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APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

The subject device includes a total of seven (7) plates are to be applied using a dorsal surgical approach, and have an anatomical design appropriate for either the left or right wrist; two (2) plates are to be applied using a volar surgical approach, and are provided in versions designed specifically for the left and right wrist. The dorsal plates have overall lengths ranging from approximately 61 mm to 116 mm, and maximum widths of 13.5 mm. The volar plates have overall lengths ranging from approximately 39 mm to 42 mm, and overall widths ranging from approximately 16 mm to 26 mm. The plates from the subject device, the primary predicate device, and the reference devices have the same technological characteristics, and have similar design characteristics, include designs for dorsal or volar surgical placement, and include screw holes to accommodate locking and nonlocking screws. The plates from the subject device, the primary predicate device, and the reference devices encompass a similar range of physical dimensions (overall width, overall length, and thickness). The subject device and the primary predicate device K112169 both include plates with similar anatomic designs for dorsal surgical placement. Similarly, the subject device and the reference device K142906 both include plates with similar anatomic designs for volar surgical placement. The plates from the subject device, K112169, K142906, and K051567 are manufactured from identical unalloyed titanium material conforming to ASTM F67. The plates from the subject device, K112169, and K 142906 are compatible exclusively with previously cleared Medartis APTUS® screws, and also are compatible with previously cleared Medartis APTUS® K-Wires. All subject device final, finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared Medartis device components (K112169, K142906, and K051567) and, therefore, are substantially equivalent to these devices regarding biocompatibility. The subject device components and the Medartis device components cleared in K112169 and K142906 are packaged using the same materials, and are to be sterilized by the same methods.

The provided document is a 510(k) summary for a medical device (APTUS® Wrist Arthrodesis Plates), asserting its substantial equivalence to previously marketed predicate devices. This type of regulatory submission does not involve clinical studies to prove acceptance criteria in the way an AI/ML medical device would. Instead, it relies on non-clinical testing (e.g., mechanical, biocompatibility) and a comparison of technological characteristics to already cleared devices.

Therefore, most of the requested information regarding acceptance criteria and performance proven by a study (especially sample sizes, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training data details) is not applicable to this type of device submission.

However, I can extract the relevant information regarding the non-clinical testing and "acceptance criteria" (which in this context refers to demonstrating comparable performance to predicates), and present it in a modified format.

Based on the provided 510(k) summary for the APTUS® Wrist Arthrodesis Plates, the following information can be extracted regarding its "acceptance criteria" and "study" (non-clinical testing) that proves the device meets these criteria:

This submission is a 510(k) premarket notification for a bone fixation appliance, and as such, the "acceptance criteria" and "study" differ significantly from those for an AI/ML-driven medical device. The primary goal is to demonstrate substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics, rather than proving a specific diagnostic accuracy or clinical outcome through a traditional clinical trial.

1. Table of Acceptance Criteria and the Reported Device Performance

For this mechanical device, "acceptance criteria" are implicitly met if the device's performance is comparable or superior to its predicates in specified non-clinical tests, and its technological characteristics and intended use are substantially equivalent.

Results: "Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the reference devices K142906 and K051567." No specific quantitative performance metrics (e.g., force limits, cycles to failure) are provided in this summary, but the conclusion of substantial equivalence implies acceptable performance relative to the predicates. |
| Design Characteristics: Similar anatomical fit and functional features. | The device has similar design characteristics to predicates, including designs for dorsal or volar surgical placement, and screw holes to accommodate locking and non-locking screws. Minor differences in specific dimensions or screw hole placement for new plates were assessed not to impact safety or effectiveness. |
| Material Composition: Compatible and safe materials. | Plates are manufactured from identical unalloyed titanium material conforming to ASTM F67, as used in predicate devices K112169, K142906, and K051567. Screws are made of previously cleared Ti-6Al-4V alloy, ASTM F136. |
| Sterilization: User-level sterilization methods are effective and safe. | Packaged using the same materials and sterilized by the same methods as clear Medartis device components (K112169 and K142906). Provided non-sterile, with the end-user instructed to sterilize by moist heat. |
| Intended Use: Device performs its stated function. | The subject device and the primary predicate device (K112169) share identical Indications for Use: "APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis." Though other reference devices have broader indications (e.g., fractures, osteotomies), the core "internal fixation of the upper extremity" is shared across all, and these minor differences were deemed not to impact substantial equivalence. |

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

• Sample Size: Not specified in terms of human subjects or clinical data for performance evaluation. For mechanical testing, the "sample size" would refer to the number of physical device units tested according to ASTM standards. This information is typically detailed in the full test report, not usually in the 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for acceptance criteria. The data comes from non-clinical bench testing of the physical device and a comparison of engineering specifications and materials to predicate devices. No human subject data (retrospective or prospective) is mentioned for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. As this is a mechanical device submission, there is no "ground truth" in the clinical sense established by human experts for a test set. Substantial equivalence is based on engineering principles, material science, and a comparison to already cleared devices.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the context of human interpretation or clinical data for this type of device submission.

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

• Not Applicable. MRMC studies are typically performed for diagnostic imaging devices where human reader performance is being evaluated, particularly with AI assistance. This device is a passive implantable fixation plate.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a mechanical implant, not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is established through recognized industry standards (e.g., ASTM F382) for mechanical testing and material specifications (e.g., ASTM F67, ASTM F136). The performance is compared to that of legally marketed predicate devices, implying that their demonstrated safety and effectiveness serve as benchmarks for the subject device.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. See point 8.

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OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.

Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.

Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.

The document states:

• "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
• "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.

Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.

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