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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.

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The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

The Humelock II Reversible Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without a stabilization screw, 135/145° humeral cups, standard humeral cups and a 135/145° adaptor. These components are intended for use with the previously cleared Humelock II Cemented Humeral Stems and the Humelock II Cementless Humeral Stems. The design of the Humelock II Reversible Shoulder allows conversion from an anatomic shoulder configuration to a reverse shoulder configuration either intraoperatively or during revision of an anatomic shoulder with a well fixed humeral stem.

The glenoid baseplate, standard and locking screws, baseplate post extensions, glenosphere screws and 135/145° reverse adapters are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxylapatite coating. The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The 135/145° Humeral Cups and standard Humeral Cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2.

Based on the provided text, the device described is the Humelock II Reversible Shoulder System, which is a medical implant, not an AI/software device. Therefore, the questions related to acceptance criteria, study design for AI devices, and performance metrics for AI models are not applicable to this document.

The document is a 510(k) premarket notification summary for a medical device (a shoulder prosthesis), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

However, I can extract information related to the physical device's "performance" as described in the "Non-Clinical Testing" section, which might be interpreted as "acceptance criteria" for a medical implant, and then address why other points are not applicable.

Here's a breakdown of the requested information based on the provided text, indicating where it's not applicable to this medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/Software specific questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a physical medical implant device, not an AI/software product, so there is no "test set" in the context of AI model evaluation. The "tests" mentioned are non-clinical biomechanical and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a physical medical implant device. Ground truth, in the AI context of expert consensus, is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering standards and biomechanical principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there's no "test set" for an AI model, adjudication methods are irrelevant.

5. 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 Applicable. This is a physical medical implant device. MRMC studies are for evaluating diagnostic performance with or without AI assistance, which doesn't apply to a shoulder prosthesis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical implant device. There is no algorithm or standalone AI performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable in the AI context. For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and biomechanical stability benchmarks typically verified through laboratory testing against established standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical implant device. There is no AI training set.

9. How the ground truth for the training set was established

• Not Applicable. This is a physical medical implant device. There is no AI training set.

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