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When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. 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).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

TiN coated Heads are not intended for hemi-shoulder arthroplasty

When used with 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 joint 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).

TiN coated Heads are not intended for hemi-shoulder arthroplasty.

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 and structurally 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 TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.

This document is a 510(k) Premarket Notification from the FDA regarding a TiN Coated Humeral Head. It does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, training set details) because this document does not pertain to an AI/ML medical device and does not contain information about a study proving an algorithm's performance.

The document states:

• "Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head to the predicate devices." (Page 7)
• The determination is based on the device being "identical to the primary predicate with the only modification of added TiN coating" and a review of "risk analysis, design controls, biocompatibility, wear properties of the TiN coating, and verification and validation activities to demonstrate that the TiN coating does not increase risk and does not raise new questions of safety and effectiveness." (Page 7)

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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 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 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 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 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 hemishoulder prosthesis.

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

The glenoid 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 joint resulting from osteoarthritis or rheumatoid arthritis; - Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.q. 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 and structurally 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 Humelock TiN Coated Glenosphere is a new component for Humelock II, Humelock Reversed, and Humeris reversed total shoulder replacement systems. The Humelock TiN Coated Glenosphere has a titanium nitride (TiN) coating, which is applied to the predicate glenosphere made of cobalt chromium molybdenum (CoCr). Compatible components for use with the Humelock TiN Coated Glenosphere to complete the reversed total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr glenospheres in the primary predicate device, K150488 and are also components in K162455 for the Humelock Reversed Shoulder System and K163669 for the Humeris Shoulder, when used for a reverse shoulder construct.

This document describes the Humelock TiN Coated Glenosphere, a new component for shoulder replacement systems. Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests. The document mentions "wear testing" and "biocompatibility testing" but doesn't provide the number of devices or samples used for these non-clinical tests.
• Data Provenance: All testing mentioned is non-clinical (e.g., in-vitro, material characterization, animal studies). There is no patient data involved in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This is not applicable as the evaluation relies solely on non-clinical testing and substantial equivalence to previously cleared devices and a reference device. There are no "ground truth" labels established by human experts on a clinical test set.

4. Adjudication Method for the Test Set

• This is not applicable as there is no clinical test set requiring human 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

• No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (implant component) and does not involve AI or human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is established through objective scientific methods and standards for material characterization, mechanical testing, and biocompatibility, as well as the established safety and effectiveness profiles of the predicate and reference devices. For instance, biocompatibility is evaluated against ISO standards, and mechanical wear is measured.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as there is no training set.

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The LINK® TrabecuLink® Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction.

The LINK® TrabecuLink® Tibial Cones are indicated for the following conditions:

· Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata or other pathologies.

The device is intended for uncemented use.

The LINK® TrabecuLink® Tibial Cones are designed to be used in conjunction with the LINK® Endo-Model® Knee System Standard / Modular / Porex® coated (K143179; K152431) and with the Endo- Model® SL® Knee System (K151008) tibial components. The subject device is intended to fill small to medium bone defects and provide a stable platform for the tibial articulating components.
The tibial cones are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ISO 5832-3). The tibial cones consist of a non-porous bulk interior surface and a trabecular structure made of titanium (LINK® TrabecuLink®) on the external surface.
The LINK® TrabecuLink® Tibial Cones provide cementless fixation to the bone. The subsequently implanted knee endoprosthesis is cemented to the tibial cone.

This document describes the LINK® TrabecuLink® Tibial Cones, a medical device used in total knee replacement surgeries. It does not describe an AI/ML device, and therefore, the information typically requested about AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training sets) is not applicable here.

The document focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and 510(k) summary do not present formal "acceptance criteria" for performance in a table format with specific numerical targets. Instead, they refer to "non-clinical performance testing and analysis" which demonstrate that the device is "as safe, as effective and substantially equivalent to the predicate device." The "acceptance" is implicitly that the device performs comparably to the predicate devices in these tests.

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

• Test Set Sample Size: Not applicable. This refers to non-clinical bench testing, not a dataset of patient cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was 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, as this was non-clinical bench testing. Performance was assessed against engineering and material science standards and comparison to predicate devices, not expert human interpretation.

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

• Not applicable, as this was non-clinical bench testing.

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/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

• For non-clinical performance, the "ground truth" or reference for assessment would be established engineering and material science standards, specifications, and direct comparison to the performance characteristics of the predicate devices. There is no biological "ground truth" (like pathology or outcomes data) established for these specific tests, as they are mechanical and material characterizations.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and no training set was used.

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

• Not applicable. This is not an AI/ML device.

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The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:

• Degenerative, post-traumatic or rheumatoid arthritis;
• Avascular necrosis of the femoral condyle;
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
• Moderate valgus, varus or flexion deformities.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

The LINK® GEMINI® SL® Total Knee System is a semi-constrained, patellofemorotibial, cemented knee prosthesis. It is intended to replace the three articular portions of the knee joint. The system compromises two different designs: “Cruciate Retaining (CR) tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification.

This document is a 510(k) premarket notification for the LINK® GEMINI® SL® Total Knee System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria that the device proves to meet in a clinical setting.

Therefore, the information you requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial with performance metrics, is largely not applicable in this document. This submission relies on non-clinical performance testing to demonstrate substantial equivalence.

I will address the requested points based on the information provided, explicitly stating when the information is not available or not applicable.

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

This document does not specify "acceptance criteria" in the format of pass/fail metrics for a clinical study. Instead, it relies on demonstrating that the device performs comparably to the predicate device through non-clinical testing. The "reported device performance" is the successful completion of these non-clinical tests.

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

This information is not provided in the document. The document refers to "non-clinical performance testing," which typically involves laboratory testing on device components, not human test subjects or retrospective/prospective data from a specific country. Therefore, "sample size for the test set" and "data provenance" as applied to clinical studies are not relevant here.

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)

This information is not applicable as there was no clinical test set requiring expert ground truth. The evaluation was based on non-clinical engineering and materials testing.

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

This information is not applicable as there was no clinical test set or human interpretation 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

This information is not applicable. The device is a total knee system, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned or performed.

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

This information is not applicable. The device is a total knee system, not an algorithm or AI system.

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

The "ground truth" in this context is the established scientific and engineering principles and standards (e.g., ISO and ASTM standards) for evaluating the mechanical and material performance of total knee prostheses. The device's performance was compared against these standards and the known performance of the predicate device.

8. The sample size for the training set

This information is not applicable as the document describes a medical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the reasons stated in point 8.

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The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women.

The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection.

The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

Not Found

This is a letter for the ARIES GBS Assay from the FDA and does not contain the information required to answer the question, as it is a device approval letter and not a study.

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