Search Results

Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Software: Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

Ask a specific question about this device

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or; · a previously failed joint replacement and/or: · fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

The Delta Xtend Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws. The glenosphere and metaglene are used for total reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The provided document pertains to the 510(k) premarket notification for the DePuy Delta Xtend™ Reverse Shoulder System, specifically for the addition of lateralized glenosphere components. This document is a regulatory submission for a medical device (a shoulder prosthesis), NOT an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study proving device performance for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) is not applicable here.

The document discusses the substantial equivalence of the new components to predicate devices based on:

1. Biocompatibility: Confirmed per ISO10993-1.
2. Range of Motion: Theoretical simulated range of motion analyses showed an increase compared to the predicate non-lateralized glenosphere.
3. Glenoid Loosening/Disassociation: A study demonstrated substantial equivalency of glenoid fixation performance to the predicate.

The document explicitly states:

• "Summary of animal study: Animal study was not necessary."
• "Summary of clinical study: Clinical study was not necessary."

This indicates that clinical trials or studies that would involve human patient data, ground truth establishment by experts, or detailed statistical analysis of performance (as would be typical for AI/ML device validation) were not required for this specific 510(k) submission, as it focused on demonstrating substantial equivalence through non-clinical performance and design comparisons.

Therefore, I cannot extract the information required for an AI/ML device's acceptance criteria and study results from this document.

Ask a specific question about this device

The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.

The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.

The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:

• Uncoated,
• Hydroxylapatite (HAP) coated,
• HAP over titanium plasma spray (HAP/Ti PS) coated.

The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):

The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.

The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses:

• Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
• Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
• Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
• Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
  • Demonstration of design equivalence
  • Fatigue testing
  • Shear fatigue strength
  • Static shear strength per ASTM F1044
  • Static tensile strength per ASTM F1147
  • Abrasion resistance per ASTM F1978
  • Thickness per ASTM F1854
  • Mean void intercept length per ASTM F1854
  • Mean volume percent of void per ASTM F1854
• Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."

Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.

Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.

Here's why:

1. AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.

I can only extract information that is present in the document.

Ask a specific question about this device

The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059). The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be: Metaphysis, Stem Spacers, Stems, Assembly Screw, Securitization System: Securitization Bracket and Screw. The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599. The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty. The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options: Uncoated, Hydroxylapatite (HAP) coated, HAP over titanium plasma spray (HAP/Ti PS) coated. The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).

The provided document is a 510(k) premarket notification for a medical device (Aequalis Adjustable Reverse Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

The document discusses the substantial equivalence of this new device to previously marketed predicate devices based on material, design, sizing, indications for use, and non-clinical mechanical testing (e.g., fatigue, fretting corrosion). It's a regulatory submission for a physical orthopedic implant, not a software-driven diagnostic or prognostic tool.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance using the details from this document, as those types of studies and criteria are not applicable to the content provided.

Ask a specific question about this device