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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.

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BePOD® 3A cannulated screws are designed for the following indications:

• Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.

• Compressive osteosynthsis of fractures of several bones in the forefoot.

BePOD® percutaneous cannulated screws are designed for the following indications:

• Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.

• Compressive osteosynthesis of fractures of several bones in the forefoot.

BePOD® Foot Screws includes the following elements: BePOD® 3A cannulated screws BePOD® percutaneous cannulated screws

The BePOD® Foot Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

This document is a 510(k) premarket notification for a medical device called "BePOD® Foot Screws." It aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as existing devices.

The information provided does not describe a study involving an AI/Machine Learning device or a diagnostic device, but rather a Class II surgical implant (bone screws). Therefore, the questions related to AI/ML device performance (like "acceptance criteria and reported device performance" for an AI/ML model, "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set") are not applicable to this document.

The document focuses on demonstrating substantial equivalence based on materials, sizes, design features, and intended use compared to predicate devices. It states:

• Device Description: BePOD® Foot Screws include BePOD® 3A cannulated screws and BePOD® percutaneous cannulated screws, intended for implantation using dedicated instrumentation.
• Indications for Use:
  • Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
  • Compressive osteosynthesis of fractures of several bones in the forefoot.
• Comparison of Technological Characteristics: The BePOD® Foot Screws and selected predicate devices (Auto® Fix Screws by SBI, BePOD® Cannulated Arthrodesis screws by FH Industrie, CALCANAIL Fracture by FH Industrie) share similarities in:
  • Materials used.
  • Available ranges of sizes.
  • Design features.
• Performance: The document states that the BePOD® Foot Screws are "identical in materials and size of the predicates selected." It also notes that "Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations."
• Substantial Equivalence: Claimed based on manufacturers' commercial documents and 510(k) submission information available on FDA's website for the predicate devices.
• Conclusion: The manufacturer believes the BePOD® Foot Screws are substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, and safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (bone screws) and does not contain the kind of performance study data that would be relevant to the questions posed, which are typically for diagnostic AI/ML medical devices.

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BePOD® EZ Weil screws are designed for the following indication:
-Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out:

• by the opened surgery (standard Weil) technique,
• by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).

The BePOD® EZ Weil Screws are threaded titanium screws which are self-drilling and selftapping designed for use in the foot. Once completely implanted, the screw is designed so the surgeon can snap off the introducer at the snap off axis.
The BePOD® EZ Weil Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

This document is a 510(k) premarket notification for a medical device called "BePOD® EZ Weil Screws." It describes the device's intended use and compares it to predicate devices to establish substantial equivalence for regulatory approval.

Based on the provided text, the device is a bone fixation fastener (specifically, screws for foot surgery). The document does not describe an AI/ML-based medical device or a study involving acceptance criteria for AI/ML performance, human readers, ground truth establishment, or training/test sets in the context of diagnostic or prognostic performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML device performance, as the document does not contain this information.

The document focuses on:

• Device Type: Metallic bone fixation screws.
• Indications for Use: Treatment of metatarsalgia on lateral metatarsal shafts by Weil osteosynthesis (open surgery or percutaneous technique).
• Substantial Equivalence: Comparison to legally marketed predicate devices based on materials, size ranges, and design features.
• Non-Clinical Testing: Mentions "Engineering Analysis" and "LAL pyrogen testing" but these are mechanical and biocompatibility tests, not performance studies as requested for AI/ML.

The "study" referenced in the document is a comparison for substantial equivalence, not a performance study as would be conducted for an AI/ML diagnostic or prognostic tool.

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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.

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Arthrodesis cannulated screws are designed for the following indication: Arthrodesis of the metatarsal-phalangeal joint of the big toe.

BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws. The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

This is a 510(k) premarket notification for a medical device, specifically the BePOD® Cannulated Arthrodesis Screws. Such notifications typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on a device's performance against specific acceptance criteria for AI algorithms.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document.

This document describes a traditional medical device (screws for bone fixation), not an AI/ML-driven device. The "Performance" section refers to material testing (LAL testing) and compliance with manufacturing regulations, not performance metrics based on data analysis or AI algorithms.

