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510(k) Data Aggregation
(149 days)
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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(78 days)
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™ CP Implant System with the execption of the MTP plates and 2-hole plate may be used with the MotoCLIP™ Implant System
The MotoBANDTM CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. MotoBANDTM CP Implant System is compatible with MotoCLIPTM Implant System. The MotoBANDTM implants are manufactured from titanium alloy (ASTM F136). Each hole in the plate accepts locking or non-locking screws. Certain plates have a slot that accepts the MotoCLIPTM nitinol staple. MotoBANDTM CP Implant System is compatible with the MotoCLIPTM Implant System The MotoCLIPTM implants are made of biocompatible nitinol and are designed to exhibit superelastic properties.
MotoBAND™ CP Implant System
This document describes the acceptance criteria and study proving the MotoBAND™ CP Implant System meets these criteria. The device is intended for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the biocompatibility and mechanical integrity of the device, particularly when the MotoBAND™ CP system is used in conjunction with the MotoCLIP™ nitinol compression staple. The acceptance criteria are implicitly tied to the absence of adverse galvanic corrosion and a maintained passive state of the nitinol component, along with mechanical stability under fatigue.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Galvanic Corrosion | Nitinol component should remain in a passive condition and exhibit a breakdown potential sufficiently above the galvanic mixed potential, indicating no pit initiation due to galvanic interactions. Breakdown potentials pre- and post-fatigue should remain unchanged. | "The nitinol remains in a passive condition and exhibits a breakdown potential sufficiently above the galvanic mixed potential. Pit initiation due to galvanic interactions should not occur." |
| "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." | ||
| "A comparison of the breakdown potentials of the pre and post-fatigue samples indicates no significant difference in the samples." | ||
| Mechanical Fatigue | The combined construct (plate and staple) should function without failure that would indicate a risk for clinical use, particularly demonstrating that the fatigue test of the MotoBAND™ titanium plates does not impart a failure mode to the MotoCLIP™ compression staple. Breakdown potentials pre- and post-fatigue should remain unchanged. | "Testing indicates that fatigue test of the MotoBAND™ titanium plates used with a MotoCLIP™ compression staple does not impart a failure mode to the staple that would indicate a risk for clinical use." |
| "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." | ||
| Wear and Corrosion | Minimal wear and corrosion between the plate and staple constructs under cyclic loading. | "Pre and post fatigue analyses were conducted on the plate and staple constructs to evaluate the wear and corrosion between the two devices." (The successful outcome reported in the other categories implies acceptable wear and corrosion performance.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set. The data provenance is described as performance testing conducted by the manufacturer, CrossRoads Extremity Systems, as part of their 510(k) submission. This is retrospective testing performed on manufactured devices. The country of origin of the data is implicitly the USA, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves mechanical and electrochemical performance testing of a medical device's physical properties, not a diagnostic or AI-driven system requiring expert assessment of ground truth in medical images or conditions. The "ground truth" here is objective scientific measurement (e.g., breakdown potential, mechanical failure).
4. Adjudication method for the test set
Not applicable. As described in point 3, this is objective performance testing, not a study requiring adjudication of expert opinions.
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 a performance study for a surgical implant system, not a diagnostic device or an AI assistant for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for this performance testing is established through objective scientific measurements and analyses in a laboratory setting. This includes:
- Electrochemical measurements for cyclic polarization and galvanic corrosion susceptibility.
- Mechanical testing for fatigue and structural integrity.
- Material science principles (e.g., passive condition of nitinol, breakdown potential).
8. The sample size for the training set
Not applicable. This is a performance study for a physical device, not a machine learning model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As described in point 8, there is no training set for this type of performance study.
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