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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular Labral Repair and Reconstruction

The fundamental technology of the Arthrex FiberTak Suture Anchors is that the Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The subject device is FiberTak Anchor with 1.3 mm SutureTape (White/Blue) and is a knotted FiberTak with a Polyester Sheath and a Polyester/UHMWPE repair suture.

The subject device is preloaded on a disposable inserter, which facilities deployment. The subject anchor and connected sutures are impacted into a pilot hole. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The device is provided sterile and is intended for single-use.

The provided FDA 510(k) Clearance Letter concerns a physical medical device (suture anchor) and not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI acceptance criteria, training sets, ground truth establishment by experts, MRMC studies, and stand-alone algorithm performance are not applicable to this document.

The clearance for the Arthrex FiberTak Suture Anchor is based on substantial equivalence to existing predicate devices, primarily demonstrated through performance testing rather than clinical study data from image analysis or diagnostic tasks.

Here's an analysis of the provided text based on the nature of the device:

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

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

• Sample Size: Not specified in the provided text. The document states "Straight Pull testing... was conducted." For mechanical testing, the "sample size" would refer to the number of anchors tested, which is typically outlined in the test report referenced (ASTM F3690).
• Data Provenance: Not specified. It's likely that the testing was performed in a lab setting (in vitro) to regulatory standards (ASTM F3690). This is not retrospective or prospective clinical data.

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 clearance based on mechanical testing and substantial equivalence, not on diagnostic accuracy established by expert consensus. There is no "ground truth" established by experts in the context of image interpretation or diagnosis.

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

• Not Applicable. As per point 3, there is no expert panel or image interpretation data 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:

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• The "ground truth" in this context refers to the objective mechanical performance characteristics of the device (e.g., force at failure, displacement) as measured by standardized engineering tests (e.g., ASTM F3690). The "truth" is derived from these empirical measurements, not expert interpretation of clinical data.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" or "ground truth" in the context of machine learning for this device.

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The Arthrex PushLock Suture Anchors (2.9 - 4.5 mm) are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair (2.9 x 15.5 - 24 mm only), acetabular labral repair.

The Arthrex PushLock Suture Anchors (2.5 mm) are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex Short Suture Anchors (2.0 - 2.4 mm) are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

The Arthrex Self-Punching PushLock Suture Anchors (3.5 mm) are intended to be used for suture (soft tissue) fixation to bone in the shoulder:

Shoulder: Rotator Cuff Repair

The Arthrex PushLock Suture Anchor is a two piece "push-in" suture anchor device comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchors are threaded and range from 2.0 mm to 4.5 mm in diameter and 8.6 mm to approximately 24 mm in length. The device is sold sterile and is single-use.

The Arthrex Self-Punching PushLock Suture Anchor is a "push-in" suture anchor comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body is fully threaded and barbed. The anchor is 3.5 mm in diameter and 19.8 mm in length. The device is sold sterile and is single-use.

The provided FDA 510(k) clearance letter describes a medical device, the Arthrex PushLock Suture Anchors, and its substantial equivalence to predicate devices, rather than a study proving the device meets performance criteria for an AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/CADe system cannot be extracted directly from this document.

However, I can extract information related to the device itself and the types of performance testing conducted to demonstrate its safety and effectiveness relative to its predicates.

Here's a breakdown of the available information based on your request, with an emphasis on what can be extracted and what cannot from this specific document:

Device Name: Arthrex PushLock Suture Anchors
K Number: K251145

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

This document does not specify quantitative acceptance criteria or detailed reported performance values for an AI/CADe system. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a physical orthopedic implant. The performance data mentioned are general categories of testing for such devices.

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 510(k) clearance letter. The document mentions "product functionality... sterilization validation, biological safety evaluation and temperature study testing," but does not detail the sample sizes for these tests, nor their provenance in terms of patient data. These tests are typically conducted on the physical device itself or its materials, not on clinical datasets in the way an AI/CADe study would use.

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 and not provided. This clearance is for a physical medical device (suture anchor), not an AI/CADe system that requires expert interpretation for ground truth establishment.

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

This information is not applicable and not provided for the reasons stated above.

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 and not provided. An MRMC study is relevant to AI/CADe systems, not a physical implant like a suture anchor.

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

This information is not applicable and not provided.

