(29 days)
The Medline UNITE® Ancillary Foot Recon Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty implant
- Flatfoot Osteotomies:
- Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- Medial Displacement Calcaneal Osteotomy (MDCO)
- Midfoot / Hindfoot Fusions:
- LisFranc Arthrodesis and/or Stabilization
- 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusions (NC and 1st TMT)
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
The Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Medline UNITE® Ancillary Foot Recon Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI). The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, 2.7mm, and 4.0mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates, 3.5mm crossplate screws to be used with the dual-mode compression slot(s) in select plates, and 3.7mm and 4.1mm solid Lisfranc screws. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline UNITE® Ancillary Plating System Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.
This is a 510(k) premarket notification for a medical device, the Medline UNITE® Ancillary Foot Recon Plating System. These notifications typically establish substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance in the way a novel AI or diagnostic device might.
Therefore, this document does not contain the detailed information you've requested about acceptance criteria, study methodologies, ground truth establishment, or human reader performance for an AI/diagnostic device.
However, I can extract the information provided regarding the comparison to predicate devices, which serves a similar purpose in a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission of this type, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, particularly regarding material, design, and mechanical performance. The performance is reported relative to the predicate device.
| Device Characteristic | Acceptance Criterion (Implied by Predicate Equivalence) | Reported Device Performance (Medline UNITE® Ancillary Foot Recon Plating System) |
|---|---|---|
| Plates | ||
| Materials | Titanium Alloy (Same as predicate) | Titanium Alloy (Same) |
| Design Configurations | Left and Right (Similar to predicate) | Left and Right, Universal (Similar) |
| Design Features - Plates | Polyaxial Locking up to 15°, Compression Slots (Same as predicate) | Polyaxial Locking up to 15°, Compression Slots (Same) |
| Bending Strength | Not worse than predicate (K151235) | Engineering analysis determined not a new worst-case, substantially equivalent. |
| Pullout Strength | Not worse than predicate (K151235) | Engineering analysis determined not a new worst-case, substantially equivalent. |
| Plating Screws | ||
| Materials | Titanium Alloy (Same as predicate) | Titanium Alloy (Same) |
| Design Features | Locking and Non Locking (Same as predicate) | Locking and Non Locking (Same) |
| Diameters | 2.7mm, 3.5mm (Predicate K151235) | 2.7mm, 3.5mm, 4.0mm (Similar; 4.0mm is new but evaluated) |
| Lengths | 2.7mm: 10-30mm, 3.5mm: 10-60mm (Predicate K151235) | 2.7mm: 10-60mm, 3.5mm: 10-60mm, 4.0mm: 14-60mm (Similar; extended lengths and new diameter evaluated) |
| Axial Pullout Strength | Not worse than predicate (K151235) | Engineering analysis determined not a new worst-case, substantially equivalent. |
| Torsional Yield Strength | Not worse than predicate (K151235) | Engineering analysis determined not a new worst-case, substantially equivalent. |
| LisFranc Screws | ||
| Materials | Stainless Steel (Predicate K081374), Titanium Alloy (Predicate K130319) | Titanium Alloy (Different from K081374, Same as K130319) |
| Design Features | Hex drive, Self-tapping (Predicate K081374), Torx drive, Self-tapping (Predicate K130319) | Torx drive mechanism, Self-Tapping (Similar to K130319) |
| Diameters | 3.7mm, 4.5mm (Predicate K081374), Various (Predicate K130319: 2.0mm-7.5mm) | 3.7mm, 4.1mm (Similar) |
| Lengths | 3.7mm: 20-50mm, 4.5mm: 30-50mm (Predicate K081374), Various (Predicate K130319) | 3.7mm: 20-100mm, 4.1mm: 20-100mm (Similar; extended lengths evaluated) |
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. This submission relies on engineering analyses and comparison to existing predicate device data, not on a new clinical test set with human subjects or a defined image cohort.
- Data Provenance: Not applicable. The "data" used is the existing performance data and designs of the predicate devices.
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. No ground truth was established by human experts for a test set in this context. The determination of substantial equivalence is based on engineering principles and regulatory assessment, typically by engineers and regulatory specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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
Not applicable. This is not an AI/diagnostic device; it is an orthopedic plating system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission revolves around established mechanical and material properties and regulatory requirements for predicate devices.
8. The sample size for the training set
Not applicable. There is no training set for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
Summary of Non-Clinical Testing:
The document states that an engineering analysis was performed to determine that the Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case compared to the predicate Medline Foot Plates and Screws (K151235) for:
- Bending strength (for plates)
- Pullout strength (for plates)
- Axial pullout strength (for screws)
- Torsional yield strength (for screws)
The conclusion was that the new system is substantially equivalent to the predicate device based on these analyses. No animal or clinical testing was performed for this submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.