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The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.

The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.

The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

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

This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.

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. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.

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

This question is not applicable as the device is a physical medical connector, not an AI algorithm.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable as there is no training set for a physical medical device.

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When intended to promote fusion of the cervical spine (Cl-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies)

-Spondylolisthesis

-Spinal Stenosis

-Fracture/dislocation

-Revision of previous cervical spine surgery

-Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and Hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium allov. The components will be provided non-sterile.

The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System," a spinal interlaminal fixation orthosis. However, this document does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

Instead, the document primarily focuses on establishing substantial equivalence for a physical medical device (spinal fixation system) to existing predicate devices.

Here's a breakdown of why it doesn't fit the requested criteria:

• Type of Device: The device described is a physical implant (polyaxial screws, rods, hooks) for spine stabilization, not an AI/ML algorithm or software.
• Performance Data: The "Performance Data" section explicitly states, "Risk analysis was conducted and led to the determination that additional mechanical testing is not required in order to establish the substantial equivalency of the subject devices to the predicate devices." This indicates that no new performance study (like a clinical trial or algorithm performance evaluation) was conducted or detailed in this document to assess specific acceptance criteria. Substantial equivalence was based on technological characteristics and mechanical engineering analysis, comparing it to existing, already approved devices.
• Missing Information: All points requested in your prompt (table of acceptance criteria, sample size, data provenance, expert numbers, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are entirely absent because they are relevant to validating an AI/ML device, not a physical implant's substantial equivalence.

Therefore, I cannot extract the requested information from this document. This document is a regulatory submission for a traditional medical device, not an AI/ML product.

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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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When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.

The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System." This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance data for a standalone device in a clinical setting.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, and human-in-the-loop performance, are not applicable or not available in this type of submission.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where the requested details are not relevant to this submission:

1. Table of acceptance criteria and reported device performance:

This device is a spinal implant for fixation. The "acceptance criteria" here relate to meeting the performance characteristics of predicate devices through mechanical testing and demonstrating substantial equivalence in design, materials, and intended use. The performance is reported in terms of passing these mechanical tests.

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

• Sample Size: Not applicable in the context of clinical data for diagnostic or AI performance. The "test set" here refers to the physical samples of the device components subjected to mechanical testing. The document does not specify the number of individual components tested but implies sufficient testing to meet ASTM F1717 standards.
• Data Provenance: Not applicable in the context of clinical data. The mechanical testing was performed in a lab setting.

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

• Not applicable. This submission does not involve clinical data requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is adherence to established mechanical testing standards (ASTM F1717).

4. Adjudication method for the test set:

• Not applicable. This submission does not involve clinical data requiring adjudication. Mechanical test results are objective measurements against defined 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. This is not an AI or diagnostic device. It's a spinal implant. MRMC studies are not relevant to this type of device submission.

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

• No. This is not an AI or algorithm-based device. "Standalone" performance as a diagnostic algorithm is not applicable. The device's "standalone" performance is its mechanical integrity under various loads, which was tested.

7. The type of ground truth used:

• Mechanical Testing Standards (ASTM F1717): The "ground truth" for this device's performance relies on its ability to withstand specified mechanical forces and stresses according to a recognized standard (ASTM F1717). This standard dictates the test methods and performance metrics for spinal implant constructs.
• Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications, anatomic sites, performance, and material of manufacture.

8. The sample size for the training set:

• Not applicable. This submission does not involve an AI model or a "training set" in the context of machine learning.

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

Summary of the K112025 Submission:

This 510(k) submission for the Sure Lok Mini Posterior Cervical/Upper Thoracic System focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

• Matching Intended Use and Indications: The device shares the same intended use and indications for fusion of the cervical spine as its predicates.
• Similar Design and Materials: The components (polyaxial screws, rods, hooks) are described as similar in design concept, screw thread type, size, length, locking mechanisms, torque, angulation, and dimensions to predicate systems. All components are fabricated from titanium alloy, the same material as the predicates.
• Mechanical Testing: Performance was verified through mechanical testing performed according to ASTM F1717, a recognized standard for spinal implant constructs. This testing confirmed the device's mechanical integrity under static and dynamic axial compression bending and torsion, demonstrating comparable performance to predicate devices.

The information provided does not pertain to the evaluation of a diagnostic device or an AI algorithm, but rather a physical implant device where regulatory clearance relies on established engineering principles and comparison to existing, cleared products.

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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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