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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 stainless steel per ASTM 138. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

This document is a 510(k) premarket notification for the "Frontier Medical Devices In-Line Orthopedic Cable Cerclage System." It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and device performance as one might find for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, and related elements will largely be absent or inapplicable in the context of this document. However, I can extract the relevant information that is present:

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

This document describes a medical device, not an AI or software algorithm. Therefore, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or accuracy for an AI system. The "performance" assessment is based on demonstrating substantial equivalence through non-clinical testing.

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

This document does not describe a test set or data provenance in the context of an AI/software study. The "testing" mentioned refers to mechanical bench testing of the physical medical device. The exact sample sizes or specific details of these non-clinical tests are not provided in this summary.

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):

This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm requiring expert ground truth for a diagnostic task.

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

This is not applicable for the reasons stated above.

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 is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.

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

This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.

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

For a physical device like this, "ground truth" relates to the mechanical properties and performance established through engineering standards and testing protocols (e.g., ASTM standards for material strength and fatigue testing). The specific details of these standards and results are not fully disclosed in this 510(k) summary but are fundamental to demonstrating substantial equivalence.

8. The sample size for the training set:

This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

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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 Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following:
· Defect of the pars interarticularis
· Spondylolisthesis
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

The Posterior Cable Screw System consists of screws, cables, and grommets utilized for the correction of pars defects. A construct consists of two cable screws with locking set screws and a cable connecting the two screws. The screws are inserted into the pedicles and the cable is passed around the spinous process between the two screws. The grommet surrounds the cable at the location of the spinous process. The cable is tensioned and the set screws are tightened and fully locked per the surgical technique. The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The implants are provided sterile. The Posterior Cable Screw System utilizes Class I manual instruments to facilitate implantation of the device components.

This document is a 510(k) premarket notification from the FDA regarding the "Frontier Medical Devices Posterior Cable Screw System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant. Therefore, most of the requested information (sample sizes, expert adjudication, MRMC studies, standalone performance for an algorithm, ground truth methods for AI, training set sizes) is not applicable or present in this given text.

However, I can extract the relevant information from the provided text regarding the device's performance in the context of substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device seeking substantial equivalence, "acceptance criteria" and "reported device performance" are evaluated in the context of mechanical and material properties similar to predicate devices, rather than diagnostic accuracy or algorithmic performance.

Note: The FDA's 510(k) clearance process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing completely new performance metrics. The "acceptance criteria" are therefore framed in terms of equivalence.

The following questions are not applicable to this document as it pertains to a physical medical device (spinal implant system) and not an AI/software device. The document describes pre-clinical performance data (dynamic tests) for mechanical properties, not an algorithm's diagnostic performance.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical bench testing, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and test results, not expert consensus on medical images/data.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" for proving substantial equivalence lies in established engineering standards (ASTM F136, ASTM F90) for materials and mechanical testing methodologies accepted by the FDA for spinal implants.
8. The sample size for the training set: Not applicable. There is no "training set" for physical device manufacturing in this context.
9. How the ground truth for the training set was established: Not applicable.

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The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Ancora system consists of different footprints and heights to provide options that correlate best to an individual's anatomy and pathology. The system offers optional integrated locking plates with corresponding locking pins. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and PEEK Optima LT1 per ASTM F2026 with tantalum markers per ASTM F560. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine.

The purpose of this submission is to add implant configurations to the Ancora LLC line of implants, and modify the indications for use so the locking plates are optional fixation devices. Surgical Instruments are also available for use with the system.

This document describes the Ancora LLC Interbody Fusion Device, a medical device designed to facilitate spinal fusion. The information provided outlines its intended use, technical specifications, and the testing conducted to demonstrate its substantial equivalence to previously approved devices.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria Description	Reported Device Performance (from Performance Data section)
   Static Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Dynamic Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Static Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Dynamic Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Expulsion Testing	Conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. Indicated substantial equivalence to predicate devices and adequacy for intended use.

   Note: The document states that the pre-clinical testing "indicated that the Ancora LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use." Specific quantitative performance metrics (e.g., measured load capacities, displacement values) are not provided in this summary, only that the testing was performed according to relevant standards and the results met the criteria for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:
   The provided document describes pre-clinical bench testing (static and dynamic axial compression, static and dynamic compression shear, and expulsion testing) of the device. This type of testing typically involves physical samples of the device itself rather than patient data. Therefore, the concepts of "sample size used for the test set" in terms of patients and "data provenance" (country of origin, retrospective/prospective) are not applicable to this pre-clinical performance data. The testing was conducted on device specimens in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable. As this is pre-clinical bench testing, there is no "ground truth" established by human experts in the way it would be for clinical data interpretation (e.g., radiologists assessing images). The acceptance criteria for mechanical performance tests are defined by ASTM standards and scientific principles, not expert consensus on individual cases.

