Search Results

The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, deformity corrections, osteotomies, and non-unions of small bones of the feet.

Specific examples include:

First metatarsal osteotomies for hallux valgus and hallux varus correction including:

Opening/Closing base wedge osteotomies, Distal and Proximal Chevron osteotomies, Ludloff Osteotomy,

Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux rigidus and/or hallux valgus, Revision MTP Fusion Revision of failed first MTP Arthroplasty implant

Metatarsal and Phalanges: Metatarsal and Phalanges fractures and osteotomies;

Mid / Hindfoot Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture

Mid / Hindfoot Fusions:

Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

Mid / Hindfoot Osteotomies (Deformity Corrections):

Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy

The TriMed ASET Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium and titanium alloy. Implant offerings are as followed: 1st MTP Osteotomy plates, H-Plate, Talonavicular Plate, Calcaneal Slide Osteotomy Plate, Evans Osteotomy Plate, Medial Column Fusion Plate, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and non-locking screws are also included.

This FDA 510(k) premarket notification letter concerns the TriMed ASET Foot Plating System. It does not contain information about acceptance criteria or specific studies proving a device meets them in the context of an AI/software device. Instead, it details the regulatory approval of a hardware medical device (bone fixation plates and screws).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as this document does not contain that type of data for an AI/software component.

The document states: "Clinical studies were not conducted for the subject devices." This confirms that there's no clinical performance data for this submission that would involve AI/software performance metrics.

The safety and performance of the TriMed ASET Foot Plating System were evaluated through non-clinical testing:

• Study: The implants were tested according to the recommendations in the FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff."
• Methodology: Static and dynamic four-point bending tests were conducted per ASTM F382-17.
• Specific Plate Tested: The TriMed ASET Calcaneal Sliding Osteotomy plate was specifically mentioned for static bending.
• Conclusion: The testing showed that the loading was greater or equal to the referenced predicate device. This suggests the acceptance criterion was likely non-inferiority or superiority in mechanical strength compared to the predicate device.

There is no information in the provided text regarding any AI or software component, nor any associated acceptance criteria, specific performance metrics for AI, sample sizes, ground truth, or multi-reader studies.

Ask a specific question about this device

The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:

• Opening/closing base wedge osteotomies,
• Distal and proximal chevron osteotomies,
  Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
  Arthrodesis of the first metatarsophalangeal joint (MTP) including:
• Primary MTP fusion due to hallux rigidus and/or hallux valgus,
• Revision MTP fusion,
• Revision of failed first MTP arthroplasty implant,
  Metatarsal and Phalanges:
• Metatarsal and phalanges fractures and osteotomies;
  Mid / Hindfoot Fusions:
• Tarsometatarsal (TMT) fusions/stabilization,
• Intercuneiform fusions.

The TriMed ASET™ Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium alloy. Implant offerings are as followed: 15 MTP fusion plates, Lapidus (With and without hooks) plates, Universal Straight plates, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and nonlocking screws are also included.

The provided text describes a 510(k) premarket notification for a medical device called the "TriMed ASET™ Foot Plating System." This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity in an AI/imaging context.

The document discusses mechanical and biological acceptance criteria for the physical device (plates and screws), not performance criteria related to a diagnostic or AI-driven medical device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.

Here's how the available information relates to your request:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes mechanical testing of physical implants, not a clinical study involving human data or a test set in the context of an AI/imaging device. The "test set" would refer to the physical samples of the plates and screws used in the mechanical tests. The document does not specify the number of physical samples tested.

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)

• Not applicable. Ground truth in this context refers to the measured mechanical properties. These are established through standardized engineering tests, not human expert consensus.

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

• Not applicable. This pertains to consensus among experts in interpreting clinical data, which is not relevant for mechanical 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. This is a mechanical device, not an AI or imaging device that would involve human readers or MRMC studies.

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

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for the device's performance is based on engineering standards and mechanical testing results (e.g., measured strength, fatigue life, torque, pullout force) as compared to the predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Ask a specific question about this device