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ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for:

SIMPLE HUMERAL PROSTHESIS:

• Fracture dislocation or complex four part fracture of the proximal humerus
• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS):

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Fracture sequela, functional rotator cuff with glenoid injury.

REVERSE PROSTHESIS:
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 metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Humeral stems are composed of two stems size 6 and 16. These devices are designed to articulate with ARROW® anatomical shoulder system cleared in K093599 and ARROW® reverse shoulder system cleared in K112193.

ARROW® Humeral stems size 6 and 16 are intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193).

The provided document is a 510(k) premarket notification for the ARROW® Humeral stems size 6 and 16. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics for an AI/device would not be found in this type of regulatory submission.

However, I can extract the information that is present concerning performance and testing:

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

The document mentions that the general acceptance criteria for a 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved by showing similarities in:

• Intended use
• Indications for use
• Technological characteristics (materials, sizes, design features)
• Performance (mechanical tests)
• Safety and effectiveness

Regarding device performance, the document states:

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 submission references "mechanical tests" but does not detail the sample size or setup of these tests. This is a premarket notification for a medical implant, which typically relies on bench testing and comparison to predicate devices, not clinical trials with human subjects in the same way an AI/software device would.

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 to this document. The "ground truth" for this type of device is established through engineering and biomechanical standards, material specifications, and performance against established benchmarks for similar devices, not through expert consensus on interpretation or pathology of an image/data set.

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

This information is not applicable to this document. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic or predictive device performance.

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 to this document. MRMC studies are relevant for AI-powered diagnostic aids, not for physical medical implants like the ARROW® Humeral stems.

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

This information is not applicable to this document. This device is a physical implant; there is no "algorithm only" performance.

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

For this physical implant, the "ground truth" for performance is based on engineering and biomechanical standards, material specifications, and comparative mechanical testing against legally marketed predicate devices. The document implies compliance with Good Manufacturing Practices and quality assurance processes.

8. The sample size for the training set

This information is not applicable to this document. Training sets are relevant for AI/machine learning models, not for physical medical implants.

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

This information is not applicable to this document for the reasons stated above.

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The CalcaNail Orthopedic Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with:

• Comminuted fractures of the calcaneus
• Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
• Osteoarthritis of the posterior subtalar joint, or
• Valgus flatfoot deformities

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 12 mm nail available in 3 lengths (65 mm, 75 mm and 85 mm) for subtalar arthrodesis. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

This document is a 510(k) premarket notification for the CalcaNail Orthopedic Arthrodesis Nail, a medical device for subtalar arthrodesis. The information provided outlines the device, its intended use, and its comparison to predicate devices, but it does not contain acceptance criteria for device performance in the typical sense of a clinical trial or performance study on a new AI/software device. Instead, the "study" described is a biomechanical bench test and an engineering simulation comparing the CalcaNail to existing predicate devices for substantial equivalence.

Here's an analysis of the provided text based on your request, with the understanding that this is a hardware device submission, not an AI/software performance study. Therefore, many of your requested points related to AI/software performance metrics, ground truth, and expert evaluation are not directly applicable.

Acceptance Criteria and Device Performance (Based on presented data)

Since this is a hardware device submission and not a software/AI performance study, there aren't "acceptance criteria" in terms of sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to predicate devices through mechanical performance. The "reported device performance" refers to the results of the biomechanical and engineering tests.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria for substantial equivalence consists of two parts:

1. Biomechanical Bench Testing: This involved a direct comparison of the CalcaNail to a predicate device in terms of mechanical stability.
2. Engineering Simulation: This involved a comparison of rigidity between the CalcaNail and another predicate device using engineering principles.

Detailed Information for Each Point (as far as extract allows):

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

   • Biomechanical Testing: "Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones" were used.
   • Data Provenance: The origin of the human bones is not specified (e.g., country of origin). The study appears to be prospective (bench test designed for this submission), not retrospective clinical data.

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

   • This is not applicable as the "test set" consists of physical bones and engineering models, not data requiring expert interpretation for ground truth in the context of an AI/software device. The integrity of the bones and the setup of the biomechanical test would typically be managed by engineers and biomechanics experts, but these are not "ground truth experts" in the clinical sense.