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

This information is not applicable in the context of an AI/CADe device's ground truth. For the Arthrex PushLock Suture Anchors, "ground truth" would relate to its physical properties, biocompatibility, and mechanical performance, which are evaluated through standardized test methods (e.g., ASTM standards) rather than expert consensus on clinical data or pathology reports. The document mentions "product functionality," "biological safety evaluation," and "sterilization validation," implying the use of established scientific and engineering principles for evaluation.

8. The sample size for the training set

This information is not applicable and not provided. There is no AI/CADe system being trained with clinical data.

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

This information is not applicable and not provided.

Summary of what the document does convey about the study (testing) conducted:

The submission aimed to obtain FDA clearance for the Arthrex PushLock Suture Anchors, sterilized using the Arthrex X-ray radiation sterilization process. The core of the "study" for this type of device is demonstrating substantial equivalence to existing legally marketed predicate devices.

The performance data supplied consisted of:

• Product functionality (including accelerated aging)
• Product induced radiation
• Sterilization validation
• Biological safety evaluation
• Temperature study testing

These tests compared the subject device to several predicate and reference devices, confirming that the new device, particularly with its new sterilization process, performs equivalently in terms of safety and effectiveness. The conclusion states that "Any differences between the Arthrex PushLock Suture Anchors and the predicate devices are considered minor and do not raise different questions of safety or effectiveness."

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The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:

• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.

The iBalance BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

These components are single use only and are intended for implantation with bone cement.

The Arthrex iBalance Partial Knee System encompass the following FDA cleared devices:

• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System

These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis.

The provided FDA 510(k) clearance letter for the Arthrex iBalance Partial Knee System does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

This document is a clearance letter for a physical medical device (a knee replacement system), not an AI-powered diagnostic or treatment algorithm. The "performance data" mentioned refers to non-clinical and in-vivo electromagnetic simulation related to the device's "MR Conditional" status, which is about its safety in an MRI environment, not its diagnostic or therapeutic accuracy as an AI would have.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, expert consensus, MRMC studies, etc.) from this document because it is not relevant to an AI/algorithm-based device study.

To provide the information you're looking for, I would need a 510(k) clearance letter or a clinical study report specifically detailing the performance evaluation of an AI/algorithm-based medical device.

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The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues.

The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

This document is a 510(k) clearance letter for a medical device called "SuturePatch Tissue Reinforcement." It does NOT describe an AI/ML device or its acceptance criteria and a study proving it meets them. The text provided is wholly unrelated to AI/ML.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical surgical mesh and details its regulatory clearance, not the performance of an AI/ML algorithm.

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The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).

The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.

The provided FDA approval letter heavily focuses on the regulatory and administrative aspects of the device, primarily confirming its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about a study proving specific acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance (MRMC), or detailed clinical trial information.

The document discusses the mechanical performance of the Arthrex Spine Compression FT Screw, which is a physical medical device (a screw for spinal fixation), not a software or AI-driven diagnostic tool. Therefore, many of the requested points (e.g., sample size for test set, ground truth for test set, number of experts, MRMC study, standalone algorithm performance, training set details) are not applicable to the type of device described in this FDA letter.

However, based on the information provided, I can infer and state what is available regarding the device's performance demonstration:

Device: Arthrex Spine Compression FT Screw

Purpose of Submission: To obtain clearance for the Arthrex Spine Compression FT Screws for spine indications, demonstrating substantial equivalence to predicate devices.

Type of Device: A physical, implantable medical device (a screw for spinal fixation), not an AI/software diagnostic tool.

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a physical device, the "acceptance criteria" discussed are related to its mechanical performance and safety for implantation and MR compatibility, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for mechanical or MR compatibility testing. These are typically bench tests following established standards, not patient-based test sets.
• Data Provenance: The studies are described as "non-clinical testing" conducted by Arthrex. This implies in-house laboratory testing. Not applicable to country of origin, retrospective/prospective data as these are not clinical trials.

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

• Not applicable. The "ground truth" for mechanical and MR compatibility tests is defined by the test standards (e.g., ASTM F2193, F2182-19, F2119-13) and physical measurements, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation, not for bench testing of mechanical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is designed to assess human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is a surgical implant, not a diagnostic AI tool.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• For mechanical testing: Engineering specifications and direct physical measurements according to validated test methods (ASTM standards).
• For MR compatibility: Measurements against established safety limits and comparisons to predicate devices, verified through standardized test methods (ASTM standards) and in-vivo electromagnetic simulation.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

• Not applicable.

