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The AcroMed 4.75 mm Pedicle Screw is designed to be utilized with the VSP Spinal Fixation System. The VSP Spinal Fixation System is intended for use in grade 3 or 4 spondylolisthesis at LS-S1, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and plate and it eliminates the "claw hammer" effect associated with other screw designs. The upper surface of the integral nut is a transverse flat smooth surface to provide maximum contact area with the underside of the VSP spine plate.
The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration.
The screw is available in cancellous thread lengths from 25 mm to 50 mm, in 5 mm increments.
The AcroMed Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications.

Here's an analysis of the provided text regarding acceptance criteria and study information for the AcroMed Pedicle Screw (4.75 mm):

The provided text ("K965102") describes a 510(k) summary for the AcroMed Pedicle Screw. However, it does not contain the detailed information requested regarding specific acceptance criteria, performance metrics (like sensitivity, specificity, AUC), study methodology, data provenance, ground truth establishment, or human reader studies.

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, focusing on material, design, and intended use.

Here's a breakdown of what can be extracted and what is missing:

The core of the "Performance Data" section states: "Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components." This implies that the acceptance criteria for this device are met if its static and fatigue performance is consistent with a predicate device (cleared under K951116).

Here's the table based on the provided input, with many fields marked as "Not provided in the text" due to the nature of the document:

Summary of Missing Information and Why:

The provided document is a 510(k) summary for a physical medical device (pedicle screw). It primarily focuses on demonstrating "substantial equivalence" to a predicate device. For such devices, the performance data typically involves:

• Mechanical Testing: Static (e.g., yield strength, ultimate tensile strength) and fatigue (e.g., ability to withstand repeated loads without failure) tests.
• Biocompatibility Testing: Ensuring the material is safe for implantation.
• Sterilization Validation: Ensuring the device can be properly sterilized.

The questions you've asked (about sensitivity, specificity, AUC, expert consensus, MRMC studies, AI training sets, etc.) are highly relevant for diagnostic imaging devices or AI/CAD systems, which often involve interpreting medical images or data. They are not typically applicable to a device like a pedicle screw, where "performance" is measured in terms of mechanical integrity and biological compatibility.

To address your questions fully for this type of device, you would need to examine the full submission, which would include detailed test protocols, results, and standards referenced for the static and fatigue testing.

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The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.

The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and rod and it eliminates the "claw hammer" effect associated with other screw designs. The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration. The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments.

Here's an analysis of the provided text based on your request:

It's important to note that the provided text is a 510(k) summary for a medical device (AcroMed Pedicle Screw) seeking clearance from the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a diagnostic AI device would.

Therefore, many of your requested points will either be "Not Applicable" (N/A) or have limited information available due to the nature of a 510(k) submission for a mechanical implant.

Acceptance Criteria and Device Performance (Based on available information)

Study Details:

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

   • Sample Size (Test Set): Not explicitly stated in terms of patient numbers or specific measurement counts. The "performance data" refers to "static and fatigue testing," which typically involves a specific number of mechanical test specimens (e.g., screws) tested under laboratory conditions. The exact number of screws tested is not provided.
   • Data Provenance: N/A for clinical data. The performance data relates to in vitro mechanical testing, not human patient data. There is no information on the country of origin of this in vitro testing.

2. 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):

   • N/A. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is its physical and mechanical properties measured by engineering tests.

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

   • N/A. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes. The performance data presented here refers to objective mechanical testing.

4. 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:

   • N/A. This study relates to the mechanical performance of a pedicle screw, not a diagnostic AI system or human reader performance.

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

   • N/A. This device is a mechanical implant, not an algorithm.

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

   • For the mechanical performance, the "ground truth" is defined by engineering standards and measurements. This includes ASTM F1314 for material composition and internal mechanical testing protocols for static and fatigue strength, with "consistency" to predicate device performance as the benchmark. For indications for use, the ground truth is established by clinical understanding of spinal conditions like spondylolisthesis.

7. The sample size for the training set:

   • N/A. This device is a mechanical implant, not an AI or machine learning model that requires a "training set."

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

   • N/A. (See point 7).

Summary for K963639 - AcroMed Pedicle Screw (4.75 mm):

This 510(k) summary focuses on demonstrating that the 4.75 mm AcroMed Pedicle Screw is substantially equivalent to previously cleared AcroMed pedicle screws. The "study" described is primarily mechanical performance testing (static and fatigue). The acceptance criteria for this testing is that the new screw performs "consistently with previously cleared components." The sample size for this mechanical testing is not specified, but it would involve a certain number of test specimens. Ground truth is established by engineering standards and comparative mechanical performance metrics. There are no elements related to human readers, AI, or large-scale clinical trials in the provided information.

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