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The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
• Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Liqament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
• Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal 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 Repair
• 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: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Tigon Medical All-Suture Anchors are soft-tissue fixation devices provided sterile, preloaded on an inserter. The anchor consists of different load configurations consisting of one or more working sutures. The inserters can be reprocessed after use and are made from stainless steel.

This document is a 510(k) premarket notification for a medical device (Tigon Medical All-Suture Anchors). It does not include information about AI/ML device performance or clinical studies with human readers. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, or expert qualifications for ground truth establishment.

The document discusses the substantial equivalence of the device to legally marketed predicate devices based on mechanical testing, specifically according to ASTM F543. The acceptance criteria and "performance" in this context relate to the physical and mechanical properties of the anchor itself, not the performance of an AI/ML algorithm.

Here's the information that can be extracted or inferred from the provided text, related to the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not applicable for an AI/ML study. The "test set" here refers to the samples of the medical device used for mechanical testing. The specific sample size for the mechanical testing is not explicitly stated in this document. Data provenance would refer to the origin of the mechanical test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is not an AI/ML study involving human interpretation of medical images or data. Ground truth in this context would be established by the mechanical testing protocols and measurements.

4. Adjudication method for the test set:
Not applicable as this is not an AI/ML study requiring expert adjudication of results. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

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 document pertains to the clearance of a physical medical device (all-suture anchors), not an AI/ML-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, standalone algorithm performance was not done. This document is not about an algorithm.

7. The type of ground truth used:
The "ground truth" for the device's performance is established through mechanical testing (per ASTM F543) comparing the device's physical properties (e.g., insertion strength, fixation strength) to those of predicate devices.

8. The sample size for the training set:
Not applicable, as this is not an AI/ML study.

9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML study.

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The Q-FIX\ Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications:

Shoulder:

• · Bankart lesion repair
• · SLAP lesion repair
• · Acromio-clavicular repair
• · Capsular shift/capsulolabral reconstruction
• · Deltoid repair
• · Rotator cuff tear repair
• · Biceps tenodesis

Foot & Ankle:

• · Medial/Lateral repair and reconstruction
• · Midfoot and forefoot repair
• · Hallux valgus reconstruction
• · Metatarsal ligament/tendon repair or reconstruction
• · Achilles tendon repair

Elbow:

• · Ulnar or radial collateral ligament reconstruction
• · Lateral epicondylitis repair
• · Biceps tendon reattachment

Knee:
· Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament

• · Iliotibial band tenodesis (IBT)
• · Patellar tendon repair
• · Vastus medialis obliquus advancement (VMO)
• · Joint capsule closure

Hip:

· Acetabular labral repair

The Smith & Nephew Q-FIX® Knotless All-Suture Anchor is a fixation device intended to provide fixation of soft tissue to bone. The device consists of an all-suture anchor preloaded with one (1) transfer suture and either one (1) ULTRABRAID® or MINITAPE® suture assembled inside an insertion device. The device is supplied sterile, for single use only.

The 1.8mm implant (all-suture anchor) is made of braided polyester with either one strand of ULTRABRAID® or MINITAPE® suture and one transfer suture pre-loaded. The ULTRABRAID®, MINITAPE®, and transfer sutures are non-absorbable sutures of ultra-high molecular weight polyethylene (UHMWPE). The Q-FIX® Knotless All-Suture Anchor has a knotless suture locking mechanism that provides adjustable one-way tensioning.

The provided text is a 510(k) summary for a medical device (Q-FIX® Knotless All-Suture Anchor). It details the device's characteristics, intended use, and comparison to predicate devices, but does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study.

The "Performance Data" section briefly mentions "Non-clinical bench testing" including "insertion testing, cyclic loading testing, load to pass testing, and knot tensile strength testing." It states that "the device met all required specifications for each test" and "Results for all tests passed." However, it does not provide:

• A table of acceptance criteria and reported device performance for these bench tests. It only states that the device "met all required specifications" and "Results for all tests passed."
• Information related to AI/human reader performance, study design, expert involvement, or ground truth establishment. This type of information is typically found in submissions for AI-enabled medical devices or diagnostic tools where human interpretation or an algorithm's classification performance is being evaluated. The Q-FIX® Knotless All-Suture Anchor is a physical implant, not an AI/diagnostic software.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specific sub-points (1-9), because the provided text describes a physical medical device and not a diagnostic or AI-enabled device requiring such a study. The "performance data" section is about the physical and mechanical properties of the anchor, not clinical diagnostic performance.

