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

The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA regarding "The Radian MIS Bunion System". This document focuses on the regulatory clearance of a medical device (a bone fixation system) based on its substantial equivalence to previously cleared predicate devices.

The document does not describe any acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance.

Instead, it details the physical and mechanical performance testing of the Radian MIS Bunion System hardware (plate and screws), which are orthopedic implants, to demonstrate their safety and efficacy for their intended use.

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study, as no such study is mentioned or relevant to this specific FDA clearance.

Here's a breakdown of what is available regarding the device (not an AI algorithm):

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

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

• Sample Size: Not specified for the mechanical tests, but these would typically involve a set number of physical devices/components for destructive and non-destructive testing.
• Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based mechanical tests.

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. "Ground truth" in this context refers to the physical properties and performance of medical hardware, not interpretation of data by human experts for diagnostic purposes. These properties are established by standardized testing methods (e.g., ASTM F382) and engineering principles.

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

• Not applicable. Adjudication methods are used for resolving disagreements in expert interpretations or labels, which is not relevant to mechanical testing of hardware.

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:

• No, not specified and not applicable. This type of study is for evaluating diagnostic performance, typically of AI tools, and is not mentioned for this orthopedic device.

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

• No, not applicable. This document is about a physical medical device, not an algorithm.

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

• Not applicable in the AI/ML sense. For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and constructs under tested conditions as measured by calibrated equipment and compared against established engineering standards (e.g., ASTM F382) and the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm discussed that would require a training set.

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

• Not applicable. There is no AI/ML algorithm discussed.

Summary of the Study Discussed (Mechanical Testing):

The "study" described in the 510(k) summary is a set of non-clinical mechanical tests performed on the Radian MIS Bunion System.

• Tests performed:
  • Static bending (per ASTM F382)
  • Dynamic bending (per ASTM F382)
  • Engineering analysis to evaluate screw mechanical strength
• Purpose: To demonstrate that the Radian MIS Bunion System is "substantially equivalent" to predicate devices in terms of safety and efficacy, particularly regarding its mechanical performance.
• Conclusion: The tests indicate that the device does not raise new issues of safety or efficacy and is substantially equivalent to the predicate devices.

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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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