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

   • Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical data annotation, which is not relevant for a biomechanical bench test or engineering simulation.

4. 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, a multi-reader multi-case comparative effectiveness study was not done. This is a hardware device, not an AI/software diagnostic tool.

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

   • No. This concept is for AI algorithms. The "standalone" performance here relates to the inherent mechanical properties of the nail itself.

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

   • For the biomechanical test, the "ground truth" is the measured mechanical stability of the construct under simulated loading conditions.
   • For the engineering simulation, the "ground truth" is the calculated moment of inertia and derived rigidity based on established engineering principles and material properties.
   • Neither of these involves clinical expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is a medical device (hardware) submission, not an AI/machine learning model where a "training set" would be used. The design of the nail is based on engineering principles and knowledge, not data training.

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

   • Not applicable, as there is no "training set" in the context of an AI/ML model for this hardware device. The device design is based on engineering and anatomical considerations.

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The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 10 mm nail available in 3 lengths (45 mm, 50 mm and 55 mm) for fracture repair. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

This document is a 510(k) Summary for a medical device called the "CalcaNail Orthopedic Nail." The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (a predicate device). Therefore, the information provided focuses on comparative performance rather than establishing absolute performance criteria for the new device in isolation.

Based on the provided information, the acceptance criteria and study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biomechanical Testing (Primary Stability):

  • Sample Size: Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones.
  • Data Provenance: The document does not explicitly state the country of origin. The test used human calcaneal and talar bones, implying ex vivo or cadaveric testing. The document states it's a "published testing," suggesting it was conducted retrospectively to the 510(k) submission, but the study itself could have involved prospective data collection on the cadaveric specimens.

• Engineering Simulation (Rigidity):

  • Sample Size: The smallest cross-sections of the CalcaNail nail and the FHI cannulated screws (K070617). The exact number of cross-sections or unique components modeled is not specified.
  • Data Provenance: This is an in silico (computer-based) study using engineering principles and likely based on design specifications of the devices. It is therefore retrospective in terms of the submission, but the data is generated via simulation.

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

• Biomechanics / Engineering: The document does not mention the use of human experts to establish "ground truth" for the biomechanical or engineering studies. These are objective measures (primary stability, moments of inertia) derived from physical testing and computational models, respectively, rather than subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. The studies described are objective measurements (biomechanical forces, rigidity calculations) rather than subjective assessments that would require 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 device is an orthopedic intramedullary nail, not an AI-powered diagnostic imaging tool, so such a study would not be relevant.

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

• Not applicable. This is a physical, implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Biomechanical Testing: The "ground truth" here is the objective, measured mechanical performance (primary stability) obtained from physical testing on human cadaveric bones.
• Engineering Simulation: The "ground truth" here is the mathematically calculated and simulated rigidity (moments of inertia) based on the physical properties and geometries of the devices.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, this device does not involve a training set or ground truth establishment in the context of machine learning.

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The ARROW® Reverse Shoulder long keel and short keel glenoid base 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 metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Reverse Shoulder long keel and short keel glenoid base consist of a metal-back glenoid base, used with bone screws for fixation and assembled with previously cleared glenosphere. These components are used in total reverse prosthesis and are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193.

The bone fixation screws are cleared in K112193.

The ARROW® Reverse Shoulder long keel and short keel glenoid base is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193)).

The provided document is a 510(k) premarket notification for a medical device (ARROW® Reverse Shoulder long keel and short keel glenoid base) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel device or software. Therefore, much of the requested information regarding acceptance criteria, specific study designs, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or diagnostic devices, is not directly applicable or available from this type of regulatory submission.

However, I can extract the information that is present and explain why other aspects are not applicable.

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

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values in the way one would typically expect for a diagnostic or AI-driven device. Instead, the "performance" is assessed through a cyclic mechanical protocol to demonstrate substantial equivalence to predicate devices.

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

The "test set" for this device refers to the physical devices subjected to mechanical testing. The document does not specify the exact sample size (number of devices or components tested) used for the cyclic mechanical protocol.