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The Stryker ICONIX anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, 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 Repair.

Hand/Wrist: Scaphulolunate 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 Repair.

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, Illiotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/Reconstruction, Quadriceps Tendon Repair.

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair.

The Stryker ICONIX Anchors are intended for single use only.

The ICONIX Anchors, ICONIX TT Anchors, and ICONIX Anchors with Needles are soft tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. ICONIX Anchors with Needles have needles attached to the free ends of all working sutures. All of the ICONIX All-Suture Anchors are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone. Once the anchor has been inserted in the bone, the working sutures are used to complete the soft tissue repair or reconstruction procedure, in accordance with the surgeon's preferred technique for procedures within the indications for use.

The provided text is a 510(k) summary for a medical device (ICONIX All-Suture Anchor) seeking to expand its indications for use. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, study details, or performance metrics in the context of an AI/ML study.

Therefore, I cannot fulfill your request as it pertains to AI/ML device performance. The document focuses on demonstrating substantial equivalence to predicate devices for expanded surgical procedures, not on the performance of a new AI algorithm.

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The Shadow Knotless All-Suture Anchors are intended to be used for fixation of 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, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

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

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.

The Shadow Knotless All-Suture Anchor is a modified version of the Responsive Arthroscopy (RA) Mini Stealth All-Suture Anchors that were previously cleared under K230094. The subject Shadow Knotless device is a suture anchor intended for the fixation of soft tissue to bone. The Shadow device features a knotless, push-in design and is comprised entirely of suture material configured to provide an anchor in bone. The anchor creates a secure fixation point for the reattachment of soft tissue to bone when it is inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The subject device four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The provided suture passing loop allows the integrated repair suture to be passed through the anchor body when securing the desired soft tissue, while the knotless feature allows the repair suture to be locked in place without tying a knot. The anchors may be delivered arthroscopically using inserters and reusable surgical instruments such as drills, guide tubes, and probes, which are identical to those provided with the predicate Mini Stealth All-Suture Anchors (K230094). The subject Shadow anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.

The subject Shadow device is designed for a 2.1mm diameter pilot hole and is comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE). It is provided with an attached USP #1 UHMWPE nonabsorbable repair suture tail and a UHMWPE suture passing loop that are used to facilitate a repair. All subject device materials are identical to those of the predicate Mini Stealth All-Suture Anchors (K230094).

The primary differences between the subject and predicate devices (K230094) are the additions of the knotless feature, integrated repair suture tail, and suture passing loop. However, these design characteristics are similar to those found in the predicate RA Wedge Push-In Suture Anchors previously cleared under K190446 and K181076. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.

This document is a 510(k) Premarket Notification from the FDA regarding the "Shadow Knotless All-Suture Anchors." It details the device's description, indications for use, technological characteristics, and evidence of substantial equivalence to predicate devices.

The provided text describes a medical device (suture anchors) and its regulatory clearance process, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are specific to the development and validation of AI/ML models in a healthcare context, which are not discussed here.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (suture anchors) to existing cleared devices through bench testing of mechanical properties.

However, I can extract the information that is present concerning the device's performance through bench testing, which serves as its "acceptance criteria" for demonstrating substantial equivalence.

Based on the provided document, here's what can be extracted, interpreted within the context of a physical medical device clearance, not an AI/ML model:

There is no information in this document about an AI/ML-powered device. The device in question is the "Shadow Knotless All-Suture Anchors," which is a physical implantable medical device. Therefore, many of the requested points related to AI/ML validation (e.g., test/training sets, ground truth establishment, MRMC studies, human-in-the-loop performance) are not applicable.

However, I can interpret the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this physical device's non-clinical performance testing.

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

The document states: "Performance testing consisted of design verification testing). All testing met acceptance criteria and demonstrated that the devices met design specifications and performed as intended."

