(83 days)
The VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.
The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid), Univers Revers™ modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines.
The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
Arthrex Virtual Implant Positioning (VIP) System software comprises VIP Web Portal software and OrthoVis Preoperative Plan software. The VIP Web Portal is web-based software intended for use to facilitate the upload of medical images, preoperative planning, and plan approval of placement and orientation of total joint replacement components. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the VIP Web Portal by Arthrex technicians and used to create preoperative plans in OrthoVis (a desktop application). Once created, the preoperative plans are uploaded back to the VIP Web Portal, where the surgeon user is then able to login and review the preoperative plan. Subsequently, the surgeon user may either approve the plan, or modify the type, size, location and/or orientation of the joint replacement component and then approve the plan. The approved plan is then made available for download by the surgeon user.
This document, being a 510(k) Summary from the FDA for a medical device (K230904: Arthrex Virtual Implant Positioning (VIP) System), primarily focuses on demonstrating substantial equivalence to a predicate device. While it mentions software verification and validation, it does not contain the specific details of acceptance criteria for performance, nor a detailed study proving the device meets those criteria, as one would typically find in a clinical or performance study report.
The information provided largely outlines the device's purpose, indications for use, and a summary of technological characteristics compared to predicates. It confirms that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" It also states that "Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing." However, these are general statements about development and testing processes, not detailed performance study results against specific acceptance criteria.
Therefore, many of the requested items cannot be definitively extracted from the provided text. The document describes that performance testing was done, but not what the acceptance criteria were or the results of those tests in a quantifiable manner as you've requested.
Here's an attempt to answer based on the absence of information and what can be inferred:
Acceptance Criteria and Study for Arthrex Virtual Implant Positioning (VIP) System (K230904)
Based on the provided 510(k) Summary, specific quantitative acceptance criteria for device performance and the detailed results of a study proving those criteria are not explicitly stated or provided in this document. The summary indicates that software verification and validation testing were conducted according to FDA guidance, which generally implies functional, performance, and safety testing. However, it does not disclose the specific metrics or thresholds used for acceptance, nor the results achieved.
What can be inferred or stated as "not provided":
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The general statement about "Software verification and validation testing were conducted" does not include a table of specific performance metrics (e.g., accuracy of implant positioning, measurement precision) with defined acceptance criteria and corresponding reported performance values.
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Sample Size Used for the Test Set and Data Provenance: This information is not provided. The document mentions general validation and verification activities but no details about the size or nature of any test sets (e.g., number of patient cases, images) or their provenance (country of origin, retrospective/prospective).
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Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. The document does not describe the establishment of ground truth for any performance testing, nor does it mention the involvement or qualifications of experts for this purpose.
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Adjudication Method for the Test Set: This information is not provided. Given that details on ground truth establishment are absent, the adjudication method is also not mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This information is not provided. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it mention any effect sizes related to such a study. The device is a "preoperative planning software" primarily for displaying/editing implant placement, suggesting its role might be more about facilitating existing workflows rather than direct "AI assistance" in diagnosis requiring an MRMC study. However, the details are unclear.
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Standalone (Algorithm Only) Performance: This information is not provided in terms of specific metrics and results. The emphasis is on the software supporting a workflow ("displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians"). While software verification/validation would include testing the algorithm's functionality, the document does not present quantitative standalone performance figures (e.g., accuracy of automated segmentation if applicable, though it notes "segmentation is automated (but manually verified)").
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Type of Ground Truth Used: This information is not provided. There is no mention of whether ground truth was based on expert consensus, pathology, surgical outcomes, or another method.
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Sample Size for the Training Set: This information is not provided. No details about a training set for any machine learning components are mentioned.
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How the Ground Truth for the Training Set Was Established: This information is not provided. As no training set details are given, how its ground truth was established is also not discussed.
Conclusion from the Document:
The 510(k) Summary serves to demonstrate "substantial equivalence" of the Arthrex Virtual Implant Positioning (VIP) System to a predicate device, specifically for expanded indications related to humeral components. It states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance." This implies that the necessary internal testing and documentation were completed to satisfy regulatory requirements for demonstrating functional capabilities and safety, but the specifics of those tests, including quantitative acceptance criteria and results, are not detailed in this public summary document. For such detailed performance data, one would typically need to consult a more comprehensive clinical or performance study report, which is not part of this 510(k) summary.
§ 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.”