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The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies - Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) . - Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) ● - . Talar fractures - Ankle fractures - Navicular fractures - Fractures of the fibula, malleolus, and calcaneus - Metatarsal and phalangeal osteotomies ● - Weil osteotomy - Calcaneal osteotomy ● Hallux Valgus Correction - Fixation of osteotomies (i.e. Akin, Scarf, Chevron) ● - Interphalangeal (IP) arthrodesis . - Proximal, midshaft, or distal osteotomy - Lapidus arthrodesis ● Arthrodesis/Deformity Correction - 1st MTP arthrodesis - Metatarsal deformity correction ● - Tarsometatarsal joint arthrodesis ● - Naviculocuneiform ioint arthrodesis ● - Talonavicular arthrodesis - Subtalar joint arthrodesis - Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - . Ankle arthrodesis - Lateralizing calcaneal osteotomy - Lateral column lengthening - Hammertoe Fusion results from neuropathic osteoarthropathy (Charcot) such as: - Medial and lateral column ● - Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System contains bone screws of various diameters, lengths, and configurations. One configuration is a snap-off style bone screw offered in two diameters having various overall and threaded lengths.

This document describes the regulatory clearance of a medical device, the "Monster Screw System," not an AI/ML powered device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and not present in the provided text.

The document states: "Clinical testing was not necessary to support equivalence." This indicates that no clinical performance study, as would be required for AI/ML device validation, was conducted or submitted for this device's 510(k) clearance.

The clearance is based on substantial equivalence to a predicate device, meaning the new device has the same intended use and technological characteristics as the previously cleared predicate, and does not raise new questions of safety or effectiveness. The non-clinical testing performed focuses on material, manufacturing, and sterilization properties, not a performance evaluation in a clinical setting against a specific diagnostic or clinical outcome acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance, as such a study was not performed for this device's clearance.

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The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.

This document is a 510(k) summary for the Paragon 28 Monster Screw System™. It describes the device and its intended use, but it does not contain the kind of detailed performance study data you're asking for regarding acceptance criteria, sample sizes, ground truth (which is typically for diagnostic devices), or comparative effectiveness studies.

This submission is for a bone fixation fastener, which is a hardware device, not a diagnostic AI/ML device. Therefore, the questions about "acceptance criteria and study that proves the device meets the acceptance criteria" are typically addressed through mechanical testing and equivalence to predicate devices, rather than clinical performance metrics, ground truth established by experts, or AI-specific study designs like MRMC or standalone performance.

However, I can extract the information that is present and note where the requested information is not applicable or not provided in this type of document.

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

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

This document does not specify formal "acceptance criteria" in terms of clinical performance metrics, as would be common for diagnostic devices. Instead, the performance is demonstrated through theoretical comparisons to predicate devices for mechanical equivalence.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a mechanical device. The "test set" here refers to theoretical comparisons and bench testing, not a clinical study with a patient sample size.
• Data Provenance: Not applicable. The "theoretical comparisons" would be based on engineering principles and potentially prior testing data of predicate devices.

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. This is not a diagnostic device where "ground truth" would be established by experts interpreting images or clinical outcomes. The equivalence is based on engineering and material science.

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

• Not applicable. There is no adjudication needed for mechanical equivalence testing as described here.

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 hardware bone fixation device, not an AI-powered diagnostic tool. An MRMC study is not relevant.

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

• Not applicable. This is a hardware device; there is no algorithm or AI component.

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

• Not applicable. As noted, "ground truth" as typically defined for diagnostic performance is not relevant for this type of device submission. The "truth" is established through engineering specifications and mechanical testing to demonstrate equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or "ground truth" in this context.

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The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available in flat, dome and bowl configurations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Monster Screw System™":

It is important to note that this submission (K124027) is for a medical device (bone fixation screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical AI/SaMD study parameters (like multi-reader multi-case studies, standalone performance, training sets, ground truth methodology for AI models, etc.) are not applicable in this context. The "acceptance criteria" and "study" refer to mechanical performance testing against established industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact number of screws or tests performed. It generically states "Mechanical testing of the worst case Monster Screws."
• Data Provenance: Not applicable in the context of mechanical testing of physical devices. The testing was performed on newly manufactured devices.

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

Not applicable. Ground truth for mechanical testing is established by compliance with a predetermined engineering standard (ASTM F543), not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable for mechanical testing. Data is quantitative and compared directly to the specified standard.

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, an MRMC study was not done. This device is a bone fixation screw system, not an AI/SaMD.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for determining device performance was compliance with the specified mechanical testing standards: ASTM F543 (Standard Specification for Metallic Medical Bone Screws). This standard provides quantitative thresholds and methodologies for measuring torsion, insertion/removal force, and pullout strength.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for mechanical testing of physical devices.

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

Not applicable. There is no training set.

Summary of the Study Proving Acceptance Criteria:

The study conducted to demonstrate that the Monster Screw System™ meets the acceptance criteria was focused on mechanical performance testing.

• Study Design: Mechanical testing was performed on "worst case Monster Screws." The specific test methodologies were in accordance with ASTM F543.
• Tests Performed:
  • Torsion testing
  • Insertion/removal testing
  • Pullout testing
• Acceptance Criteria: The device's performance was considered acceptable if its mechanical properties (torsion, insertion/removal, pullout) were "substantially equivalent" to predicate devices, as demonstrated by the results of the ASTM F543 tests. This implies that the measured values met or exceeded the performance of the predicate devices in these defined mechanical parameters, which themselves would have been shown to meet the ASTM F543 standard.
• Results: The mechanical test results, along with "theoretical comparisons," "demonstrated that the Monster Screw System™ mechanical performance is substantially equivalent to the predicate devices."
• Conclusion: Based on these mechanical tests, the sponsor concluded that the device possesses the same technological characteristics (including performance) as the predicate devices and is therefore substantially equivalent for its intended use.

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