While specific numerical acceptance criteria (e.g., "pullout force must be > X N") are not explicitly listed, the types of tests performed indicate the performance characteristics that were evaluated and met.

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

• Sample Size: Not explicitly stated for each test. The document generally refers to "the subject devices" and "the predicate devices" being tested.
• Data Provenance: The testing was "Nonclinical performance testing" conducted to demonstrate that the device met established performance characteristics and design requirements. This implies laboratory bench testing, not clinical data from patients or a specific country. This is a prospective test specifically for this device's clearance.

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

• Not applicable. This is for a physical device, and "ground truth" as it pertains to expert annotation in AI/ML is not relevant here. The "ground truth" for these tests would be the measurement standards and engineering specifications.

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

• Not applicable. This concept pertains to resolving discrepancies in expert annotations for AI/ML validation. For bench testing, test results are compared against predefined engineering specifications.

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 device is a physical medical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic imaging systems, often in the context of AI.

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

• Not applicable. This applies to AI/ML algorithms. The performance testing described (mechanical tests) is inherent to the device itself.

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

• For physical device testing, the "ground truth" is typically against engineering specifications, material standards, and performance benchmarks derived from predicate devices or established biomechanical principles. It's based on measured physical properties (e.g., force, diameter, strength).

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set for this physical device.

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

• Not applicable. There is no AI/ML training set for this physical device.

In summary, the provided document is a 510(k) clearance letter for a physical medical device (suture anchors), not an AI/ML product. Therefore, most of the specific questions geared towards AI/ML validation are not addressed or applicable within this document. The "acceptance criteria" and "proof" for this device relate to its mechanical performance in non-clinical bench testing, demonstrating that it functions equivalently to previously cleared predicate devices.

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The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, 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 Repair

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.

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

The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.

• Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
• Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
• Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.

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

This question is not applicable in the context of this device and study type.

• For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
• For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.

4. Adjudication Method for the Test Set

This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.

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 is not applicable. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.

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

This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
• Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
• Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device, not an AI/software model that requires a training set.

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

This is not applicable, as there was no training set.

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The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle:

· Medial or lateral instability repairs/reconstructions

· Achilles tendon repairs/reconstructions

The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.

The provided text is a 510(k) summary for the Smith & Nephew Q-FIX® ULTRA All-Suture Anchor. This document describes a medical device and its equivalence to existing legally marketed devices, primarily through bench testing. It does not describe an AI/ML powered device, nor does it involve a study with human readers, ground truth establishment, or typical AI acceptance criteria.

Therefore, many of the requested fields cannot be populated as they are not applicable to this type of device submission.

Here's the information that can be extracted, and explanations for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed."

However, the specific numerical acceptance criteria and the quantitative results for each test are not provided in this summary. The summary only states that the device "met all required specifications" and that "Results for all tests passed."

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

This is not applicable as this is a non-clinical bench study on a physical medical device. There is no "test set" in the context of an AI/ML algorithm. The "test set" would refer to the number of physical devices or constructs tested for each bench test. This information is not provided in the summary.

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

Not applicable. There is no "ground truth" to establish for a physical medical device bench test in the context of human expert review. The evaluation criteria are based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" required for physical device bench testing in the context of human expert disagreement.

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 powered device.

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

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

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

Not applicable. For this type of device, the "ground truth" for performance is based on established engineering principles, material properties, and biomechanical standards against which the device's physical performance is measured.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device. There is no "training set."

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

Not applicable. This is not an AI/ML powered device. There is no "training set" or ground truth in the AI context.

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The Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors are intended to be used for fixation of 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 Repair.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

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

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.

The Stealth and Mini Stealth All-Suture Anchors intended for the fixation of soft tissue to bone. The All-Suture Anchors feature a push-in design and are comprised entirely of suture material configured to provide an anchor in bone. The anchors create a secure fixation point for the reattachment of soft tissue to bone when they are inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The All-Suture Anchors feature four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The All-Suture Anchors may be delivered arthroscopically using inserters and surgical instruments such as drills, guide tubes, and probes.

