ACROMED PEDICLE SCREW by ACROMED CORP.

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.

Device Description

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.

AI/ML Overview

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:

Aspect	Information Provided
1. Acceptance Criteria and Reported Device Performance
Acceptance Criteria	"Perform consistently with previously cleared components" (specifically regarding static and fatigue testing).
Reported Device Performance	"Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components."

2. Sample size used for the test set and data provenance	Not provided in the text. This type of detail would be in a full testing report, not a 510(k) summary.

3. Number of experts used to establish ground truth for the test set and qualifications	Not applicable. This document refers to mechanical testing, not a clinical study involving human experts for "ground truth" in the diagnostic sense.

4. Adjudication method for the test set	Not applicable (mechanical testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done	No. This is a medical device for implantation, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done	Not applicable. This is a physical medical device. The "standalone" concept usually applies to AI algorithms.

7. The type of ground truth used	For mechanical testing, the "ground truth" would be established engineering standards, material properties, and comparative performance data of the predicate device. Specific methodologies are not detailed.

8. The sample size for the training set	Not applicable. This refers to the manufacturing and testing of a physical product, not an AI model.

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

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.

Summary

{0}------------------------------------------------

MAY - 8 1997

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K965102

VSP SYSTEM AcroMed Pedicle Screw (4.75 mm) 510(k) SUMMARY

: .

COMPANY:	AcroMed Corporation3303 Carnegie AvenueCleveland, OH 44115
TRADENAME:	AcroMed Pedicle Screw
CLASSIFICATION:	Spondylolisthesis Spinal Fixation DeviceUnclassified, preamendment device system
DESCRIPTION:	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.
MATERIAL:	The AcroMed Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications.

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INDICATIONS:

PERFORMANCE DATA:

Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components.

SUBSTANTIAL EQUIVALENCE:

The AcroMed pedicle screw (4.75) are equivalent to other AcroMed pedicle screws as cleared under K951116.

Regulation Number and Section

N/A