Regarding data provenance, the testing was performed by the manufacturer, Fournitures Hospitalières Industrie, in France. The document does not specify if different batches or manufacturing runs were tested, nor does it refer to "countries of origin" for data in the context of clinical populations, as this is a mechanical testing scenario for an orthopedic implant.

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

This question is not applicable to this type of device and study. For a mechanical device like a shoulder implant component, "ground truth" is not established by human experts in the diagnostic sense. The "ground truth" for mechanical performance is typically defined by engineering specifications, material properties, and validated testing methods (e.g., ISO standards, ASTM standards) that simulate in-vivo conditions. The evaluation of whether the mechanical tests were performed correctly and meet the implicit equivalence criteria would be done by engineers and regulatory reviewers, not medical experts establishing a diagnostic ground truth.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in diagnostic imaging cases, especially when there's inter-reader variability. For mechanical testing of a medical device, the results are typically quantitative and objective measurements (e.g., strength, fatigue life). The "adjudication" (if one could even call it that) of the test results themselves would be against predefined engineering acceptance criteria, potentially verified by internal quality control or external testing labs, not by a panel of experts.

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 question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers (e.g., radiologists). The ARROW® Reverse Shoulder long keel and short keel glenoid base is an orthopedic implant (a physical device), not a diagnostic tool or an AI-assisted system.

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

This question is not applicable. This device is a physical implant, not an algorithm or software. Therefore, there is no "standalone algorithm only" performance to evaluate.

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

The document does not describe "ground truth" in terms of clinical or diagnostic data. For the mechanical testing, the "ground truth" is effectively the performance of the predicate devices and generally accepted mechanical engineering principles and standards for orthopedic implants under simulated physiological loads. The goal was to show that the new device's mechanical performance was "substantially equivalent" to these established benchmarks.

8. The sample size for the training set

This question is not applicable. As this is a physical medical device (an implant), there is no "training set" in the context of an AI algorithm or a statistical model derived from a dataset.

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

This question is not applicable (see response to #8).

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The CoLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

The CoLS® Fixation System is composed of the following elements: The CoLS® tendon anchoring screw, implantable device, used for the fixation of the CoLS® tendon anchoring tape to the bone. The CoLS® tendon anchoring tape, it is a non absorbable surgical suture, used for the ACL and PCL reconstruction, to which the tendon graft is attached. This implantable tendon anchoring tape is used with accessories non implantable: tape support, passing wire and scalpel blade. The CoLS® Fixation System is provided sterile and it is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

Here's an analysis of the provided text regarding the CoLS® Fixation System, focusing on acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described is a comparison of characteristics and performance rather than a full efficacy clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a dedicated clinical or pre-clinical study with specific sample sizes for tensile strength or biocompatibility. Instead, the "tests were performed" to compare the new device to the predicate. This suggests laboratory testing rather than a patient-based test set.

• Sample Size: Not explicitly stated. The document refers to "tests were performed" but does not give the number of samples used for tensile strength or biocompatibility testing.
• Data Provenance: The tests were performed as part of a 510(k) submission from Fournitures Hospitalières Industrie, a French company. The nature of the tests (tensile strength, biocompatibility) implies laboratory testing, which is generally retrospective in the sense that the device has already been designed and manufactured when these comparative tests are conducted.

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

This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence here relies on direct comparative testing of physical characteristics (tensile strength, biocompatibility, material, design, etc.) against a legally marketed predicate device, rather than expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of ambiguous cases or outcomes, such as in diagnostic imaging or clinical trials. The described "tests" are laboratory-based comparisons of physical and material properties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, usually in diagnostic scenarios. This 510(k) is for a physical medical device (fixation system) and does not involve AI or human interpretation of outputs.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This 510(k) is for a physical medical device and does not involve a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for this substantial equivalence determination is established by:

• Comparative Laboratory Testing Data: Tensile strength and biocompatibility data from the novel device were compared directly to the predicate device.
• Direct Comparison of Device Characteristics: Material composition, design, operating principle, sterilization method, and indications for use were directly compared to the predicate device.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense used for diagnostic or treatment efficacy studies, as the core of this submission is device equivalence based on physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for an AI/ML model.

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