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510(k) Data Aggregation
(149 days)
MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion
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
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength | "The strength of the plates exceeds the strength of the worst-case implants in the predicate system." |
| Material Compatibility | "Subject and predicate devices are manufactured from titanium alloy (ASTM F136)." (Implies material compatibility and known performance). |
| Basic Design | "The MotoBAND™ CP Implant System possesses the same technological characteristics as the predicate devices, including... Basic design." |
| Intended Use | "There are no substantive differences between the subject and predicate with respect to intended use..." Indications for use are consistent with predicate. |
| Technological Characteristics | "There are no substantive differences between the subject and predicate with respect to... technological characteristics." |
| New Worst-Case (Dimensional) | "Engineering analysis demonstrated that the dimensional differences do not create a new worst-case for the system. The dimensions are within previously plates of the MotoBAND family." |
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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(28 days)
MotoBAND CP Implant System
The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.
The subject MotoBAND CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries are 5° valgus and have options of 0°,5°, and 10° dorsiflexion and can be used with 18mm, 20mm or 25mm nitinol clip. Non-locking and poly-axial locking screws are included in the system: 3.0mm diameter and 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP Implant System is compatible with MotoCLIP/HiMAX Clips.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification letter from the FDA to CrossRoads Extremity Systems, LLC regarding the MotoBAND CP Implant System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against defined acceptance criteria through a specific study.
The key points from the document regarding the device are:
- Device Name: MotoBAND™ CP Implant System
- Intended Use: Stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
- Comparison to Predicate: The submission compares the MotoBAND CP Implant System to a primary predicate (K173710 MotoBAND CP Implant System) and an additional predicate (K181410 MotoCLIP™/HiMAX™ Implant System).
- Changes from Predicate: The subject device includes:
- Longer bridge length clips (20mm and 25mm)
- Longer length screws (32-50mm)
- Plate geometry modification for clip compatibility (maximum plate length decreased, thickness and width similar).
- Performance Testing (Engineering Analysis): An engineering analysis of the "worst case" MotoBAND™ CP Implant System with MotoCLIP™/HIMAX™ Implant System was performed.
- Results: This analysis showed that the strength of the plates, staple bending strength and bending stiffness, and staple/screw fixation performance exceeds the strength of the worst-case implants in the predicate system.
- Conclusion from Analysis: "No additional mechanical testing is required. The results demonstrate the performance of the subject MotoBAND CP Implant System is substantially equivalent to the predicate device."
Therefore, based on the provided text, the specific information requested in the prompt (acceptance criteria, details of a study proving compliance, sample sizes, ground truth establishment, MRMC studies, etc.) is not present. The FDA clearance is based on a demonstration of substantial equivalence through engineering analysis comparing the new device to a predicate, not on a clinical or performance study with defined acceptance criteria for standalone performance.
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(70 days)
MotoBAND CP Implant System
The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.
The MotoBAND™ CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include valgus options of 0°, 5° and 10°, dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options to use either a 15mm or 18mm nitinol clip. MotoBAND™ CP Implant System is compatible with MotoCLIP™ Staple.
The provided FDA K173710 document for the MotoBAND™ CP Implant System does not contain the information requested regarding acceptance criteria and study details for a medical device that relies on AI or software for its performance evaluation (e.g., image analysis, diagnostic support devices).
The MotoBAND™ CP Implant System is a physical medical device (metallic bone fixation fastener, plate system) used for orthopedic fixation. Its substantial equivalence determination is based on:
- Theoretical analysis: Predicting torsional, pullout, and plate bending strengths.
- Comparison to predicate devices: Showing that the subject device's predicted performance is substantially equivalent to previously cleared devices (K152306, K160300).
- Materials: Stating the material used (titanium alloy).
- Indications for Use: Matching the scope of the predicate devices.
Therefore, the document does not include:
- A table of acceptance criteria and reported device performance related to AI/software metrics (e.g., sensitivity, specificity, accuracy).
- Sample sizes for test sets (as there's no diagnostic test set).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC studies or effect sizes for human readers.
- Standalone algorithm performance.
- Types of ground truth (as it relates to diagnostic accuracy).
- Training set sample sizes or ground truth establishment for training data.
The performance testing mentioned in the document refers to mechanical integrity and strength tests for the physical implant, not data-driven performance of a diagnostic or AI-enabled device.
In summary, this document is irrelevant to the prompt's request for information about a study that proves a device meets acceptance criteria related to AI or data-driven performance.
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(119 days)
MotoBand¿ CP Implant System
The MotoBand™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.
The MotoBAND™ CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include the double Y plate, Y-plate, straight plate (2 hole, 4 hole and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion.
This document describes the MotoBAND™ CP Implant System, a medical device for orthopedic fixation. It does not contain information about an AI/machine learning device or a corresponding study with acceptance criteria for such a device. The content focuses on the substantial equivalence of the implant system to predicate devices based on theoretical performance analysis.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/machine learning device as the provided document pertains to a traditional medical implant, not an AI system.
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