Important Note:

The letter does mention, "A clinical literature summary was provided to support the expansion of indications." This indicates that existing clinical data from published literature was used to support the broadened indications for use of the device, rather than a new, dedicated clinical trial being conducted for this 510(k) submission. However, details of this literature review are not provided in the letter.

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Indications remain unchanged from pre-pandemic COVID-19 vaccines for use in individuals 6 months of age and older.

HPE 8570B 50 Ohm Programmable Step Attenuator, DC to 18 GHz

This FDA clearance letter for the Arthrex Spine Endoscope (K243602) does not contain information about the development and validation of an AI/ML device. Instead, it describes a traditional medical device submission for an endoscope.

The letter explicitly states on Page 6: "The Arthrex Spine Endoscope did not require animal testing or human clinical studies to support the determination of substantial equivalence." and "All verification activities were successfully completed to confirm the subject device meets product requirements and design specifications established for the device." This indicates that the clearance was based on non-clinical bench testing and comparison to a predicate device, typical for traditional medical devices, rather than a novel AI/ML algorithm requiring extensive clinical validation with ground truth, expert readers, and comparative effectiveness studies.

Therefore, I cannot extract the requested information about acceptance criteria and study proving an AI/ML device meets those criteria from this document. The document pertains to a physical endoscope, not an AI/ML system.

If you have a different document pertaining to an AI/ML medical device, please provide it, and I will do my best to extract the requested information.

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The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.

The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

The provided FDA 510(k) clearance letter and summary for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) describes the device and its indications for use, but does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically, the document states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This implies that performance data demonstrating device capabilities against specific acceptance criteria (beyond general functional testing and compliance with standards) were not generated through clinical studies or animal studies for this submission.

However, based on the information provided, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Since no human or animal clinical studies were performed, there appears to be no specific clinical performance acceptance criteria listed in this document. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing.

Study Details (Based on Provided Document and Inferences)

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

   • Test set sample size: Not applicable for clinical performance as the document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."
   • Data provenance: Not applicable for clinical performance. The data provenance for engineering tests (e.g., EMT, EMC, software) would be internal Arthrex testing labs.

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

   • Not applicable as no human clinical studies establishing ground truth for clinical performance were conducted for this submission. Ground truth for engineering tests is established through technical specifications and industry standards.

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

   • Not applicable for clinical performance.

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 MRMC study was done. The device description does not indicate AI assistance features. The system is described as an endoscopic video camera and imaging system, not an AI-powered diagnostic aide.

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

   • Not applicable. The device is hardware (imaging system) with associated software, not a standalone algorithm.

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

   • For the engineering and regulatory compliance tests: Ground truth was established by adherence to design specifications, industry standards (e.g., for biocompatibility, sterility, EMT, EMC), and internal product requirements.
   • For clinical performance (e.g., diagnostic accuracy for a specific disease): No such ground truth was established or presented as no clinical studies were performed.

7. The sample size for the training set:

   • Not applicable, as this device does not appear to utilize machine learning for clinical interpretation or outcome prediction in a way that requires a "training set" in the context of AI/ML models. "Software testing" refers to verification against technical requirements, not AI model training.

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

   • Not applicable for the same reasons as #7.

Summary of Key Takeaways from the Document:

The 510(k) clearance for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) is based on substantial equivalence to existing predicate devices (K241361 and K243008). The justification for this clearance relies heavily on:

• Similar intended use and indications for use.
• Similar technological characteristics (e.g., components, imaging modes, specifications).
• Successful completion of engineering and regulatory compliance testing (e.g., functional testing, biocompatibility, sterility, EMT, EMC, software).

Crucially, the document explicitly states that no animal testing or human clinical studies were required or performed to demonstrate the device meets acceptance criteria related to clinical performance. This means the clearance is not based on a study proving diagnostic accuracy or clinical effectiveness in patients, but rather on the device's technological similarity and safety/performance in a non-clinical, engineering test environment compared to previously cleared devices.

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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

The provided document is a 510(k) premarket notification for a medical device, the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic or prognostic tool.

