(163 days)
VIP Web Portal:
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.
OrthoVis Preoperative Plan:
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™ II and 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 shoulder 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.
The provided text contains a K241097 510(k) summary for the Arthrex Virtual Implant Positioning (VIP) System Software. It describes the device, its indications for use, and a summary of technological characteristics. However, it does not include detailed information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Specifically, the "Performance Data" section states: "Software verification and validation testing were conducted and Enhanced Level documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff 'Content of Premarket Submissions for Device Software Functions' dated June 14, 2023. Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing." This is a general statement about software testing but does not provide specific acceptance criteria or study results for device performance, especially in relation to human reader improvement with AI assistance, standalone algorithm performance, or details about the ground truth establishment.
Therefore, I cannot extract the requested information from the provided text.
Here's a breakdown of what the document does not include from your request:
- A table of acceptance criteria and the reported device performance: Not provided. The document mentions "software verification and validation testing" but no specific performance metrics or acceptance thresholds are listed.
- Sample sizes used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The device description focuses on planning software, not an AI to assist human readers in a diagnostic setting.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
- The type of ground truth used: Not explicitly stated for performance testing. For the planning software, the "ground truth" would likely be the accurate simulation/prediction of implant placement, which is established by comparing the software's output to engineering/anatomical specifications and possibly surgical outcomes, but this is not detailed.
- The sample size for the training set: Not applicable based on the information provided, as this is software for preoperative planning, not a machine learning model that typically involves a "training set" in the sense of clinical image analysis. The "OrthoVis desktop application" is where technicians create plans.
- How the ground truth for the training set was established: Not applicable for the reasons above. The "ground truth" for this type of software would be based on validated anatomical models and biomechanical principles used to develop the software's algorithms for implant positioning.
§ 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.”