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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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The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

3. Number of experts used to establish the ground truth... and qualifications of those experts:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device APTUS Coronoid 2.0 plates have an anatomical design and are provided for the left and right ulna. The plates have a uniform thickness of 1.6 mm. The subject device plates are compatible with 2.0 mm diameter screws, and are used with TriLock locking screws and cortical (nonlocking) screws. The compatible screws have cortical threads, are presently marketed as part of the APTUS System, and were cleared under K051567 and K090053. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

The provided text describes the 510(k) premarket notification for the Medartis AG APTUS® Coronoid 2.0 device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of a clinical trial or AI device validation.

Instead, the "acceptance criteria" here are focused on demonstrating mechanical performance of the device itself (a bone plate and screw system) and showing it is equivalent to or better than predicate devices. The "study" is a series of non-clinical mechanical tests.

Here's a breakdown of the requested information 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 specify exact sample sizes (e.g., number of plates or constructs) used for the mechanical tests. It refers to these as non-clinical testing data.

• Sample Size (Test Set): Not specified in the provided text. The tests involve "subject device constructs" and "predicate device constructs," suggesting multiple samples were tested for each.
• Data Provenance: Non-clinical testing results. No geographical location or retrospective/prospective nature is mentioned for these lab tests, which is typical for mechanical performance data.

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

Not applicable. This is a non-clinical mechanical performance study for a physical implant, not a study evaluating human interpretation or an AI algorithm that requires expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical mechanical performance study.

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

No. This is a non-clinical mechanical performance study for a physical implant. It does not involve human readers or AI.

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

No. This is a non-clinical mechanical performance study for a physical implant. It does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is established by the specified mechanical testing standards (ASTM F382) and a simulated coronoid fracture model. The performance is objectively measured against these predefined physical and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical mechanical performance study for a physical implant. There is no concept of a "training set" as there is no algorithm being trained.

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

Not applicable, as there is no training set mentioned or implied.

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