Therefore, many of the requested elements regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, and standalone performance for an AI/algorithm are not applicable to this document. This document details the physical characteristics of a mechanical medical device and its performance through mechanical testing and biocompatibility assessment.

However, I can extract information related to the performance data and the comparison to the predicate device, which serves a similar function to demonstrating "acceptance criteria" in the context of a 510(k) submission for a physical device.

Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of the document:

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

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

• Sample Size: The document does not explicitly state the sample size used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was conducted."
• Data Provenance: The data was generated by Arthrex Inc. in the context of demonstrating substantial equivalence for their new device. There is no mention of country of origin of the data or whether it was retrospective or prospective in the context of a clinical study, as this is a device performance test.

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 mechanical device, and "ground truth" is established through physical testing standards and specifications (e.g., measured pull-out strength, endotoxin levels), not expert interpretation of diagnostic images or data.

4. Adjudication method for the test set:

• Not Applicable. As above, mechanical tests do not involve adjudication by multiple human 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:

• Not Applicable. This document pertains to a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering and material science standards and specifications. For example:
  • Mechanical strength: Measured values from cyclic pull-out tests that are compared against predefined performance benchmarks or the performance of a legally marketed predicate device.
  • Biocompatibility: Demonstrated through adherence to established biocompatibility testing standards (e.g., ISO 10993) and comparison to a predicate device with a known biocompatibility profile.
  • Sterility: Demonstrated through validated sterilization processes and testing to ensure compliance with sterility assurance levels.
  • Pyrogenicity: Demonstrated by a bacterial endotoxin test meeting specified limits.

8. The sample size for the training set:

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

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

• Not Applicable. This is not an AI/algorithm device.

Summary of the study proving the device meets the "acceptance criteria" (i.e., substantial equivalence):

The study described is a performance testing study primarily focused on cyclic pull-out testing and bacterial endotoxin testing.

• Purpose: To demonstrate that the new Arthrex FiberTak Suture Anchor performs equivalently to its primary predicate device (K221396) and meets safety specifications.
• Methodology:
  • Cyclic Pull-out Testing: Performed on the new device. The results were then compared statistically to the performance of the predicate device (K221396). The document states the new device "performs statistically equivalent to the primary predicate device."
  • Bacterial Endotoxin Testing: Conducted per EP 2.6.14/USP to ensure the device meets pyrogen limit specifications.
  • Technological Comparison: The submission also relies on a detailed technological comparison, stating that the subject device is a line extension with "identical basic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, overall manufacturing, and sterilization processes" to the predicate. The only stated modification is to the pre-loaded sutures, and this difference is considered minor, not raising new questions of safety or effectiveness.
• Conclusion: Based on the performance data and technological comparison, Arthrex determined that the subject device is substantially equivalent to the currently marketed primary predicate device, implying it meets the necessary performance and safety criteria for its intended use.

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The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in submissions for AI/ML-based medical devices. The document describes a traditional 510(k) premarket notification for a Class II metallic bone fixation appliance (Arthrex Humeral Plating System and Cerclage Button).

The "Performance Data" section mentions mechanical testing (4-point bend, MRI compatibility) and bacterial endotoxin testing, which are standard for orthopedic implants to demonstrate engineering performance and biocompatibility compared to predicate devices. However, this is not a study proving an AI/ML device meets clinical acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you listed, such as sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device described in this document.

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The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded knotless suture anchor that is pre-loaded on a disposable inserter with Arthrex sutures. The anchor may be manufactured from either BioComposite (PLLA/betaTCP TriCalcium Phosphate) or PEEK (Polyether-ether-ketone). The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is provided sterile (Ethylene Oxide), single-use, and is packaged in a single-pack or 5-pack.

The provided document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The "Performance Data" section of the 510(k) summary (page 4) states:
"Tensile (pull-out) testing was conducted on the proposed Arthrex 4.75 mm Doubled Loaded Knotless Corkscrew Suture Anchor submitted in this Special 510(k). The test data demonstrates that the proposed device performs statistically equivalent to the predicate device for the intended indications for use. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that mechanical and biocompatibility tests were performed, but no acceptance criteria or detailed study results for an AI/ML device performance are present. The document is for a physical medical device (suture anchor), not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML system cannot be extracted from this document.

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