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The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable™ Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.

The SuperCable" Grip and Plate System consists of trochanteric reattachment grips, cable-plates, and cortical bone screws that are intended to be used in conjunction with 1.5mm diameter SuperCable Iso-Elastic Cerclage polymer cables. The cables pass through the grips and plates and provide fixation by attaching these devices to fractured or osteotomized bone fragments. Cortical bone screws may be used in combination with the cable-plates for additional fixation as deemed necessary by the surgeon user. The system includes a range of cable grip, cable-plate, and bone screw sizes and material options, with associated manual surgical instrumentation.

Trochanteric reattachment grips are available in a minimum of four lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the grip on the anterior or posterior surface of the proximal femur. The cable hole exit geometry is designed for optimal cable trajectory and cable contact stress when the grip is affixed to the greater trochanter. Each grip contains two proximal claws that hook into or over the proximal portion of the trochanter fragment and prevent the grip from migrating distally. Each grip also contains two smaller distal claws that penetrate the trochanter fragment distally for additional fixation and stability. The longer grips incorporate an extension to allow for transversely oriented cables around the diaphysis below the lesser trochanter to better resist trochanteric migration or rotation. These longer extensions contain slots for the insertion of compression or locked cortical bone screws into the bone. The grips are available in titanium alloy, cobalt-chromium allov, or stainless steel allov.

Cable-plates are available in a minimum of three lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse plate holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the plate. The plates also contain alternating slots for the insertion of compression or locked cortical bone screws into the bone. By combining locking screw holes with compression slots. the plates can be used as both locking devices and fracture compression devices. The plates resemble standard plates, but have figure-of-eight shaped slots that accommodate standard or locking screws. Thus the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as a system combining both techniques. The cable hole exit geometry is designed for optimal contact stress within the cable when the plate is affixed to a long bone. The cable-plates are available in titanium alloy, cobalt-chromium alloy, or stainless steel alloy.

Bone screws are standard self-tapping cortical bone screws and are available in multiple lengths. The screws heads are available in standard compression or locked designs. The bone screws are available in titanium alloy or stainless steel. The product labeling specifies the screw and plate/grip material combinations which may be used together.

Manual instrumentation includes a grip inserter/impactor, drill, depth gage, screwdriver, and sterilization case. All implants are supplied in a non-sterile condition.

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving adherence, as requested:

Acceptance Criteria and Device Performance for K072250

Based on the provided document, the device in question is the SuperCable™ Grip and Plate System. This is a premarket notification (510(k)) submission for a medical device, and as such, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices rather than specific quantitative performance metrics like sensitivity or specificity that would be typical for an AI/diagnostic device.

The study employed to demonstrate this "acceptance" (i.e., substantial equivalence) is a performance analysis that relied on mechanical and finite element analyses.

Here's the breakdown of your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the models and physical specimens used for mechanical and finite element analyses. The document does not specify the number of simulations or physical parts tested.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from engineering analyses (mechanical testing and finite element modeling). This is not retrospective or prospective patient data from a specific country. This type of data provenance is typical for non-clinical performance studies of orthopedic implants.

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

• Number of Experts: Not applicable. Ground truth for mechanical and finite element analyses is typically established by engineering principles, material science, and established biomechanical testing standards, not by clinical expert consensus in the way an AI diagnostic algorithm's ground truth would be.
• Qualifications of Experts: While not explicitly stated as "experts for ground truth," the performance analysis would have been conducted or overseen by engineers and potentially biomechanical specialists familiar with mechanical testing and finite element analysis. Their qualifications would stem from their expertise in these engineering disciplines.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretative "test set" requiring adjudication. The outcomes of mechanical tests and finite element analyses are based on physical measurements and computational models, not subjective human judgment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not performed, nor would it be appropriate for this type of device (an orthopedic implant). MRMC studies are typically used for evaluating diagnostic imaging or AI systems where human readers interpret medical images.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable. This device is an orthopedic implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to measure. Its performance is inherent in its physical and mechanical properties.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance analysis was derived from:
  • Engineering principles and material properties: For Finite Element Analysis (FEA).
  • Physical measurements and established biomechanical test methods: For mechanical testing.
  • Comparison to predicate device performance benchmarks: To demonstrate "greater strength" or at least comparable performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." The design is based on engineering principles, materials science, and established medical needs, not data-driven algorithmic training.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of mechanical device.

In summary, the provided document details a 510(k) submission for an orthopedic implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing predicate devices in terms of materials, design, sizing, indications, and safety. The "study" proving this substantial equivalence was a performance analysis based on mechanical testing and finite element analysis, showing comparable or superior strength without introducing new risks. This is a standard non-clinical pathway for FDA clearance of Class II orthopedic devices.

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