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The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies the surface electromyography (sEMG) signal to realize the control of the upper limb prosthetic device. The collected EMG signals are processed through specific algorithms to achieve the delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.

The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.

The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.

The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.

The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:

• Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
• Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
• Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
• Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
• Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.

In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the hand.

The provided text is a 510(k) summary for the Dexus Prosthetics System. It does not describe a study that uses AI or machine learning, nor does it conduct a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study. The device in question is an electromechanical prosthetic system, and the submission primarily focuses on engineering and component comparability to a predicate device, along with performance against established safety and electrical standards.

Therefore, many of the requested criteria cannot be answered from the provided text, as they pertain to clinical or AI-driven performance testing which was not conducted or reported in this submission.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance:

The document doesn't explicitly define "acceptance criteria" in terms of clinical performance metrics (like accuracy, sensitivity, specificity for an AI model). Instead, acceptance is implied by meeting safety and performance standards for an electromechanical device and demonstrating substantial equivalence to a predicate. The "Reported Device Performance" is primarily from bench testing against these standards rather than clinical outcomes or AI model performance.

Information Not Present in the Document (Related to AI/Clinical Trial Requirements):

The following points cannot be answered from the provided text because it's a 510(k) summary for a physical medical device, not an AI/ML-based diagnostic or therapeutic software, and no clinical studies were performed.

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No clinical test set or ground truth establishment process is described.
3. Adjudication method for the test set: Not applicable.
4. 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, it was explicitly stated: "No clinical study is included in this submission." This means no human reader study, with or without AI assistance, was performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is an electromechanical prosthetic arm, not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth or AI model performance is evaluated. The "ground truth" for this submission revolved around engineering specifications and compliance with recognized standards.
7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document IS:

The document is a US FDA 510(k) premarket notification summary. It aims to demonstrate "substantial equivalence" of the Dexus Prosthetics System to a legally marketed predicate device (Otto Bock Healthcare Products GmbH's Axon-Bus Prosthetic System). The safety and effectiveness are established primarily through bench testing against recognized international standards (IEC, ISO) and by comparing the technical characteristics and intended use to the predicate device, highlighting that any differences do not raise new questions of safety or effectiveness. No clinical studies were conducted, nor does the device appear to incorporate AI/ML as its primary function for which performance would be evaluated as such.

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