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The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.

Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.

The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Medline UNITE® Ankle Fusion Plating System) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing.

The document explicitly states:

• "This section does not apply. No animal testing was performed."
• "This section does not apply. No clinical testing was performed."
• "Summary of Clinical Testing: Not applicable."

Therefore, there is no information regarding:

• Acceptance criteria and reported device performance related to a clinical study.
• Sample size used for the test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, and nonunions of the distal tibia and fibula such as:

• · Medial Malleolar Fractures
• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Vertical Shear Fractures of the Medial Malleolus
• · Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures

In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric (adolescent and child) patients.

The Medline UNITE® Medial Malleolar Peg Plate System consists of implants manufactured from Titanium Alloy (Ti-6Al-4V ELI). The system includes plates offered in two sizes. The plates can accommodate Ø2.7mm. Ø3.5mm. and Ø4.0mm locking and non-locking screws and Ø2.0mm locking pegs. The system also includes reusable instrumentation necessary to implant the plates, screws, and pegs, e.g. plate inserter. wire sleeve.

This FDA 510(k) premarket notification describes the Medline UNITE® Medial Malleolus Peg Plate System. It is important to note that this document is for a medical device (a bone fixation system) and not for an AI/software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study aspects related to AI/SaMD (like ground truth, expert consensus, MRMC studies, training set size, etc.) are not applicable to this submission.

The "acceptance criteria" for a medical device like this are primarily based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and biocompatibility testing.

Here's a breakdown of the information provided, tailored to a mechanical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set: No discrete "test set" in the context of clinical data for AI/SaMD. The evaluation is based on engineering analysis and material testing.
• Data Provenance: The data comes from bench testing (engineering analysis) comparing the subject device's design, materials, and mechanical properties to predicate devices. This is not patient-specific data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. This is a medical device, not an AI/SaMD. "Ground truth" for an AI algorithm, established by experts, is not relevant here. The "truth" is established through material standards, engineering principles, and mechanical testing results.

4. Adjudication Method for the Test Set

• Not applicable. No human interpretation or adjudication of an "AI output" is involved. The evaluation is based on objective engineering comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/SaMD. MRMC studies are used to assess the impact of AI on human reader performance.

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

• No. This is not an AI/SaMD. A "standalone algorithm" is not relevant for a bone fixation system.

7. The type of ground truth used

• Not applicable in the context of AI/SaMD. For this medical device, the "ground truth" for demonstrating safety and effectiveness relies on:
  • Material Standards: Adherence to established ASTM/ISO standards for titanium alloy.
  • Engineering Principles: Calculations and analysis demonstrating equivalent or superior mechanical performance compared to the predicate.
  • Predicate Device Data: Leveraging existing safety and effectiveness data from legally marketed predicate devices with known performance.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/SaMD.

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

• Not applicable. There is no "training set" or its associated ground truth for this type of medical device submission.

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Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.

The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits

This document is a 510(k) premarket notification for the Medline UNITE® Calcaneal Fracture Plating System. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria through a study involving AI. Therefore, the requested information elements related to AI/algorithm performance and clinical study outcomes cannot be extracted from this document.

The document primarily describes a medical device, its indications for use, and a comparison of its technological characteristics to a predicate device. The performance testing outlined is largely bench testing to demonstrate mechanical equivalence, not clinical effectiveness studies.

Here's what can be extracted based on the provided document:

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

The document does not provide explicit acceptance criteria in a quantitative sense for performance metrics like sensitivity, specificity, or image quality, as it's not and AI device undergoing such validation. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must perform equivalently to a legally marketed predicate device.

2. Sample sized used for the test set and the data provenance

Not applicable. The "test set" in this context refers to physical devices undergoing mechanical testing, not a dataset for an AI algorithm. The document mentions "Single Cycle 4-Point Bend Testing" and "Bending Fatigue Testing," which involve physical samples of the plates. The document does not specify the exact number of plates tested in these bench tests, nor does it specify data provenance as it would for a clinical study with patient data.

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

Not applicable. Ground truth for AI algorithms is not relevant here as this is a physical medical device. The "ground truth" for the performance tests is derived from standardized mechanical testing protocols (ASTM F382).

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically for clinical studies where expert consensus is needed. For mechanical testing, the results are objectively measured per established ASTM standards.

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 not an AI device, and therefore, an MRMC study involving human readers and AI assistance was not performed. The document explicitly states: "Performance Testing (Clinical) This section does not apply. No clinical testing was performed." and "Summary of Clinical Testing Not applicable."

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

No. This is not an AI device.

7. The type of ground truth used

For the bench testing, the "ground truth" or reference for comparison is the performance of the legally marketed predicate device as measured by the specified ASTM standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm, so there is no training set.

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

Not applicable. There is no AI algorithm.

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