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IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Device Description

Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

AI/ML Overview

The provided text is a 510(k) Summary for the Medtronic POWEREASE™ System. It discusses the device's substantial equivalence to a predicate device, IPC™ POWEREASE™ SYSTEM (K111520), and outlines some performance data. However, it explicitly states that no new testing was performed for the subject devices, and instead relies on a "confirmatory validation" to ensure minor modifications do not introduce new safety or effectiveness issues.

Therefore, the document does not report on a study that establishes acceptance criteria and demonstrates that the device meets those criteria through new performance testing. Instead, it asserts substantial equivalence based on the device being identical to the predicate in key aspects.

Given this, I cannot fully answer all parts of your request as there isn't a detailed study report with new acceptance criteria and performance data in the provided document. I will fill in what can be inferred from the text.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, no specific quantitative acceptance criteria or new device performance metrics are presented for the subject device. The document states that the subject instruments are "identical to the predicate devices in terms of fundamental technology, intended use and indications for use." The "confirmatory validation" is not described with numerical acceptance criteria or performance results.

Acceptance Criteria	Reported Device Performance
Material Composition: Adherence to standards for surgical instruments.	• Manufactured from identical materials as the predicate devices. • Materials meet ASTM F899 (Standard Specification for Wrought Stainless Steels for Surgical Instruments).
Biocompatibility: Safe for limited contact.	• Classified as communicating devices with Tissue/Bone/Dentin (<24h external contact). • Materials have a long history of safe and effective use in predicate spinal implants. • Biocompatibility testing for the subject device was not required as materials are identical to predicate devices.
Functional Equivalence: No new safety or effectiveness issues introduced by minor modifications.	• A "confirmatory validation" was conducted to ensure minor modifications do not introduce new issues of safety and effectiveness and that devices function as intended. • No new testing was performed for the subject devices.

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

The document explicitly states: "Non-clinical mechanical testing was not performed for the subject instruments." Therefore, there is no test set sample size mentioned in relation to new performance data. The "confirmatory validation" is not described in a way that suggests a test set or specific data provenance.

3. 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)

Not applicable, as no new clinical or performance testing requiring expert ground truth establishment for a test set was performed or reported.

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

Not applicable, as no new clinical or performance testing with a test set was performed or reported.

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. The device is a powered surgical system, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a powered surgical system, not an algorithm.

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

Not applicable, as no new clinical or performance testing requiring ground truth was performed or reported for the subject device. The claim of substantial equivalence is based on the known performance and safety history of the predicate device with identical materials and technology.

8. The sample size for the training set

Not applicable, as this is a medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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K Number

K123270

Device Name

POWEREASE SYSTEM

Manufacturer

MEDTRONIC SOFAMOR DANEK USA, INC.

Date Cleared

2013-01-11

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K111520

Predicate For

K140454,K153463,K153587,K201407

Intended Use

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Device Description

The POWEREASE™ System Working Ends consists of instruments such as taps, drill bits, screwdrivers, post cutter, set screw break-off tool, reduction nut driver and sleeves. The working ends have a manual alternative. The working ends, listed above, are compatible with the CD HORIZON® SOLERA® and the TSRH® 3Dx Spinal System implants. Of the working ends, only the taps, screwdrivers, drill bits, and sleeves are also compatible with Medtronic's NIM-ECLIPSE® Spinal System.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the Medtronic Sofamor Danek POWEREASE™ System, which is a surgical instrument system. The content describes the device, its intended use, and a comparison to a predicate device.

Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, as is common in 510(k) submissions, rather than presenting a performance study with specific acceptance criteria and detailed results from a clinical or non-clinical trial against those criteria. Therefore, the requested information about acceptance criteria and a study demonstrating performance against them (especially clinical performance metrics like accuracy, sensitivity, specificity, etc.) is largely absent from this particular document.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., accuracy, sensitivity, precision) that the device must meet, nor does it present a structured report of the device's performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (POWEREASE™ System K111520). The "acceptance" in this context is based on the FDA's determination that the new device does not raise new questions of safety and effectiveness compared to the predicate.

The document states:

"Engineering rationales, based on engineering theoretical analysis, were completed using testing that had been performed on the predicate device."
"The predicate testing was in accordance with IEC 60601 for Medical Electrical Equipment."
"Information and data to support these engineering rationales, as well as surgeon validations and internal verification activities, were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices."

This indicates that the "performance" demonstrated is primarily focused on safety and functional equivalence to the predicate, often through bench testing, materials characterization, and adherence to relevant standards like IEC 60601 for electrical medical equipment (though the specific aspects of IEC 60601 are not detailed, it typically covers electrical safety, electromagnetic compatibility, and basic performance).

Study Details (Based on available information)

Given the nature of a 510(k) summary relying on substantial equivalence, the detailed study information typically associated with AI-driven devices or novel therapies (like sample size, expert ground truth, adjudication) is not present.