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The Sure-Lok C Extended Tab PSS 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sure-Lok C Extended Tab Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

The Sure-Lok C Extended Tab PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of cannulated and non-cannulated pedicle screws, straight and pre-curved rods, and locking cap screws. All components are available in a variety of sizes to match more closely the patient's anatomy. The Sure-Lok C Extended Tab PSS System is suitable for the following procedures: open, mini-open, percutaneous MIS approach, or a combination of any during the same procedure. All components are made from medical grade stainless steel, titanium or titanium alloy which comply with such standards as ASTM F-138, ASTM F-136, ISO5832-1 or ISO5832-3. All components are supplied clean and "NON STERILE."

The provided text is a 510(k) summary for a medical device (Sure-Lok C Extended Tab Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding clinical study performance, sample sizes, expert ground truth, and comparative effectiveness is not applicable or not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found for an AI/algorithm-based device. Instead, it focuses on compliance with established engineering standards for mechanical and material properties.

The justification for meeting these criteria is a statement of compliance with these recognized standards, rather than presenting detailed test reports. The document states: "Consistent with FDA's guidance document entitled "Use of Standards in Substantial Equivalence Determinations" (...) Precision Spine is including this statement that the Sure-Lok C Extended Tab Pedicle Screw System complies with the following recognized standards instead of providing the test reports demonstrating compliance with these standards."

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

Not applicable/Not available. No clinical test set or data provenance from patients is mentioned. The "study" here is demonstrating compliance with engineering standards.

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

Not applicable/Not available. No expert review or ground truth establishment relevant to an AI/algorithm is described. The ground truth for this type of device is compliance with material and mechanical standards.

4. Adjudication method for the test set

Not applicable/Not available. There is no test set in the context of an algorithm's performance review.

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/Not available. This device is a pedicle screw system, a physical implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant to its approval.

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

Not applicable/Not available. This device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's approval is based on:

• Compliance with recognized engineering and material standards: ASTM F-138, ASTM F-136, ISO5832-1, ISO5832-3, and ASTM F1717-12. This establishes the physical and mechanical properties.
• Substantial Equivalence to predicate devices: The modifications (slightly increased length of extended tab screw, changed rod edges) are deemed not to raise new questions of safety or effectiveness because "The Sure-Lok C Extended Tab Pedicle Screw System has the same intended use and fundamental scientific technology as our previously cleared Pedicle Screw System devices."

8. The sample size for the training set

Not applicable/Not available. There is no "training set" in the context of a pedicle screw system as it is not an AI or learning algorithm.

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

Not applicable/Not available. As there is no training set for an AI, this question is not relevant.

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The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure.

The device description of the Sure-Lok™ secondary needle kit is as follows.

• Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u
• Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment.
• Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure.
• . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath.
• Individually packaged and sterilized. l

This submission (K021315) for the Sure-Lok™ secondary needle kit is a 510(k) Pre-Market Notification, indicating it's a submission for substantial equivalence to a predicate device. As such, the document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing acceptance criteria and proving the device meets them through a specific study in the same way a novel device might.

The provided text, therefore, does not contain detailed information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Specific ground truth types for performance studies.
• Training set sample size or ground truth establishment for a training set.

Instead, the submission demonstrates substantial equivalence by comparing the Sure-Lok™ device to two predicate devices (NeedleTrap™ [K950098] and Point-Lok™ [K946289]) across various characteristics.

Here's a summary of what is provided regarding the device's characteristics and its comparison to predicate devices, which implicitly serves as the "proof" of meeting the standards set by already approved devices:

1. Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence):

The "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The Sure-Lok™ device is deemed acceptable because it shares the same intended use, technique, safety features, and material properties as the legally marketed predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on demonstrating substantial equivalence to already approved predicate devices based on design and material comparisons, not a new performance study with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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 device is a mechanical needle safety device, not an AI-assisted diagnostic tool.

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: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, against which the Sure-Lok™ device is compared. Its compliance with the general controls and regulations for hypodermic single lumen needles, as affirmed by the FDA, serves as validation.

8. The sample size for the training set: Not applicable.

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

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