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The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Global AP Shoulder glenoid component, Global Shoulder StepTech Anchor Peg glenoid component, or Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems.

The indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemishoulder replacement. The Indications for Use of these DePuy shoulder systems are:

DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid

The DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from:

· A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis.

· Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory.

· Other difficult clinical problems where shoulder surgery arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

The Global AP Glenoid and StepTech glenoid components are indicated only for use with bone cement.

DePuy Delta Xtend Reverse Shoulder System

· The Delta Xtend Reverse Shoulder prosthesis is intended for use as total shoulder replacement.

· The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.

• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

· In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

· Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.

· The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K123122, except for the following modifications:

• In K123122, the IRI legs were plastic, single use, and were shipped sterile in quantities of 2 of each recommended leg length. In this submission, the IRI legs are stainless steel, reusable, and are shipped non-sterile in the Glenoid IRIS instrument tray/carrier/kit for steam sterilization prior to use at the hospital where the procedure will be taking place. Each Glenoid IRIS kit contains a full set of reusable IRI legs.

• The SmartBone instruments (SmartBone-Pin Trajectory, SmartBone-Reamed, SmartBone-Fixation Feature Prep, and SmartBone-Implant) are made of a different photopolymer from K123122.

-The SmartBone instruments are shipped non-sterile and are sterilized on-site where the procedure will be taking place.

-The IRI wrench was removed from the Glenoid IRIS system and the IRI cap was modified to facilitate tightening and loosening the IRI instrument by hand. The Glenoid IRIS instrument tray was made to include a slot that could be used to replace the disassembly feature of the nubs on the IRI wrench.

-The SmartBone—Pin Trajectory instrument is pre-marked where the recommended IRI legs contact the SmartBone instrument. The marker is a non-toxic marker that is compatible with steam, EO & Sterrad Sterilization. We performed testing to determine how great the risk of the marking from the marker bleeding and or transferring when wiped with a polar and non-polar solvent. The study indicated that the marker was compatible with steam sterilization and did not undergo bleeding. Likewise, the marker did not transfer to a white rag when rubbed with a polar or non-polar solvent.

-The SmartBone mount is made of stainless-steel, is reusable, and is shipped nonsterile as part of the Glenoid IRIS system in a kit/carrier. When the SmartBone is placed on the SmartBone mount, the glenoid is positioned such that vertical is the plane of the scapula. When the SmartBone is set on its base without the SmartBone Mount, the guide pin hole is vertical for ease in setting the IRI.

-The Glenoid IRIS system includes a case/tray carrier for ease in shipping, storing, carrying, and organizing the Glenoid IRI device, the Glenoid IRI legs, the SmartBone instrument (or a place to put the SmartBone instrument, when it arrives after having been shipped separately), and the SmartBone Mount.

-Minor dimensional and aesthetic marking changes to the IRI components

This document describes the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), a patient-specific manual instrument system designed to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin in total shoulder implant systems. The current submission (K142072) is for a modified version of a previously cleared device (K123122), with changes primarily related to material, reusability, and minor dimensional alterations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a formal table format. However, it implicitly defines acceptance by demonstrating "substantial equivalence" to the predicate device (K123122) in performance, biocompatibility, and durability.

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

• Test Set Description: The primary functional performance test involved an "artificial cadaver surgeon evaluation."
• Sample Size: The original Glenoid IRIS was used 5 times on an artificial cadaver, and the modified Glenoid IRIS was also used 5 times on the same artificial cadaver. This constitutes a sample size of n=5 for each device version in the comparative functional test.
• Data Provenance: The data is from a prospective comparison study using an artificial cadaver. The country of origin is not specified but is implicitly within the scope of FDA submission, suggesting a U.S. or U.S.-compliant context.

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

• The document mentions "A simulated use, artificial cadaver comparison test between the original and modified Glenoid IRIS was performed." and refers to "Artificial Cadaver Surgeon Evaluation (Validation)".
• It does not specify the number of experts (surgeons) or their qualifications who performed these evaluations. It only states that the "original Glenoid IRIS was used on an artificial training cadaver of a patient with severe glenoid retroversion five times" and "The modified Glenoid IRIS was also used on this same patient five times."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The comparison was based on "the mean version and inclination of the original and modified Glenoid IRIS" and "the amount of deviation from the planned guide pin location." This suggests a quantitative comparison against a predefined "planned guide pin location" (which implicitly serves as the ground truth), rather than an expert consensus adjudication on the outcome of each individual trial.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance evaluation focused on comparing the modified device's functionality directly against the predicate device's functionality in a simulated environment, not on human readers' improvement with or without AI assistance. The device is a "manual instrument system," implying human-in-the-loop by design.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study was not conducted or described. The device is a "patient specific manual instrument system," inherently designed for human-in-the-loop use. The evaluation involved a "surgeon evaluation" using the instruments.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the functional performance test (artificial cadaver surgeon evaluation), the ground truth was the "planned guide pin location." The deviation from this planned location was a key metric. This "planned location" would typically be established during the preoperative planning phase, likely based on surgical principles and potentially anatomical data, though the exact method of establishing this ground truth for the artificial cadaver is not detailed.
• For biocompatibility, the ground truth was established by standardized testing protocols (e.g., cytotoxicity, irritation, sensitization).
• For shipping/distribution durability, the ground truth involved passing predefined physical durability and temperature tolerance limits.

