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The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bystem and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™HiMAX™ Implant System cleared in K142727, K181410 and K193452.

The subject devices branded as DynaBunion and DynaMet are additional plate confiqurations and screws being added to the predicate system, MotoBAND CP Implant System.

DynaBunion™ 4D Minimal-incision Bunion System:
The subject DynaBunion™ 4D Minimal-incision Bunion System includes the addition of the DynaBunion plates and screws to the MotoBAND CP Implant System. The Anti-Drift Bolt (ADB) is a modification of the MotoBAND CP Implant System screws for optional use with the subject DynaBunion plate to anchor the first metatarsal back to the base of the second metatarsal. DynaBunion instruments are used with the MotoBAND CP Implant System for the Lapidus procedure. The cut block and all associated instruments are Class I exempt instruments and may be used with previous versions of the MotoBAND CP Lapidus plates.

DynaMet™ Lesser TMT Fusion System:
The subject DynaMet™ Lesser TMT Fusion System includes the addition of the DvnaMet staple compression plates (SCP) to the MotoBAND CP Implant System. The subject plates have 8 configurations with templates and are compatible with 15mm or 18mm HiMAX C staples. The subject plates are compatible with the same MotoBAND CP screws cleared in K193452. The DynaMET plates are a variation of plate designs for a specific application.

The provided document is a 510(k) summary for the MotoBAND™ CP Implant System, which includes the DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System. This submission focuses on demonstrating substantial equivalence to predicate devices for these metallic bone fixation appliances.

It's important to note that this document does not describe a study involving device performance evaluated against acceptance criteria using patient data, AI, or human readers. Instead, it describes an engineering analysis to demonstrate substantial equivalence based on mechanical properties and design.

Therefore, I cannot provide information for many of the requested categories (e.g., sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) as they are not relevant to the type of submission described.

Here's an analysis based on the information provided, focusing on what is present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical or patient data test set was used. The evaluation was based on engineering analysis and comparison to predicate devices, focusing on mechanical properties and design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth based on expert review of clinical data was established. The "ground truth" here is the established mechanical performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication of clinical data was performed.

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

Not applicable. This is not an AI-enabled device, and no MRMC study was conducted.

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

Not applicable. This is a medical implant, not an algorithm, and no standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the established mechanical and material properties and performance of the legally marketed predicate devices. The subject device demonstrates substantial equivalence by showing that its engineering characteristics (strength, materials, design, intended use) are equivalent to or exceed those of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used. This is an engineering comparison, not a machine learning model.

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

Not applicable. No training set was used. The "ground truth" for comparison (predicate device performance) was established through prior regulatory clearances and mechanical testing of those predicate devices.

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