(106 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
The SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K151500) to be set according to prescribed lengths and heights for a specific patient's glenoid anatomy. The IRI leg lengths and their respective heights are determined in the OrthoVis software which is a part of the Arthrex Glenoid IRIS system. Along with the IRI leg lengths for each IRI slot and their respective heights, images of where the IRI was planned to sit on the patient's glenoid for the prescribed leg lengths and heights are given.
Loading the IRI device according to the prescribed lengths, setting the height of each IRI leg according to the prescribed SmartBase ruler heights, and then placing the IRI on the glenoid according to the preoperative plan images allows the IRI to transfer the guide pin for the surgeon-approved, preoperatively-planned glenoid implant trajectory to the patient in the OR. It provides the same function as the SmartBone (setting the IRI device), which was previously cleared in the predicate, K151500.
The document describes the SmartBase for Arthrex Glenoid IRIS, a reusable instrument intended to facilitate the intraoperative placement of the central glenoid guide pin during total shoulder replacement surgery. The device is a "patient-specific manual instrument system" designed to interface with the Arthrex Glenoid IRIS system.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy of Glenoid Guide Pin Placement | No significant difference compared to the predicate device (SmartBone). | "Results of the SmartBase vs. SmartBone study found that there is no significant difference between using the SmartBase or the SmartBone-Pin Trajectory instrument in placing the glenoid guide pin." |
| Accuracy of IRI Leg Height Achievement | No significant error in achieving planned IRI leg heights. | "Results also found that there was no significant error in achieving the planned IRI leg heights with the SmartBase device." |
| Biocompatibility | Conformance with ISO 16061 and FDA Guidance for common biocompatible materials. | The SmartBase device's indirectly patient-contacting parts (316 stainless steel) are composed of a commonly used biocompatible alloy, conforming to ISO 16061 and FDA guidance, thus no further biocompatibility testing was required. |
| Sterilization/Cleaning Efficacy | Validated for cleaning and sterilization in the modified Arthrex Glenoid IRIS tray. | "Cleaning and Sterilization Validation was performed on the SmartBase device in a fully loaded Arthrex Glenoid IRIS Instrument tray." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions a "SmartBase vs. SmartBone Comparison Study." However, it does not specify the sample size used for this test set (e.g., number of cases, number of measurements).
The document also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for this comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the comparison study. Given the nature of comparing instrument performance in placing a guide pin, the "ground truth" likely referred to the preoperatively planned pin trajectory or a direct measurement of the achieved pin trajectory relative to the plan, rather than a diagnostic interpretation by experts.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No, an MRMC comparative effectiveness study was not done. This device is a manual surgical instrument, not an AI or imaging diagnostic device. The study focused on comparing the performance of two physical instruments (SmartBase vs. SmartBone).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm-only) performance study was not done. The SmartBase is a manual instrument used by a surgeon, and its performance is inherently tied to human interaction.
7. The Type of Ground Truth Used
The "ground truth" in the "SmartBase vs. SmartBone Comparison Study" appears to be defined by the preoperatively planned glenoid guide pin trajectory and the planned IRI leg heights. The comparison aimed to determine if the SmartBase could achieve these planned parameters as effectively as the predicate SmartBone. This is essentially a metrological or accuracy-based ground truth related to surgical planning and execution.
8. The Sample Size for the Training Set
The document does not mention a training set. This is because the device is a mechanical instrument, not an AI algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.”