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The VENUS BASIC Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graff having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS BASIC Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism.

The VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implants components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

The purpose of this submission is to add components of the cannulated polyaxial pedicle screws in VENUS BASIC Spinal Fixation System. Various sizes of these implants are available.

The provided text is a 510(k) summary for the VENUS BASIC Spinal Fixation System. This type of submission is for medical devices seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics typically associated with AI/ML-driven devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML algorithm's performance.

Instead, this document focuses on:

• Device Identification: Trade name, common name, classification, and product codes.
• Predicate Devices: Listing of previously cleared devices to which the current device claims substantial equivalence.
• Device Description: What the device is (posterior spinal fixation system) and its components (pedicle screws, rods, set screws, transverse linking mechanism). It also mentions the purpose of the submission is to add cannulated polyaxial pedicle screws.
• Indications for Use: The medical conditions and patient populations for which the device is intended.
• Performance Data (Mechanical Testing): States that mechanical testing was conducted according to ASTM F 1717 to demonstrate equivalence to predicate devices in terms of static compression/tension/torsion and fatigue. This is a common requirement for spinal implants but is not a clinical study proving performance against defined acceptance criteria for AI/ML.

In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC/standalone performance relevant to an AI/ML device is present in this 510(k) summary.

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The VENUS BASIC Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS BASIC Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the VENUS BASIC Spinal Fixation System

Here's a breakdown of the acceptance criteria and study information for the VENUS BASIC Spinal Fixation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily focuses on demonstrating substantive equivalence through mechanical testing, rather than setting specific numerical performance thresholds for the device itself. The acceptance criteria are implicitly met by demonstrating that its mechanical properties are comparable to legally marketed predicate devices.

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

The document does not specify a "test set" in the context of clinical data or human evaluations. The performance data presented refers to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated in terms of number of devices or components. It's generally understood that mechanical tests adhering to ASTM standards involve a sufficient number of samples to ensure statistically sound results, but the exact count is not provided.
• Data Provenance: The mechanical testing was conducted in accordance with ASTM F1717-04. This is a recognized international standard for spinal implant testing. The tests would likely have been performed in a laboratory setting, presumably by or for the manufacturer (Implanova Co.,Ltd. / L&K BIOMED Co., Ltd. in Republic of Korea). The data is generated prospectively for the purpose of regulatory submission.

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

This information is not applicable to this 510(k) submission. The "ground truth" here is established through physical mechanical testing according to an engineering standard (ASTM F1717-04), not through expert clinical interpretation or consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human readers/evaluations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (spinal fixation system) and relies on mechanical testing to demonstrate substantial equivalence, not clinical effectiveness studies with human readers interpreting results.

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

This question is not applicable. The device is a physical pedicle screw spinal fixation system, not an algorithm or AI software. Therefore, there is no "standalone performance" of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's performance is based on objective measurements derived from mechanical testing protocols (ASTM F1717-04). This standard sets forth the methods for evaluating static and fatigue properties of spinal implant constructs, and the reported equivalence to predicate devices serves as the truth for regulatory purposes.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device, as it is a physical implant and not an AI/ML model.

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

This information is not applicable for the same reasons as #8.

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