(183 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 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:
| Performance Area | Implicit Acceptance Criteria / Reported Performance |
|---|---|
| Verification and Validation | Device performs as intended and designed. (Details of specific performance metrics or thresholds are not provided in this summary.) |
| Biocompatibility and Toxicity | Meets ISO 10993-10 and USP Class VI standards. |
| Cadaver Study | Demonstrates safe and effective use in a cadaveric setting, confirming its ability to facilitate accurate guide pin placement. (Specific metrics not provided.) |
| Sawbones Study | Demonstrates safe and effective use in a sawbones model, confirming its ability to facilitate accurate guide pin placement. (Specific metrics not provided.) |
| Software Validation | Software components (for preoperative planning and 3D modeling) function correctly and reliably. (Specific metrics not provided.) |
| Packaging Integrity | Packaging maintains sterility and protects the device as required. (Specific metrics not provided.) |
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.”