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TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities.

The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.

The TriMed RipCord Screw is a single-use, sterile, non-absorbable implantable device designed to aid in the treatment of syndesmotic injuries of the lower extremities. The device consists of a far button, an ultra-high molecular weight polyethylene (UHMWPE) suture, and a cannulated screw.

The provided document K251134 is an FDA 510(k) Clearance Letter for a medical device called "RipCord." This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through non-clinical testing. It does not contain information related to software, imaging, or AI-assisted diagnostic tools. Therefore, many of the requested elements, such as those pertaining to AI model performance, human reader studies, and AI-specific ground truth establishment, are not applicable to this documentation.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided text, while acknowledging the limitations for an AI-centric request.

Acceptance Criteria and Study Proving Device Meets Criteria

The device in question, the TriMed RipCord Screw, is a mechanical implant for bone fixation. The study proving its performance is based on non-clinical bench testing, demonstrating mechanical properties, rather than clinical efficacy or diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were established to demonstrate performance equivalence to the predicate device cleared under K220650. However, the specific numerical acceptance criteria values are not detailed in this public FDA clearance letter. Similarly, the exact numerical reported performance values are not provided; only a qualitative statement that the device "successfully met the established acceptance criteria" is present.

Here's a generalized table based on the information provided:

Note: The document explicitly states: "Clinical studies were not conducted for the subject devices." This means the "acceptance criteria" and "device performance" relate solely to the mechanical properties as demonstrated through bench testing, not clinical outcomes or diagnostic accuracy.

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

• Sample Size: The specific sample sizes for the non-clinical tests (static loading, cyclic endurance, torsional strength, driving torque, axial pullout) are not specified in the provided document. The document simply states "TriMed RipCord Screw devices were subjected to static loading and cyclic endurance testing" and "TriMed Cannulated Hex 3.2mm screws were subjected to torsional strength, driving torque and axial pullout tests."
• Data Provenance: The data provenance for this in-vitro, non-clinical bench testing does not involve patient data or geographical origin in the context of clinical studies. It is based on laboratory testing performed by the manufacturer (TriMed, Inc.). The testing is by its nature prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable as the document describes a mechanical device cleared based on non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" for these tests would be the measured physical properties of the materials and device, compared against pre-defined engineering and performance specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or adjudication of medical data. The results of mechanical tests are objective measurements, not subjective interpretations requiring adjudication.

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

This question is not applicable. The device is a bone fixation implant, not an AI-assisted diagnostic tool. No MRMC study was conducted, as confirmed by the statement "Clinical studies were not conducted for the subject devices."

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

This question is not applicable. The device is a bone fixation implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on engineering specifications and mechanical property measurements. The device's performance was compared to that of a predicate device (K220650) to demonstrate "performance equivalence." This is an in-vitro, physical/mechanical ground truth, not a clinical, pathological, or outcomes-based ground truth.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as the device is a mechanical implant, not an AI model or software algorithm that undergoes machine learning training.

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

This question is not applicable for the reasons stated in point 8.

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The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.

The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.

The document discusses:

• The device's intended use for ankle syndesmosis and fractures.
• The device's components and materials.
• A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
• Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML).
2. Sample size used for the test set and data provenance (for AI/ML).
3. Number of experts used to establish ground truth and their qualifications (for AI/ML).
4. Adjudication method (for AI/ML).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
6. If a standalone (algorithm only) performance study was done (for AI/ML).
7. The type of ground truth used (for AI/ML).
8. The sample size for the training set (for AI/ML).
9. How the ground truth for the training set was established (for AI/ML).

The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.

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The Hercules® Syndesmosis Implant System is intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.

The In2Bones Hercules® Syndesmosis Implant System is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two low profile titanium alloy buttons, designed to complement plate fixation or to allow use as a stand-alone device. This device is also packaged with various ancillary instruments to aid in insertion.

The provided text describes a 510(k) premarket notification for the "Hercules® Syndesmosis Implant System." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets clinical acceptance criteria.

Therefore, the information required to answer the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in the provided text.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's determination of substantial equivalence for the Hercules® Syndesmosis Implant System (K220260) to previously cleared predicate devices.
• Device Description: A sterile, single-use system composed of UHMWPE suture and titanium alloy buttons, intended to stabilize syndesmotic trauma of the ankle.
• Indications for Use: Providing fixation during healing after syndesmotic trauma (e.g., Weber B and C ankle fractures) and as an adjunct in other fixation systems, as well as for fixation after joint reconstruction in the midfoot and forefoot.
• Basis for Substantial Equivalence: Similarities in indications, materials, and geometry to predicate devices (e.g., Arthrex Tightrope, Wright Medical Gravity Syndesmosis LP, Arthrosurface KISSLoc Suture System).
• Performance Testing (Bench Testing): Mentions "Cyclic displacement and load to failure bench testing (mechanical testing)" was performed and "The Hercules® Syndesmosis Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization, ISO 11135 for ETO sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72." This refers to engineering/mechanical/biocompatibility testing, not clinical performance data or studies involving human subjects/readers.

In summary, there is no information in this document about studies that prove the device meets acceptance criteria in a clinical or AI-assisted context, as the questions imply. The document pertains to the regulatory clearance process for a medical implant based on substantial equivalence, relying on mechanical and material testing, not diagnostic performance or human reader studies.

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