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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 In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade titanium alloy per ASTM F 136, unalloyed titanium per ASTM F 67, and cobalt chromium alloy per ASTM F 90. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

I apologize, but the provided text from the FDA 510(k) K151888 for the "Frontier Medical Devices In-line Orthopedic Cable Cerclage System" does not contain any information about a study involving AI/ML device performance, human expert evaluation, or ground truth establishment.

The document describes a traditional medical device (a cable cerclage system for orthopedic fixation) and its 510(k) clearance process. The performance data mentioned refers to "Static and dynamic testing," which are mechanical bench tests, not clinical studies involving human readers or AI algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-based device from this document. The information you are asking for (e.g., sample size, expert qualifications, MRMC studies, ground truth) is relevant to the evaluation of AI/ML-driven medical devices, which this product is not.

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The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum.

The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.

As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

The AcroMed Cable/Wire Pedicle Screw is a pedicle screw with a modified grooved head and hole through the base of the head. The ISOLA rod is placed on top of the screw so that the rod fits in the groove. The groove is sized to accommodate both the 4.75 mm and 6.35 mm diameter rods.

The AcroMed Cable/Wire Pedicle Screw is intended for use with 18 gauge wire (304.8 mm in length) (K895439), which adjoins the screw to the rod. Alternatively, stainless steel Songer cable (K935481) may be used in place of 18 gauge wire. The wire or cable is threaded through the hole at the base of the screw head and the wire is twisted or the cable is crimped over the top of the rod.

The screw is available in cancellous lengths of 25.0 mm, 30.0 mm, and 35.0 mm.

The AcroMed Cable/Wire Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications. The wire is made from stainless steel conforming to ASTM F1350 specifications. Stainless steel Songer cables are manufactured from stainless steel conforming to ASTM F138 specifications.

This document describes a medical device, the AcroMed Cable/Wire Pedicle Screw, and its intended use with the ISOLA Spine System. The information provided is for regulatory clearance (510(k) summary) and focuses on demonstrating substantial equivalence to previously cleared devices rather than a study proving the device meets explicit acceptance criteria in the context of clinical performance or AI/software.

Therefore, many of the requested categories are not applicable to this type of document, which describes a physical medical implant and its mechanical testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the static and fatigue testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be laboratory-based mechanical testing, not clinical data.

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

• Not Applicable: This device is a mechanical implant. Performance is evaluated through laboratory testing (static and fatigue) against engineering standards or comparison to predicates, not through expert-established ground truth in a clinical or imaging context.

4. Adjudication method for the test set

• Not Applicable: See point 3. Testing is mechanical/laboratory, not based on expert 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

• Not Applicable: This is a physical medical device (pedicle screw), not an AI or imaging-based diagnostic/software device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not Applicable: See point 5.

7. The type of ground truth used

• Implied Ground Truth: For mechanical testing, the "ground truth" would be established engineering standards for strength, fatigue life, and deformation, often compared against predicate devices. The document explicitly states "consistent with previously cleared components."

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning model.

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

• Not Applicable: See point 8.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document states that "Static and fatigue testing show the AcroMed Cable/Wire Pedicle Screw to perform consistent with previously cleared components." This implies a series of mechanical tests (e.g., measuring ultimate tensile strength, yield strength, endurance limit under cyclic loading) conducted in a laboratory environment. The "acceptance criteria" appear to be that the device's mechanical performance should be equivalent to or better than that of predicate devices (other AcroMed pedicle screws cleared under K951657 and the Harrington Lag Screw). However, the specific protocols, loads, cycles, or results of these tests, including the specific quantitative acceptance criteria, are not detailed in this 510(k) summary. This summary serves as an attestation of such testing having been performed and the results being favorable for substantial equivalence.

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