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KangLi® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 – S1.

The spinal system consists of pedicle screws, nuts, rods and crosslink etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text describes the 510(k) premarket notification for the KangLi® Pedicle Screw Spinal System. This is a medical device for spinal fixation, and the document focuses on demonstrating its substantial equivalence to a predicate device, rather than proving a new or novel performance against specific acceptance criteria for a diagnostic or AI-driven medical device.

Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance like sensitivity/specificity, sample size for test sets, expert qualifications for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document because it pertains to a mechanical spinal implant, not a diagnostic or AI-assisted device assessed by such metrics.

The "Non-Clinical Testing" section (item 6) refers to bench tests to ensure the device meets design specifications and is substantially equivalent to the predicate. These tests are mechanical in nature, verifying physical properties and performance under stress, not diagnostic accuracy.

Here's a breakdown of what is available from the text relevant to mechanical equivalent performance:

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

2. Sample sized used for the test set and the data provenance: Not applicable. These were bench tests, not clinical studies involving patient data or test sets for diagnostic performance.

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 established by engineering standards and measurements, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to diagnostic study design, not mechanical testing.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is defined by the objective physical measurements and material properties specified in the ASTM and ISO standards (e.g., strength parameters, biocompatibility, sterilization efficacy).

8. The sample size for the training set: Not applicable. No training set for an AI or diagnostic algorithm was used.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical implant through adherence to established material and mechanical performance standards, not on diagnostic or AI performance metrics.

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KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.

KangLi® locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery. The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6AI4V ELI that meets to ASTM F136. The materials of titanium and Ti6AI4V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

The provided text describes the 510(k) submission for the KangLi® Locking Plate System, a medical device for bone fixation. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

The document is a traditional 510(k) summary for a physical medical device (locking plates and screws), not a software or AI/ML device. Therefore, the questions related to AI/ML device evaluation (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

Instead, this submission focuses on bench testing to demonstrate Substantial Equivalence (SE) to a predicate device. The "acceptance criteria" here are the performance requirements outlined in the referenced ASTM standards.

Here's a breakdown of the information that can be extracted from the provided text, modified to fit the context of device performance, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. For bench testing of physical orthopedic implants, sample sizes are typically determined by relevant ISO/ASTM standards or internal company protocols to ensure statistical significance for mechanical properties. These are usually small numbers (e.g., 5-10 samples per test arm) rather than large datasets.
• Data Provenance: Not applicable in the context of "country of origin of data" or "retrospective/prospective" as this refers to mechanical bench testing, not clinical or image data. The testing was conducted by Suzhou Kangli Orthopaedics Instrument Co., Ltd., which is based in China.

3. 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 measured physical properties of the device meeting the specified ASTM standards. This is determined by engineering measurements and quality control processes, not expert clinical interpretation.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing involves objective measurements against predefined thresholds, not subjective adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating the diagnostic performance of a device (often AI/ML systems) with human readers. The KangLi® Locking Plate System is a physical implant, not a diagnostic tool.

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

• No. This relates to AI/ML algorithms. The KangLi® system is a physical implant. Its performance is inherent in its mechanical properties.

7. The type of ground truth used:

• Engineering/Mechanical Specifications: The "ground truth" for this device's performance is adherence to the mechanical performance specifications defined by the ASTM standards (F 382-99 and F 543-07). This includes properties like static and dynamic bending strength for plates, and torsional properties, driving torque, and pull-out strength for screws.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical medical device being evaluated through bench testing. The design of the device is based on engineering principles and knowledge of materials, not machine learning algorithms.

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

• Not applicable, as there is no training set.

In summary: The provided text details the non-clinical bench testing conducted to demonstrate that the KangLi® Locking Plate System structurally performs in accordance with established ASTM standards for metallic bone plates and screws. This type of regulatory submission focuses on mechanical and material properties to prove "Substantial Equivalence" to a previously approved device, not on diagnostic accuracy or AI/ML performance. Therefore, most of the questions are not relevant to this specific document.

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KangLi® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of pedicle screws, nuts and rods etc. It is made of titanium alloy (Ti6AI4V ELJ), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products - Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided document describes a 510(k) premarket notification for the KangLi® Pedicle Screw Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical utility through extensive clinical trials. Therefore, the information provided primarily addresses bench testing to meet design specifications and demonstrate equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of devices or constructs) used for the bench tests. It only states that "Bench tests were conducted."
• Data Provenance: The tests were conducted internally by the manufacturer (Suzhou Kangli Orthopaedics Instrument Co., Ltd.) to verify design specifications and substantial equivalence to the predicate device. This is a form of retrospective data analysis in the sense that the tests are performed on manufactured devices. The country of origin of the manufacturer is China.

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

• Not Applicable. For a 510(k) submission based on substantial equivalence and bench testing, expert review to establish "ground truth" in the clinical sense (e.g., diagnosis, outcome) is not typically required. The "ground truth" here is adherence to recognized industry standards (ASTM F1717-13) and successful completion of the specified mechanical tests, which are objective measurements.

4. Adjudication Method for the Test Set

• None. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's subjective interpretation involved, such as reading medical images. This document describes bench testing, which involves objective, quantifiable measurements against established standards.

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

• No. An MRMC study is relevant for AI/radiology systems involving human readers. This document is for a physical medical implant (pedicle screw spinal system) and does not involve AI or human image interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No. This question is also relevant for AI-powered devices. The subject device is a hardware implant, not a software algorithm.

7. The Type of Ground Truth Used

• Objective Measurements Against Industry Standards: The "ground truth" for the performance evaluation in this submission is compliance with the mechanical performance requirements defined in the ASTM F1717-13 standard. For material properties, it's meeting ASTM F136 for titanium alloy composition and for sterilization, it's meeting ISO 17665-1.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of device approval through bench testing for substantial equivalence. This concept applies to machine learning models.

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

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

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