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The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

The Thorecon Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Pioneer Sternal Cable of similar material.

The Thorecon Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum are manufactured from 420 or Custom 470 stainless steel.

Thorecon Fixation System devices are all single-use. The plates, complete with the necessary screws and instruments (screw driver and tensioner/cutter) required for completion of the surgery are provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.

Here is an analysis of the acceptance criteria and supporting study for the Thorecon™ Fixation System, based on the provided text:

Preamble: The provided document is a 510(k) summary for a medical device (Thorecon™ Fixation System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "study" referenced in the context of this document primarily refers to non-clinical testing performed to show that the new device performs at least as safely and effectively as existing, legally marketed devices. It is not an effectiveness study in the typical sense of a clinical trial demonstrating a new treatment's efficacy.

Acceptance Criteria and Reported Device Performance

• Screw Push-Out of Plate Force Test
• Bone Screw Pull-Out Test per ASTM F543
• Static Tension Testing
• Dynamic Tension Testing |
  | Packaging, Sterility & Shelf Life | Validation completed per standards:
• ISO 11607 (Packaging)
• ASTM D4169 (Shipping Containers)
• ISO 11137-2 (Sterilization Dose)
• ASTM F1980 (Accelerated Aging)
• ISO 17665-1 (Moist Heat Sterilization) |
  | Biocompatibility | Evaluation completed per ISO 10993 (Parts 1, 5, 10, and 11). |
  | Pyrogenicity | Evaluated using Limulus amebocyte lysate (LAL) assay, ensuring endotoxin level meets the requirement of maximum endotoxin limit for implantable medical devices [20 EU per device]. |

Additional Information on the "Study" (Non-Clinical Testing)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify numerical sample sizes for the individual mechanical, packaging, sterility, shelf life, biocompatibility, or pyrogenicity tests. It only states that these tests were performed and "passed acceptance criteria."
   • The data provenance is internal, originating from testing conducted by or for A&E Medical Corporation to support their 510(k) submission. No specific country of origin for the data is mentioned, but the company is based in the USA. The tests are non-clinical (laboratory/bench) studies, not patient data (retrospective or prospective).

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

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" and "experts" are terms typically used in studies involving subjective assessments (e.g., image interpretation, clinical diagnosis) where human judgment needs to be standardized or measured against a gold standard. For engineering and materials testing (mechanical performance, sterility, etc.), the "ground truth" is defined by established scientific principles, validated testing methodologies, and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective observations.

3. Adjudication Method for the Test Set:

   • This is not applicable as the "test set" consists of non-clinical, objective measurements against pre-defined performance standards or predicate device performance, not subjective appraisals requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) interpreting medical images or clinical data, often with and without AI assistance, to assess diagnostic performance. The Thorecon™ Fixation System is a surgical implant; its performance is evaluated through biomechanical and materials testing, not through diagnostic interpretation.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • This question is not applicable as the Thorecon™ Fixation System is a physical medical device (surgical implant), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

6. The Type of Ground Truth Used:

   • The "ground truth" for the non-clinical tests mentioned (mechanical, packaging, sterility, biocompatibility, pyrogenicity) is based on established industry standards (e.g., ASTM, ISO), regulatory requirements (e.g., FDA guidelines), and performance data from predicate devices. For example, for mechanical tests, the ground truth is a specific force or displacement value that the device must withstand or perform to a certain degree. For pyrogenicity, it's a defined endotoxin limit. For biocompatibility, it's compliance with established biological safety profiles.

7. The Sample Size for the Training Set:

   • This question is not applicable. "Training set" refers to data used to train machine learning models. The Thorecon™ Fixation System is a physical medical device, not an AI software, and therefore does not have a "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not machine learning.

8. How the Ground Truth for the Training Set Was Established:

   • This question is not applicable for the same reason as point 7.

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The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.

The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.

The Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments

The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex Button device links the cable and bone screw together. The button is position

hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.

Here's an analysis of the provided text regarding the Hex Button Device's acceptance criteria and study, structured to answer your questions:

The provided 510(k) summary for the Hex Button device (K992617) does not contain information about clinical studies with human readers or AI assistance. The performance data section describes engineering tests to demonstrate the device's mechanical integrity. Therefore, some of your requested information, particularly regarding AI performance, human reader studies, and ground truth for training/testing sets, cannot be extracted from this document as it pertains to a physical medical device, not an AI/Software as a Medical Device (SaMD).

However, I will extract the relevant information that is available:

Acceptance Criteria and Device Performance (Engineering Tests)

Study Details (Based on Available Information)

1. Sample Size used for the test set and the data provenance:

   • The document describes engineering tests, not studies with a "test set" in the context of diagnostic performance (e.g., images for AI).
   • The sample size for these mechanical tests is not explicitly stated (e.g., "N=X Hex Buttons were tested").
   • Data provenance is not applicable since these are laboratory mechanical tests of the physical device components.

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

   • Not applicable. "Ground truth" in this context refers to the outcome of mechanical stress and corrosion tests, evaluated by engineering standards rather than expert clinical consensus.

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

   • Not applicable. These were engineering tests with predefined failure criteria for mechanical properties, not diagnostic performance with subjective interpretation.

4. 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. This is a physical medical device (a surgical hardware component), not an AI/SaMD. MRMC studies are not relevant for this type of device.

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

   • No. This is a physical medical device, not an algorithm. Standalone performance is not applicable.

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

   • For the engineering tests, the "ground truth" was the mechanical failure point observed during static yield and corrosion fatigue tests, as well as the absence of wear/failure on the Hex Button itself. This is determined by material science and engineering principles and measurements.

7. The sample size for the training set:

   • Not applicable. The device is a physical component, not an AI model, so there is no training set.

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

   • Not applicable, as there is no training set.

Summary regarding the nature of the study:

The Hex Button device is a surgical implant component. The "study" described in the 510(k) summary (Performance Data section) consists of benchtop engineering tests for static yield and crevice corrosion fatigue. These tests aimed to demonstrate the physical and mechanical integrity of the Hex Button itself when used in conjunction with a cerclage cable, specifically showing that the Hex Button did not fail and exhibited minimal wear, while the cerclage cable (the component connecting through the button) was the intended failure point under stress.

The submission relies on substantial equivalence to an existing predicate device (Cerclage Cable with Hex Button Device, K974016), leveraging the prior testing and clearance of that predicate. The "Performance Data" is provided to confirm that the Hex Button material and design in this new submission behave identically or acceptably to the previously cleared device.

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