4. Adjudication Method for the Test Set:
   Not applicable. Since expert human assessors are not involved in establishing ground truth for mechanical bench testing, an adjudication method is not relevant. The results are physical measurements compared against predefined engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No. The document does not describe any MRMC comparative effectiveness study, as the filing pertains to pre-clinical bench testing of a spinal fusion device, not an AI or imaging diagnostic tool.

6. Standalone Performance Study:
   Yes, implicitly. The "Performance Data" section describes pre-clinical bench testing of the Ancora LLC Interbody Fusion Device itself. This testing evaluates the device's mechanical properties and resistance to expulsion in isolation, without human interaction during its function. This is a standalone evaluation of the device's physical performance.

7. Type of Ground Truth Used:
   For the mechanical performance testing, the "ground truth" is defined by the acceptance criteria established by engineering standards (ASTM F2077) and a "recognized protocol" for expulsion testing. The device's performance measurements are compared against these established specifications to determine if they meet the requirements for substantial equivalence.

8. Sample Size for the Training Set:
   Not applicable. This document describes the pre-clinical bench testing of a physical medical device. It does not involve AI algorithms, machine learning models, or the use of training data sets in the computational sense.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable. As there is no training set for the type of device and testing described, the method for establishing its ground truth is irrelevant.

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The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.

This document describes a 510(k) premarket notification for a medical device, specifically an interbody fusion device. The focus is on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy through the detailed acceptance criteria and study designs typically associated with novel drug or high-risk device approvals.

Therefore, the requested information elements (1-9) which are typically relevant for AI/software-as-a-medical-device (SaMD) or clinical trial-based approvals, are largely not applicable in this context. This submission relies heavily on bench testing and cadaveric testing to show that the new device performs similarly to existing, legally marketed devices.

Here's how each point applies to the provided information:

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

Explanation: The acceptance criteria are implicit in the tests performed, which aim to demonstrate that the device's characteristics (materials, dimensions, mechanical strength, stability) are comparable to the predicate devices and suitable for its intended use. The "reported device performance" reflects that the device successfully met the requirements of these tests, confirming its substantial 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 Bench Testing: Not explicitly stated for each test (e.g., number of specimens tested for axial compression). Common for mechanical testing, a sufficient number of samples would be chosen to ensure statistical significance where applicable or to meet the requirements of the ASTM standards.
• Sample Size for Cadaveric Testing: Not explicitly stated (e.g., number of cadaveric spines/specimens).
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by or for Frontier Medical, LLC. This is pre-clinical data, not patient-derived data, therefore "country of origin of the data" and "retrospective or prospective" are not applicable in the patient data sense. The testing is essentially prospective in that it's designed and executed to evaluate the new device.

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. For a 510(k) submission based on bench and cadaveric testing of a mechanical implant, "ground truth" as it relates to expert clinical opinion or diagnostic accuracy is not relevant. The "ground truth" for the performance is derived directly from physical measurements and observations during the standardized mechanical and cadaveric tests. While engineers and possibly surgeons (for cadaveric implantation) would be involved, they are performing objective measurements and procedures, not establishing a "ground truth" from subjective assessment.

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

• Not Applicable. This concept is relevant for studies involving human assessment of images or clinical outcomes where discrepancies need resolution. For bench and cadaveric testing, results are objective measurements or observations; "adjudication" in this sense isn't used. Test procedures follow established standards (e.g., ASTM F2077-03, ASTM F2267-04) for consistency.

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 type of study is specific to diagnostic aids, often AI-powered, where human readers interpret medical images. The Frontier LLC Interbody Fusion Device is a physical implant for spinal fusion.

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

• Not Applicable. This is relevant for AI algorithms. The Frontier LLC Interbody Fusion Device is a physical medical implant.

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

• Ground Truth for Bench Testing: Established by adherence to industry-standard ASTM test methods and direct physical measurements (e.g., load, displacement, cycles to failure). The "ground truth" is the quantitative result of these standardized mechanical tests.
• Ground Truth for Cadaveric Testing: Established through direct observation and qualitative assessment of implantation safety, stability, and freedom from loosening/dislodgement in human cadaveric spines, likely performed by skilled surgeons or biomechanical engineers.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm or statistical model for this device. The device itself is directly tested.

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

• Not Applicable. As there is no training set, this question is not relevant.

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