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EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.

Plates and screws are intended for single use only. Screws are not intended for use in the spine.

The EDGE Orthopaedics' REDUCE® Fracture Plating System Line Extension has been designed to support multiple indications within the forefoot and mid-foot. The line extension includes titanium alloy, sterile packaged H and Box Plates along with sterile titanium alloy bone screws.

The REDUCE Fracture Plating System is offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.

The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.

The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device.

This document, K142135, is a 510(k) Premarket Notification for a line extension to the REDUCE® Fracture Plating System by EDGE Orthopaedics. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140876). As such, it does not detail a study proving the device meets specific performance acceptance criteria in the way a new, innovative device might. Instead, it relies on demonstrating that the new elements (H-plate and Box plate) are technologically equivalent and do not introduce new worst-case scenarios compared to the predicate.

Given this context, the request for acceptance criteria and a study that proves the device meets those criteria needs to be interpreted in terms of the information available in this 510(k) submission.

Here's a breakdown based on the provided text, acknowledging that some requested information (like specific test set sizes for clinical data, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training) are not typically part of a 510(k) for a line extension based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) line extension typically revolve around demonstrating that the new components perform at least as well as, or are equivalent to, the predicate device in terms of safety and effectiveness, leveraging existing data and analyses. Specific numerical performance metrics (like sensitivity, specificity, accuracy) are not reported in this type of submission for this kind of device.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used for a prospective study evaluating the new plates.
• Data Provenance: The reliance is on "CAD and mathematical analysis" (Page 4) to demonstrate that the line extension (H-plate and Box plate) did not create a new worst-case scenario compared to the predicate device. This is a form of in-silico or engineering analysis rather than human-generated clinical data. Since no new clinical data were generated for this line extension, no specific country of origin or retrospective/prospective classification applies to a "test set."

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

• This information is not provided in the document. As clinical data was not used to determine substantial equivalence (Page 4), there was no "test set" requiring expert-established ground truth in the clinical sense. The ground truth for the CAD and mathematical analysis would be based on established engineering principles and material science, likely performed by engineers, but the specific number or qualifications are not disclosed.

4. Adjudication Method for the Test Set

• Not applicable. Since no clinical test set requiring expert interpretation was used, no adjudication method (e.g., 2+1, 3+1) is mentioned or implied.

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

• No. An MRMC study was not performed. The 510(k) explicitly states, "Clinical data was not used to determine substantial equivalence." (Page 4) Therefore, there's no reported effect size of human readers improving with or without AI assistance.

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

• Not applicable. This device is a mechanical implant (fracture plating system), not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is implicitly based on engineering principles, material science, and prior regulatory clearance of the predicate device. The CAD and mathematical analysis would be evaluated against established biomechanical performance standards and material properties, rather than expert consensus, pathology, or outcomes data specifically generated for this line extension. The previous clearance of the predicate device (K140876) serves as the primary benchmark.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve a machine learning algorithm; therefore, there is no "training set" in that context. The "training" for the device's design and manufacturing would implicitly be based on historical data and experience with similar devices, including the predicate.

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

• Not applicable. As there is no "training set" in the sense of a machine learning algorithm, there is no method for establishing its ground truth. The design and manufacturing processes are likely informed by industry standards, biomechanical testing protocols, and feedback from clinical experience with similar devices, all of which contribute to the "ground truth" of safe and effective device design. The "Description of the Device" states "The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device." (Page 3). This implies reliance on the established ground truth for the predicate device's design and manufacturing through its prior clearance.

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EDGE Orthopaedics' VIEW™ and REDUCE™ Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.

Plates and screws are intended for single use only. Screws are not intended for use in the spine.

The EDGE Orthopaedics' VIEW™ Plating System has been designed to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged Lapidus, First Metatarsophalangeal (MTP), Calcaneal-Cuboid (CC), Evans and Talonavicular (TN) Plates along with sterile titanium alloy bone screws. The design creates a "window" offering a continuous view into the healing process.

The EDGE Orthopaedics' REDUCE® Fracture Plating System has been designed to support multiple indications within the forefoot and mid-foot. The system includes titanium alloy, sterile packaged T. L. Y. and Straight Plates along with sterile titanium alloy bone screws.

VIEW and REDUCE Plating Systems are offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.

The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.

The provided document is a 510(k) Premarket Notification for the EDGE Orthopaedics VIEW and REDUCE Plating Systems. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than requiring a comparative effectiveness study with specific acceptance criteria related to a diagnostic algorithm or AI.

Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance, sample size for test sets, ground truth establishment for AI, MRMC studies) is not applicable to this type of device and submission. This device is a bone fixation plate and bone screw, which is a physical orthopedic implant, not a diagnostic or AI-driven system.

However, I can extract the information that is relevant to how the device's safety and effectiveness were demonstrated:

Acceptance Criteria and Device Performance (based on substantial equivalence):

Study Information (Non-Clinical Testing):

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

   • Acceptance Criteria (Implicit): Conformance to specified ASTM standards for mechanical properties, and substantial equivalence to predicate devices in design, materials, and indications for use.
   • Reported Device Performance: The device's safety and effectiveness are "adequately supported by the substantial equivalence information, materials information and the following non-clinical testing":
     • Torsional strength per ASTM F543
     • Driving and removal torque per ASTM F543
     • Axial pull out strength per ASTM F543
     • Single Cycle Bend Testing per ASTM F382

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical, mechanical tests. The "sample size" would refer to the number of devices tested for each mechanical property, which is not specified in the summary document. Data provenance is internal laboratory testing.

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 mechanical testing is based on objective physical measurements and adherence to ASTM standards, not expert clinical consensus.

4. Adjudication method: Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical device, not an AI or diagnostic system.

6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical device.

7. The type of ground truth used: For mechanical testing, the ground truth is the physical properties of the material and design as measured according to standardized methods (ASTM F543, ASTM F382). For demonstrating substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set: Not applicable. There is no training set for a physical device being cleared via substantial equivalence.

9. How the ground truth for the training set was established: Not applicable.

In summary: This 510(k) submission for the EDGE Orthopaedics Plating Systems relies on non-clinical mechanical testing and a demonstration of substantial equivalence to existing predicate devices (DARCO Locking Plating System K061808 and ORTHOLOC® 2.0/2.4 Plate System K090692). Clinical data was explicitly stated as not being used to determine substantial equivalence. The prompt's questions are generally geared towards AI/diagnostic device evaluations, which are not relevant to this orthopedic implant's clearance pathway.

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