, leading to the substantial equivalence determination. |
| Material Compatibility | The materials used (medical grade stainless steel and titanium) must be biocompatible and suitable for long-term implantation in the human body. | "TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium."

The use of "medical grade" materials and comparison to predicate devices (some using stainless steel and titanium, others titanium only) implies conformance to established material safety standards. |
| Design and Principles of Operation | The device's design features, principles of operation, and manufacturing processes should be substantially equivalent to legally marketed predicate devices, ensuring similar safety and effectiveness profiles. | "TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling."

The document specifically discusses the introduction of additional materials (stainless steel) and new screw diameters/lengths, asserting that these differences are "minor and do not raise different questions concerning safety or effectiveness." |
| Intended Use / Indications for Use | The stated indications for use for the device must align with historical use of similar devices and be supported by the device's design and performance. | TriMed® Compression Screws are indicated for "fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot" (Small Screws) and "large bones and large bone fragments" (Large Screws). This aligns with the use of predicate bone fixation fasteners. |
| Predetermined Change Control Plan (PCCP) | The PCCP outlines pre-approved modifications and the testing required to ensure continued safety and effectiveness without requiring new 510(k)s. This demonstrates a proactive approach to managing changes. | The PCCP details planned modifications (new materials, screw head designs, headed screw line extension) and specifies the test methods and validation activities (e.g., ASTM F543-17, FDA guidance, IEC 62366-1) that will be performed for each change. |

Study Details (as applicable to a physical medical device)

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, this refers to the number of components or devices tested. ASTM F543-17 would specify the required number of samples for each mechanical test (e.g., torsional strength, bending strength, fatigue).
• Data Provenance: The document focuses on performance testing (mechanical studies) rather than clinical data from patients. The testing was conducted "in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." This implies the data is generated from laboratory testing of the manufactured devices. No country of origin for data (like patient data) is relevant here, as it's product engineering test data. It's prospective data generation from in vitro testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable (N/A). This is a physical medical device, not an AI/SaMD. "Ground truth" is established by engineering standards (e.g., ASTM F543-17) and direct comparison to the physical properties of predicate devices. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to the specified performance criteria, but their number and specific qualifications for "ground truth" establishment are not detailed in the context of expert consensus on an image or clinical finding.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical/imaging studies, typically for AI models. For mechanical testing, the results are quantitative and objective, measured against predefined standards.

4. 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 (N/A). MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices with human readers interpreting cases. This device is a surgical implant.

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

• Not Applicable (N/A). This criterion is for AI algorithms. The "standalone performance" of these screws refers to their mechanical integrity without human interaction, which is assessed through the mechanical testing mentioned.

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

• Engineering Standards and Predicate Device Performance Data. For a physical implant, "ground truth" for clearance is based on adherence to recognized mechanical engineering standards (e.g., ASTM F543-17) and demonstrating that the device performs equivalently or better than, and poses no new safety concerns compared to, the already cleared predicate devices.

7. The sample size for the training set:

• Not Applicable (N/A). This question is for AI/ML models. There is no "training set" in the context of clearing a physical medical device. The "training" for the device would be its design and manufacturing process, optimized through engineering principles.

8. How the ground truth for the training set was established:

• Not Applicable (N/A). As there's no training set for an AI model, this question is irrelevant here. The design and manufacturing of the screws are based on established biomechanical principles and material science.

In summary, the 510(k) clearance for the TriMed® Compression Screws relies on demonstrating substantial equivalence to predicate devices through a combination of engineering design comparisons, material characterization, and rigorous mechanical performance testing according to well-established standards. The typical criteria for AI/ML devices do not apply to this type of traditional medical device.

Ask a specific question about this device