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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 nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• · Post-traumatic arthritis

Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

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. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts was used.

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 mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

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When used in the Humelock II Reversible Shoulder System: The Humelock II Reversible Shoulder 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

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

When used in the Humelock Reversed Shoulder System:

The Humelock Reversed Shoulder 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.

The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cemented stems.

The clenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

When used in the Humeris Shoulder System:

In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis: -

Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision . of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.

This FDA 510(k) summary describes a device, "Lateralized and Augmented Baseplates," that is a modification of existing shoulder prosthesis components. The review focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the new components.

Therefore, the information provided does not fully answer all sections of your request regarding detailed acceptance criteria and a study proving those criteria are met for the new device. However, I can extract the relevant information about the non-clinical testing performed and the general approach to demonstrating equivalence.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with specific thresholds for the new Lateralized and Augmented Baseplates. Instead, it refers to prior bench testing conducted for the predicate devices and states that new non-clinical testing for the subject device met acceptance criteria based on those established standards.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the Range of Motion or Glenoid Loosening tests for the new Lateralized and Augmented Baseplates. It refers to "all samples" for the glenoid loosening test without specifying the number.
The data provenance is not explicitly mentioned as country of origin, but the manufacturer is FX Solutions in Viriat, France. The studies are non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device assessment relies on established engineering standards (ASTM F-1378-18, ASTM F2028) for non-clinical bench testing, not expert-derived ground truth.

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

Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessment. This involved objective measurements against engineering standards.

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 device (implant), not an AI/software device that would involve human readers or image interpretation.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for non-clinical testing of the Lateralized and Augmented Baseplates was adherence to established engineering standards (ASTM F-1378-18 for Range of Motion and ASTM F2028 for Glenoid Loosening).

8. The sample size for the training set

Not applicable. This device does not involve a training set in the context of AI or machine learning. Its design and performance are based on engineering principles and testing.

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

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria referred to in this 510(k) is a set of non-clinical bench tests. These tests were performed to demonstrate that the Lateralized and Augmented Baseplates, which are design modifications of previously cleared components, perform similarly to their predicates and meet relevant ASTM standards for mechanical performance.

• Range of Motion (ROM) Analysis: This analysis was conducted based on the same parameters and assumptions as previously submitted ROM analyses for the primary predicate devices. It concluded that the subject device demonstrated substantial equivalence in ROM and "exceeding ASTM F-1378-18."
• Glenoid Loosening Test: Performed according to ASTM F2028. The report states that "all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate," indicating the device met the acceptance criteria for this standard.

The FDA concluded that "Clinical testing was not necessary to determine substantial equivalence of the Lateralized and Augmented Baseplates to the predicate devices," based on the non-clinical testing and assessment of other factors like materials, manufacturing, and indications for use. This means the non-clinical tests were deemed sufficient to support the substantial equivalence claim.

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The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was a non-clinical study based on engineering performance tests.

4. Adjudication Method for Test Set

Not applicable. There was no test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.

7. Type of Ground Truth Used

The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.

8. Sample Size for Training Set

Not applicable. This was a non-clinical study for a physical device, not an AI model.

9. How Ground Truth for Training Set Was Established

Not applicable. There was no training set in the context of this device.

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