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The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.

The provided text is a 510(k) summary for the "AFT™ Greater Tuberosity Fracture System," which is a cannulated bone screw and plate system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on device performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set information is not present in the provided 510(k) summary.

Instead, the document states:

• Acceptance Criteria/Performance: Not explicitly defined or measured with a study detailed in the way requested. The core of the submission is demonstrating "geometric equivalence and engineering rationale" and "substantial equivalence" to predicate devices.
• Study Data Summary: "Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence." This refers to comparative analysis of design, materials, and intended use against existing, approved devices, not a clinical performance study with defined acceptance criteria and statistical outcomes.

In summary, the provided document does not contain the information required to populate the requested table and answer the specific study-related questions. It's a regulatory submission demonstrating equivalence, not a clinical trial report.

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The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.

K121672 is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding AI/ML device performance, such as sample size for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information relevant to this device's acceptance criteria and studies:

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 is a hardware device (bone plate), and the "test set" refers to mechanical testing of the device itself, not patient data in the context of an AI/ML study. The 510(k) summary does not specify the number of devices tested, but the standard ASTM F382-99 would dictate the number of samples required for static and dynamic testing. Data provenance for such mechanical testing typically pertains to the testing laboratory and its adherence to standards, not patient data.

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 the context of expert review for medical imaging or clinical outcome is not relevant for this type of mechanical device submission. The "ground truth" for mechanical testing is established by the ASTM F382-99 standard and the physical properties observed in controlled laboratory conditions.

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

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions on ground truth, which is not relevant for mechanical testing of a hardware device.

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 device is a bone plate, so it does not involve human readers, AI, or MRMC studies.

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

• Not Applicable. This device is a bone plate and does not involve any algorithms or AI.

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

• Mechanical Performance Standards. For this device, the "ground truth" is defined by the established industry standards for mechanical testing of bone plates (ASTM F382-99). The device's performance is compared against the known safe and effective performance of the predicate devices according to these standards.

8. The sample size for the training set

• Not Applicable. This device is a bone plate and does not involve AI or training sets.

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

• Not Applicable. This device is a bone plate and does not involve AI or training sets.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" conducted for the AFT™ Proximal Humerus Fracture Plate to demonstrate it meets acceptance criteria and is substantially equivalent was primarily a mechanical performance study coupled with a comparison to predicate devices for materials and design.

• Study Type: Mechanical Testing and Substantial Equivalence Comparison.

• Methodology:

  • Mechanical Testing: The device underwent static and dynamic bending testing according to the ASTM F382-99 standard. This standard prescribes methods for quantitatively determining the bending stiffness and strength of metallic bone plates. The 510(k) summary explicitly states this testing was performed "to demonstrate substantial equivalence." This implies that the device's performance in these tests was found to be comparable to or better than the predicate devices, thereby meeting the necessary mechanical acceptance criteria for safety and effectiveness.
  • Predicate Device Comparison: The submission also relies heavily on direct comparison to legally marketed predicate devices (Synthes LCP Proximal Humerus Plate, Synthes 4.5mm Non-Locking Cannulated Screw, Zimmer NCB Proximal Humerus Non-Locking Screw). The manufacturer asserts that the AFT™ Proximal Humerus Fracture Plate has the "same 'Indications for Use'," uses similar materials (Ti-6Al-4V, a common and accepted material for such implants), and has a comparable design (low-profile, anatomically shaped, accepts standard screws).

• Conclusion: Based on the mechanical testing (meeting ASTM F382-99 standards) and the comparison of indications, materials, and design to the predicate devices, the FDA concluded that the AFT™ Proximal Humerus Fracture Plate is "substantially equivalent" to the predicate devices. This determination signifies that the device meets the necessary safety and effectiveness criteria for market clearance.

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The Cuff Repair Plate™ is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

The Cuff Repair Plate (CRP) is a fixable suture anchor plate that is designed to improve anchorage-to-bone strength during rotator cuff tendon-to-bone repair. When assembled, the device consists of a contoured, D-shaped buttress bone plate that is coupled to two anchor bolts. The plate is available in both right and left configurations. Anchor bolts are available in various lengths. Both the plate and the anchor bolts are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use. The CRP is for use with #2 or #5 polyethylene-based high-strength non-absorbable braided suture.

The provided text describes a medical device, the Cuff Repair Plate (CRP), and its regulatory clearance through a 510(k) submission. However, it does not contain information about acceptance criteria, efficacy studies, or performance compared to specific metrics. The document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness based on mechanical testing.

Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets (e.g., minimum pull-out strength, maximum bending). The document implies that the acceptance criterion is "substantial equivalence" to the predicate device in terms of performance.
• Reported Device Performance: The document states that "Testing of the CRP device to demonstrate substantial equivalence included construct pull-out testing, CRP static three-point bending, and testing to evaluate the anchor bolt's torsional strength, insertion driving torque, and axial pull-out." However, no specific numerical results or comparison data from these tests are provided. Therefore, a table cannot be populated as requested.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned. It's safe to assume the mechanical testing was conducted in a laboratory setting, likely in the US, but this is not explicitly stated. The study is a pre-clinical mechanical study, not a clinical study involving human data.

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

• Not Applicable. This information is relevant for studies involving subjective assessment (e.g., image interpretation by radiologists). The described studies are mechanical performance tests, where "ground truth" is determined by objective measurements of force, torque, and displacement.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication is relevant for subjective assessments where multiple experts might disagree. Mechanical tests are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is a type of clinical study. The provided document describes pre-clinical mechanical testing, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Mechanical Test Results (Objective Measures): The "ground truth" for the tests mentioned (pull-out testing, three-point bending, torsional strength, insertion driving torque, axial pull-out) would be the objective measurements obtained from these physical tests. There is no subjective ground truth like expert consensus, pathology, or outcomes data mentioned in relation to these tests.

8. Sample Size for the Training Set:

• Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As explained above, this device does not involve an AI algorithm with a training set.

Summary based on the provided text:

The 510(k) submission for the Cuff Repair Plate (CRP) relied on pre-clinical mechanical testing to demonstrate substantial equivalence to a predicate device (Synthes Button Plate). The tests included construct pull-out, static three-point bending, anchor bolt torsional strength, insertion driving torque, and axial pull-out. The document asserts that these tests showed the CRP to be safe and effective and substantially equivalent to the predicate device, implying that the performance met unstated acceptance criteria by being comparable to the predicate. No specific quantitative acceptance criteria or detailed numerical performance data from these tests are provided. The study did not involve human readers, clinical cases, or AI algorithms; therefore, many of the requested points are not applicable.

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