(124 days)
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:
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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.
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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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: New materials must be biocompatible. | Passed: Cytotoxicity, intracutaneous irritation, and sensitization testing performed on steam-sterilized new photopolymer SmartBones. All tests passed. Stainless steel for IRI legs conforms to ISO 16061 and does not alter biocompatibility. |
| Shipping/Distribution Durability: Maintain integrity and functionality under temperature extremes and physical stress. | Passed: New SmartBone material with packaged SmartBones passed temperature extremes (140°F and -112°F for 120 hours) and drop testing. The predicate device was tested at 140°F and -20°F for 48 hours, implying the modified device met or exceeded these conditions. |
| Functional Equivalence: Performance in guiding glenoid guide pin placement must be equivalent to the predicate device. | Demonstrated Substantial Equivalence: In an artificial cadaver surgeon evaluation, the modified Glenoid IRIS was shown to be substantially equivalent in performance (mean version and inclination, and deviation from planned guide pin location) to the original Glenoid IRIS (K123122) for implanting a glenoid in a patient with severe glenoid retroversion. |
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.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”