8. Sample Size for the Training Set

• The document describes a 510(k) submission, which is for demonstrating substantial equivalence to a predicate device. It primarily focuses on verification and validation of the modified device's performance against the predicate.
• There is no mention of a separate "training set" in the context of device performance evaluation. The device itself is a mechanical instrument system, not an AI or algorithm that would require a labelled dataset for training.

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

Since there is no "training set" applicable to this type of medical device (which is a manual instrument system), this question is not applicable.

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The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty.

The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.

The Glenoid Intelligent Reusable Instrument System is composed of two (2) manual instruments intended for use to facilitate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. CT data and 3D modeling is used to provide preoperative planning of total shoulder glenoid component or reverse shoulder metaglene component orientation according to each patient's glenoid anatomy. The preoperatively planned and surgeon approved component orientation is subsequently transferred to the patient's glenoid during surgery by the use of a patient specific instrument and an adjustable instrument with patient specific settings. A patient specific Glenoid SmartBone - Pin Trajectory instrument is used to set the adjustable reusable instrument, the Glenoid Intelligent Reusable Instrument (Glenoid IRI), with the settings necessary to reflect the guide pin trajectory embedded in the Glenoid SmartBone. The Glenoid IRI is then used to guide the placement of the standard 2.5 mm pin (Steinmann pin) by the surgeon that is used in preparation of the glenoid for implantation of the glenoid component. All other steps of the surgical procedure are accomplished according to each system's standard surgical technique.

Here's a breakdown of the acceptance criteria and study information for the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the Glenoid IRIS. Instead, it describes a series of non-clinical tests performed to demonstrate "substantial equivalency" to predicate devices. The implicit acceptance criterion is that the device performs comparably to or within acceptable limits of the established performance of the predicate devices.

However, based on the non-clinical testing performed, we can infer the areas of performance evaluated:

Study Details

The provided 510(k) summary focuses on non-clinical testing for substantial equivalence, and explicitly states "Clinical testing was not necessary to determine substantial equivalence between the Glenoid IRIS and the predicate devices." Therefore, the following details pertain to the non-clinical studies.

1. Sample Size Used for the Test Set and Data Provenance:

   • Cadaver Study: The sample size is not specified in the document.
   • Sawbones Study: The sample size is not specified in the document.
   • Data Provenance: Not explicitly stated for both cadaver and sawbones studies, but typically for such non-clinical studies, they are conducted in a controlled lab environment, likely within the country of the manufacturer or a designated testing facility. The studies are by nature prospective for the device being evaluated.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • This information is not provided in the summary for the non-clinical studies. For cadaver and sawbones studies, "ground truth" would likely be established through precise measurements by trained personnel or independent confirmation of pin placement accuracy relative to the pre-operative plan, but the number and qualifications of these individuals are not detailed.

3. Adjudication Method for the Test Set:

   • This information is not provided in the summary. For non-clinical studies, "adjudication" in the sense of expert consensus on ambiguous cases is less common than for clinical image interpretation studies. Performance is typically assessed against a predefined measurement or technical standard.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states that clinical testing was not necessary. Such studies are typically clinical.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • The device is described as a "patient specific manual instrument system" that uses CT data and 3D modeling for preoperative planning. The software validation listed would likely assess the performance of the algorithm in generating accurate 3D models and planning outputs. However, the final "performance" of the system involves human interaction during surgery to use the instruments for guide pin placement. Therefore, a purely "standalone" algorithmic performance without human interaction regarding the surgical outcome itself is not fully applicable. The "software validation" line item indicates evaluation of the algorithmic component. Details of this validation are not provided.

6. Type of Ground Truth Used:

   • For the cadaver and sawbones studies, the ground truth would typically be established through precise anatomical measurements of the placed guide pin's trajectory and position relative to the pre-operative plan. This would involve highly accurate measurement tools and techniques.
   • For software validation, the ground truth would be based on known, correct 3D models and planning parameters, against which the software's output would be compared for accuracy and consistency.

7. Sample Size for the Training Set:

   • The document does not discuss a "training set" in the context of an AI/machine learning model needing to be trained on data. While the device utilizes "CT data and 3D modeling" for preoperative planning, it's presented as a tool, not necessarily an AI system that undergoes a separate training phase in the typical sense of deep learning. Therefore, a sample size for a training set is not applicable or not provided in this context. The 3D modeling likely relies on established anatomical algorithms rather than learning from a large dataset of prior cases.

8. How the Ground Truth for the Training Set Was Established:

   • As a "training set" for AI/ML is not explicitly mentioned or implied, this question is not applicable. The "ground truth" for the preoperative planning software would be derived from accurate anatomical representations and engineering specifications for component placement.

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