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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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