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The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6Al-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K152306), the subject Ø3.0mm MIS Bunion locking screw, or the optional subject Ø2.7mm non-locking screw in the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, osteotome guide and osteotome, a suture passing loop, drill bit and handle. Additional general surgical instrumentation utilized include reamers, drill guide/depth gauge. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The MIS bunion implant wedges firmly within the intramedullary canal and acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections, the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) or the subject MIS Bunion Ø 3.0mm polyaxial locking screws in the most distal hole, in addition to the optional subject Ø2.7mm non-locking screw accepted only in the angular cross hole for additional fixation of the implant to the metatarsal shaft.

This Special 510(k) submission seeks to modify the design of the previously cleared plate to add an additional angular distal screw hole to accept optional placement of the subject Ø2.7mm non-locking screw for additional plate stability. Additionally, this submission seeks to expand the size range of the plates to include a shorter length plate to better accommodate patient anatomy.

The provided text is a 510(k) summary for the CrossRoads Extremity Systems, LLC MIS Bunion Plating System. This document describes a medical device and its equivalence to a previously cleared device, not an AI or software device that would require specific performance criteria based on an algorithm's accuracy, sensitivity, or specificity.

Therefore, the information required to answer your prompt, which is tailored for performance claims of AI/ML or diagnostic devices (e.g., acceptance criteria for accuracy, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details), is not present in this document.

This 510(k) filing primarily focuses on:

• Device Description: The physical characteristics and materials of the MIS Bunion Plating System.
• Indications for Use: What the device is intended to treat (fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus).
• Substantial Equivalence: How the modified device is similar to a previously cleared predicate device (K181872). The changes are design modifications to the plate (additional screw hole, shorter length plate) and new screw sizes.
• Performance Testing: This refers to mechanical analysis and screw pull-through construct testing to demonstrate that the design changes do not worsen the device's structural performance compared to the predicate device. It explicitly states, "Thus, it was determined that no additional mechanical testing is required."

In summary, this document does not contain the type of data or study design that your questions refer to for evaluating an algorithm's performance on a test set using ground truth established by experts.

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The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6A1-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K 152306 ) in the distal end of the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, and osteotome. Additional general surgical instrumentation utilized include reamers, drill guide, and depth guage. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The effect of the MIS Bunion implant being wedged firmly within the intramedullary canal is that it acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections. the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) to secure the metatarsal head firmly in place, allowing fusion to occur.

The provided text does not describe an AI/ML device or a study involving such a device. Instead, it describes a medical device called the "MIS Bunion System" which is a metallic bone fixation appliance. The document is an FDA 510(k) premarket notification, which focuses on device design, materials, and substantial equivalence to predicate devices, rather than algorithmic performance.

Therefore, many of the requested categories related to AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training set, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant "acceptance criteria" (performance testing) and the study that proves the device meets them, based on the information provided for this specific type of medical device:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Mechanical Testing: The document does not specify a numerical "sample size" for the theoretical analysis or pull-out testing beyond implying that worst-case cross-sections were analyzed and pull-out tests were conducted. It doesn't mention data provenance in terms of country of origin or retrospective/prospective; these tests are typically internal laboratory tests.
• Pyrogen Testing: The document does not specify the number of samples or batches tested for pyrogenicity. Data provenance is not mentioned.

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

• This question is not applicable as the studies are mechanical and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the clinical sense.

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

• Not applicable for mechanical and biocompatibility testing. The "adjudication" is based on meeting defined engineering and safety limits.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• For mechanical testing, the "ground truth" is defined by established engineering principles, material properties (e.g., ASTM F136 for Ti-6A1-4V ELI), and performance metrics (e.g., pull-out force), often in comparison to a predicate device.
• For pyrogen testing, the "ground truth" is the established endotoxin limit (20 Endotoxin Units (EU)/Device).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for this type of mechanical device.

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

• Not applicable as this is not an AI/ML device.

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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:

1. A table of acceptance criteria and reported device performance related to AI/software metrics (e.g., sensitivity, specificity, accuracy).
2. Sample sizes for test sets (as there's no diagnostic test set).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC studies or effect sizes for human readers.
6. Standalone algorithm performance.
7. Types of ground truth (as it relates to diagnostic accuracy).
8. 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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