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The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The CHARLOTTE™ LisFranc Bone Screw is offered in 2 diameters and a range of lengths to accommodate variability among patients. All screws are made from stainless steel.

The CHARLOTTE™ LisFranc Plate consists of plates, non-locking screws, and locking screws. All components are manufactured from stainless steel.

The provided text is a 510(k) summary for a medical device (bone screw and plate) and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-based diagnostic devices.

The document focuses on establishing substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria through a clinical or analytical study.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The safety and effectiveness of the CHARLOTTE™ LisFranc Bone Screw and CHARLOTTE™ LisFranc Plate are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification." (Page 1, Section C)

This implies that the submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data from human or AI-based evaluations.

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The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).

The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

This 510(k) summary describes a medical device, the Lisfranc Plate, and its mechanical testing for substantial equivalence to a predicate device. It is not a study of an AI/ML device, and therefore the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for an AI/ML device's diagnostic performance. Instead, the acceptance criterion for this medical device (Lisfranc Plate) is based on demonstrating substantial equivalence in mechanical properties to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not provide details on the number of samples tested.
• Data Provenance: Not specified, but implied to be from laboratory mechanical testing of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This is a mechanical device test, not a diagnostic or AI/ML evaluation requiring expert-established ground truth on patient data. The "ground truth" here is the physical performance of the device under specific mechanical testing conditions, compared to the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. This is a mechanical device test. The comparison is made against the known performance data of the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI/ML or diagnostic device; it's a fixation plate. Therefore, an MRMC study is not relevant.

6. If a Standalone Performance Study Was Done

• Yes, implicitly. Mechanical tests were performed on the modified Lisfranc Plates in a "standalone" fashion (i.e., the device itself was tested). The performance was then compared to data from the predicate device, K060474.

7. The Type of Ground Truth Used

• Mechanical Test Data: The ground truth for comparison was the established mechanical performance characteristics of the predicate Lisfranc Plates (K060474) and the scientific principles of mechanical engineering.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, no training set for an AI/ML algorithm was involved.

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The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)

The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

Here's an analysis of the provided 510(k) summary regarding the Newdeal Lisfranc Plates, focusing on acceptance criteria and supporting studies:

This 510(k) summary describes a traditional device clearance process for a new medical implant, not an AI/ML-driven diagnostic device. Therefore, many of the requested categories (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not provided in this type of submission. The focus for mechanical devices like bone plates is on performance testing against a predicate device and material specifications.

Here's a breakdown of the available information:

Description of Acceptance Criteria and Study Findings

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets acceptance criteria:

The primary study cited is performance testing conducted compared to a legally marketed predicate device. The key finding is that the Lisfranc Plates demonstrated "comparable results" in all mechanical aspects relevant to the intended use when compared to the predicate device. This implies that the device met the mechanical performance standards set by the predicate.

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

• Not Applicable / Not Provided. For mechanical performance testing of an orthopedic implant, "test set" typically refers to the number of devices or constructs tested in a laboratory setting. This 510(k) summary does not specify the number of samples tested biomechanically. The concept of "data provenance" (country of origin, retrospective/prospective) is not relevant for this type of mechanical testing submission.

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

• Not Applicable / Not Provided. "Ground truth" established by experts is typically for diagnostic imaging or clinical outcome data. For mechanical devices, the "ground truth" is defined by established engineering and biomechanical standards and the performance of predicate devices.

4. Adjudication method for the test set

• Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical cases or diagnostic interpretations, which is not relevant for a mechanical device performance study described here. The "adjudication" for mechanical testing would be the interpretation of engineering data by qualified biomechanical engineers.

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 device is a bone plate, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This device is a physical bone plate, not an algorithm.

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

• For this type of device, the "ground truth" is based on:
  • Biomechanical engineering standards: Established testing protocols for strength, fatigue, pull-out strength, etc., relevant to bone fixation.
  • Predicate device performance: The performance characteristics of the legally marketed predicate device serve as the benchmark for substantial equivalence.
  • Material standards: Compliance with recognized standards for biocompatibility and material properties.

8. The sample size for the training set

• Not Applicable / Not Provided. The concept of "training set" applies to AI/ML models. This is a mechanical device.

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

• Not Applicable / Not Provided. As there is no training set mentioned, this question is not relevant.

In summary: The 510(k) for the Lisfranc Plates relies on the principle of substantial equivalence to existing, legally marketed predicate devices. The "study" proving this equivalence is mechanical performance testing that demonstrates comparable results to the predicate. The detailed methodologies commonly found in AI/ML or clinical trial submissions (like expert panels, detailed sample sizes, adjudication, etc.) are not part of this type of traditional device submission.

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