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The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.

Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.

The document describes a 510(k) premarket notification for the "Steribite®" manual rongeur, which is a device used in surgery involving the skull or spinal column. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "the subject device models, 1-5 mm bite sizes and 8-11 in handles," but does not explicitly state the number of samples (individual devices) used for each mechanical test.
• Data Provenance: The data is generated from laboratory testing of the device itself. There is no mention of country of origin for data or whether it's retrospective or prospective, as it pertains to device performance testing rather than clinical data.

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

This section is not applicable to this submission. The "Steribite®" is a manual surgical instrument, and its performance and safety validation relies on non-clinical mechanical, sterilization, packaging, and biocompatibility testing against established industry standards and comparison to a predicate device. There is no mention of "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy, as would be relevant for software or diagnostic devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints, which are not part of this 510(k) submission for a manual surgical instrument.

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, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/radiology devices where human readers' performance is augmented by AI. The Steribite® is a manual surgical rongeur, not an AI or diagnostic device that involves human readers.

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

No, a standalone study was not performed. This device is a manual surgical instrument and does not incorporate an algorithm or AI component.

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

This section is not applicable in the traditional sense. The "ground truth" for the non-clinical tests conducted is defined by established engineering principles, industry standards (e.g., ISO, AAMI, ASTM), and the expected performance characteristics of a manual rongeur compared to its predicate. For example, for "cut performance," the ground truth is a "full profile cut in simulated use" as per a specific test standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical surgical instrument and does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As there is no training set, there is no ground truth established for one.

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The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Navigated Instrument System is comprised of manual surgical instruments for use with the BrainLab VectorVision System and the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.

The Navigated Instrument System Medtronic compatible instruments are comprised of Bone Awl, Bone Taps, and Bone Probes only.

The Navigated Instrument System BrainLab compatible instruments are comprised of Bone Awl. Bone Taps, Bone Probes and a variety of Screw Drivers.

The provided text is a 510(k) summary for a medical device called the "Navigated Instrument System." This document aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a device meets specific performance acceptance criteria through clinical studies in the typical sense (e.g., diagnostic accuracy on a test set).

Here's an attempt to answer your questions based on the available information, noting that much of it is not explicitly stated in this type of regulatory document:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence based on "compatibility, accuracy, function and performance."

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 mentions "Engineering analysis and performance data" and "non-clinical test." This implies in-vitro or bench testing rather than studies involving patient data. Therefore:

• Sample size for the test set: Not specified, but likely refers to a set of instruments/fixtures used for bench testing, not human subjects or patient data.
• Data provenance: Not explicitly stated, but given it's a 510(k) submission from Orthofix Inc. in Lewisville, Texas, the testing was likely conducted in the US or by an affiliated entity. The data would be non-clinical/bench testing data, not clinical in retrospect or prospect.

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)

This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" in this context would typically refer to clinical data or expert consensus on diagnoses, which is not what was used given the "engineering analysis and performance data" for a surgical instrument system. The ground truth for bench testing would be defined by metrology standards or physical measurements.

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

Not applicable or not provided. This usually refers to how disagreements among expert readers are resolved in diagnostic image interpretation studies. Since this device relates to surgical instrumentation and its performance was assessed via engineering analysis, such a method would not be used.

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 a surgical instrument system, not an AI-powered diagnostic device. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not performed.

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

Not applicable. This device is an instrument system, not an algorithm. Its function is to assist a human surgeon. Standalone performance as an algorithm would not be relevant.

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

The ground truth for the "engineering analysis and performance data" would be based on physical measurements and engineering specifications. For example, the accuracy of instrument tip localization might be verified against known physical coordinates or measurements of a phantom. It is not clinical ground truth like pathology reports or patient outcomes.

8. The sample size for the training set

The concept of a "training set" is primarily relevant for machine learning or AI models. This device is a traditional mechanical/navigated instrument system. Therefore, there is no training set in the AI sense. The "training" for the system would involve calibration procedures and design verification.

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

As there is no training set in the AI context, this question is not applicable. The design and performance were validated against engineering principles and predicate device characteristics.

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