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The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.

The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples.

The requested information about the acceptance criteria and study proving the device meets them is not available in the provided text. The document is an FDA 510(k) clearance letter for a medical device (Medline UNITE® REFLEX® Nitinol Staple Kit), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical or standalone performance.

The provided text only mentions:

• Summary of Non-Clinical Testing (Bench):
  • Elastic Static Bend and Constant Amplitude Bending Fatigue Testing per ASTM F564
  • Pullout Strength Testing per ASTM F564
  • Corrosion Susceptibility Testing per ASTM F2129
  • Bacterial endotoxin testing using the Limulus Amebocyte Lysate (LAL) kinetic chromogenic assay, demonstrating the device meets the recommended maximum endotoxin level of 20 EU per device.
• Performance Testing (Animal): This section does not apply. No animal testing was performed.
• Performance Testing (Clinical): This section does not apply. No clinical testing was performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given document.

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The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.

The Medline UNITE® REFLEX® Nitinol Staples are manufactured from nickel titanium alloy (Nitimol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The system includes staples offered in a range of sizes from 8mm x 20mm x 20mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in different bridge lengths and include 2-leg and 4-leg staples. The system also includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drills, locating pins, staple inserter, and tamp.

The document describes the Medline UNITE® REFLEX® Nitinol Staple System and its substantial equivalence to a predicate device. The information is limited to non-clinical bench testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the bench tests. The tests performed are non-clinical (bench tests). No information is provided regarding the country of origin of data or whether it was retrospective or prospective.

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

Not applicable. The ground truth for this device is established through engineering analysis and bench testing, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical bench test.

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

No. This is a non-clinical bench test for a medical device (staple system), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (staple system), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering analysis: Comparing the subject device's design and expected mechanical performance to the predicate device.
• Bench testing: Controlled laboratory tests (e.g., bending, pullout, corrosion) against established ASTM standards and FDA guidance.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device undergoing non-clinical testing, not a machine learning model.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Study Proving Device Meets Acceptance Criteria

The study proving the device meets its acceptance criteria is a series of non-clinical bench performance tests and engineering analyses.

• Engineering Analysis: An initial engineering analysis was performed to determine that the subject Medline UNITE® REFLEX® Nitinol Staples do not represent a new worst-case in terms of bending and pullout performance when compared to the previously cleared predicate device (K210482). A further engineering analysis was conducted to identify the worst-case staple for corrosion susceptibility.
• Performance Testing (Bench):
  • Bending Strength/Stiffness and Pullout Performance: Engineering analysis was used to compare these characteristics of the subject staple to the predicate staples (K210482) per ASTM F564. The results indicated substantial equivalence.
  • Corrosion Susceptibility Testing: This was conducted per ASTM F2129 and the FDA guidance document "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol." The testing ensured that the proposed staples met predefined acceptance criteria. All samples achieved an electrostatic breakdown potential exceeding the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility.

Conclusion of the Study: Medline Industries, LP concluded that the subject Medline UNITE® REFLEX® Nitinol Staple System is as safe and effective for its intended use as the predicate device (K210482) based on these non-clinical tests and analyses. No animal or clinical testing was performed.

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The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.

The Medline UNITE® REFLEX™ Dynamic Discs are manufactured from nickel titanium alloy (nitinol). The discs utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The discs are offered in various diameters and thicknesses to be used in conjunction with screws of various diameters.

The provided text is related to a 510(k) premarket notification for a medical device (Medline UNITE® REFLEX™ Dynamic Discs). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical or comparative effectiveness study as would be seen for an AI/ML medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or AI/ML context. It focuses instead on non-clinical (bench) testing to support material and design equivalency.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device described (Dynamic Discs) is a metallic bone fixation appliance, not an AI/ML-driven diagnostic or analytical tool. Therefore, there are no AI/ML performance metrics, acceptance criteria, or studies (like MRMC or standalone performance) to report.
• Focus on Substantial Equivalence: The 510(k) pathway is primarily about demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technological characteristics, intended use, and performing non-clinical (bench) tests to ensure safety and performance are comparable, rather than conducting large-scale clinical trials with specific performance endpoints and expert ground truth establishment.
• Non-Clinical Testing Only: The "Summary of Non-Clinical Testing" section describes tests like transformation temperature (ASTM F2004), galvanic corrosion (ASTM F3044), and corrosion susceptibility (ASTM F2129). These are material and safety tests, not performance studies in a clinical setting determining diagnostic accuracy or human reader improvement.
• "Summary of Clinical Testing: Not applicable.": This explicitly states that clinical testing was not performed or required for this submission, further reinforcing that there won't be data on human reader improvement or standalone diagnostic performance.

In summary, none of the specific bullet points regarding acceptance criteria, study details (sample sizes, data provenance, expert adjudication, MRMC, standalone performance, ground truth), or training set information are applicable or present in this 510(k) submission for the Medline UNITE® REFLEX™ Dynamic Discs.

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