Search Results

The ARROW Off-Centred Humeral Insert is designed for the following indications: REVERSE PROSTHESIS (POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.

The provided document is a 510(k) summary for the ARROW Off-Centred Humeral Insert, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing and adherence to various ISO standards, rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).

Therefore, the document does not contain the specific information required to answer the questions about acceptance criteria and study proving device performance as typically applied to a diagnostic AI device or other devices requiring clinical performance metrics.

The document describes pre-market testing relevant to an orthopedic implant, such as:

• Mechanical performance testing: Connections between stem and humeral insert (ASTM F2009), Range of Motion for reverse prosthesis (ASTM F1378).
• Sterilization: ISO 11137
• Packaging: ISO 11607
• Biocompatibility: ISO 10993-1
• Bacterial Endotoxin: LAL validation

These tests are to demonstrate that the new device performs "as well as or better than the predicate devices" and "does not raise new questions about safety and effectiveness," fulfilling the criteria for substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert adjudication, or MRMC studies for a diagnostic or AI-driven device, as this information is not present in the provided text.

The provided text describes a physical medical implant, not a software-driven or AI-based diagnostic device. The "study" referenced in the text is mechanical performance testing and compliance with material, sterilization, and packaging standards, not a clinical study involving human readers or AI algorithm performance against ground truth.

If your intention was to ask about a different type of device or a different kind of performance study, please provide the relevant document.

Ask a specific question about this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193). The ARROW® Reverse porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.

This document is a 510(k) Premarket Notification from the FDA regarding the ARROW® Reverse Porous Glenoid. It is a submission for a Class II medical device (shoulder joint prosthesis) and primarily focuses on demonstrating substantial equivalence to existing predicate devices.

This document describes a medical device (shoulder prosthesis), NOT an AI/ML powered device.

Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

Here's a breakdown based on the provided document:

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

Since this is a submission for a physical medical device (shoulder prosthesis) and not an AI/ML powered device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to the results of engineering tests.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of prostheses tested) for the ASTM standards or LAL testing. These are typically engineering tests performed on a defined number of device units or material samples per the standard's requirements.
• Data Provenance: The tests were conducted by the manufacturer, Fournitures Hospitalières Industrie, based in France. The data would be "prospective" in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices or samples.

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

• Not Applicable. This is a physical device submission. "Ground truth" in the context of AI/ML models (e.g., expert annotation of medical images) is not relevant here. Device performance is assessed through standardized mechanical and biological tests. The "experts" would be the engineers and technicians performing and interpreting these standardized tests.

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

• Not Applicable. As above, adjudication methods common in AI/ML performance evaluation (e.g., for reconciling expert disagreements) are not pertinent to the mechanical testing of a medical implant.

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 not an AI-assisted device, so MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for AI/ML "ground truth". For a physical device, "ground truth" relates to established engineering principles and the specifications within the ASTM standards. The device is expected to perform in accordance with the established mechanical and material properties defined by these standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or "ground truth" establishment in the AI/ML sense.

In summary, this document is a regulatory submission for a traditional implantable medical device, demonstrating its substantial equivalence to previously cleared devices through adherence to established material and mechanical performance standards, rather than through AI/machine learning performance metrics.

Ask a specific question about this device

THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR:

• CENTRED GLENOHUMERAL OSTEOARTHRITIS -
• RHEUMATOID POLYARTHRITIS -
• POST-TRAUMATIC SEQUELA WITH GLENOID INJURY -
• -FRACTURES OF THE PROXIMAL HUMERUS WITH GLENOID INJURY
• REVISION FOR GLENOID LOOSENING -
• GLENOID BONE LOSS. WHERE BONE GRAFT IS NEEDED -
• A FUNCTIONAL ROTATOR CUFF IS NECESSARY TO USE THIS DEVICE

THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION

The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porous glenoid base is used with bone screws for fixation (cleared in K112193). The glenoid inserts and the porous glenoid bases are used in total anatomical prosthesis and are designed to articulate with the ARROW anatomical shoulder system (cleared in K093599).

The ARROW anatomical porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis namely: simple humeral prosthesis, total anatomical prosthesis (cemented glenoid implant with 4 pegs), total anatomical prosthesis (porous glenoid implant), pending, and reverse prosthesis.

The provided text is a 510(k) Summary for a medical device called "ARROW® ANATOMICAL POROUS GLENOID." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and performance testing, rather than reporting on a clinical study involving human subjects or AI-assisted diagnostic performance.

Therefore, the requested information regarding acceptance criteria and performance data from a study involving AI assistance or human-in-the-loop performance cannot be extracted from this document. The document describes mechanical performance testing, not clinical performance for diagnostic or treatment effectiveness in the way an AI diagnostic device would.

Here's what can be extracted based on the document:

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

The document states: "The ARROW anatomical porous glenoid was tested according to the ASTM F 1829 and ASTM F 2028 standards. After the tests were completed, it was determined that the ARROW anatomical porous glenoid performances were substantially equivalent to those of the selected predicate devices."

It does not provide specific numerical acceptance criteria or detailed results from these tests, only that the device met the standards and was "substantially equivalent."

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 document describes mechanical testing of a medical implant, not a clinical study involving a test set of data.

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. Ground truth for mechanical testing is established by engineering specifications and standard test methods (ASTM F 1829 and ASTM F 2028), not by expert human interpretation.

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

Not applicable, as this is not a diagnostic performance study requiring adjudication.

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 document does not describe any MRMC study or AI assistance.

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

Not applicable. This document pertains to a physical medical implant, not an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" would be established by the ASTM standards themselves and the physical properties of the materials and design, verified through laboratory measurements.

8. The sample size for the training set

Not applicable. This document describes mechanical performance testing, not the development of an AI algorithm.

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

Not applicable. There is no training set mentioned in this document.

Ask a specific question about this device