The subject device systems include two anchor sizes, the Stealth All-Suture Anchor which is designed for a 3.0mm diameter pilot hole and the Mini Stealth All-Suture Anchor which is designed for a 2.1mm diameter pilot hole. Both anchor systems are comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE) material and are available in a variety of configurations containing one or more working USP #2 sutures or 1.5mm suture tapes to facilitate a repair.

The Stealth and Mini Stealth All-Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.

This document describes the premarket notification (510(k)) for the Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors, which are intended for the fixation of soft tissue to bone.

Here's the 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 the data provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of anchors tested for insertion force or cyclic pullout). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The testing was non-clinical, meaning it was likely conducted in a lab setting rather than involving human or animal subjects in a clinical trial.

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

This information is not applicable. The studies described are non-clinical performance and design verification tests, not studies requiring expert interpretation of diagnostic data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable, as the tests are non-clinical performance evaluations with predefined pass/fail criteria rather than requiring expert adjudication of results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies were non-clinical performance tests comparing the subject devices to predicate devices.

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

This concept is not applicable as the device is a medical implant (suture anchor), not an AI algorithm. The performance tests were conducted on the physical device itself.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests was established by predefined engineering specifications, design requirements, and established standards (e.g., ASTM, ISO guidelines), as well as comparative performance to legally marketed predicate devices. For instance, for pullout strength, the ground truth would be a defined force threshold or equivalency to predicate device performance.

8. The sample size for the training set

This information is not applicable. This is a medical device approval based on non-clinical performance testing and substantial equivalence to predicate devices, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above.

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• MectaLock All-Suture Anchor
  The MectaLock All-Suture anchor is intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; cuff rotator repair
• SnugFit All-Suture Anchor
  The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:
• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

The subject devices are implantable devices indicated for the treatment of hip and shoulder instability. The subject SnugFit All-Suture Anchor size 1 is entirely composed of sutures, made up of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET), which are specifically arranged and braided to create an anchoring point within the bone, after their deployment. The sutures themselves, are also used to secure soft tissues to a supporting structure, i.e. bone.
The sterile, individually packaged, subject device is composed of two parts: an all-suture anchor and a driver made of a stainless-steel shaft with an over-moulded plastic handle. The all-suture anchor is provided pre-loaded on the specifically designed disposable driver.
The new SnugFit All-Suture Anchor size 1 is available in two (2) different configurations depending on the driver length (long and short).

This document is a 510(k) premarket notification from the FDA, which assesses the substantial equivalence of modifications to existing medical devices (SnugFit All-Suture Anchor and MectaLock All-Suture Anchor). It does not contain information about software performance, AI algorithm acceptance criteria, or related study details.

Therefore, I cannot provide the requested information regarding acceptance criteria and study data for an AI/software device, as the provided text pertains to a physical medical device (all-suture anchor).

If you can provide a text that describes a medical device with an artificial intelligence/machine learning component, I would be happy to extract the requested information.

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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.

The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively.

The provided document is a 510(k) premarket notification for a medical device called "Fixone All Suture Anchor." This document primarily deals with the substantial equivalence of a new version of the suture anchor to previously cleared predicate devices. It focuses on engineering and biocompatibility testing rather than clinical study data involving AI or human readers evaluating image-based diagnostics.

Therefore, the information required to answer the prompt regarding acceptance criteria and study that proves the device meets the acceptance criteria, specifically related to AI in a clinical setting (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details), is not present in the provided text.

The document discusses acceptance criteria and proof of mechanical performance and biocompatibility for the suture anchor. Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical & Biocompatibility)

Please note that the acceptance criteria are generally implied by the "Requirements" column and "Pass" result, indicating the device met those requirements. Specific numerical requirements are given where applicable.

Anchor Performance

Suture Performance (USP 0, UHMWPE)

Suture Performance (USP 2, UHMWPE)

Suture Performance (USP 0, USP 2, UHMWPE)

Biocompatibility (UHMWPE + PET)

Biocompatibility (Only UHMWPE)

(Same tests and results as UHMWPE + PET table, excluding PET interaction)

Sterilization/Endotoxin

2. Sample size used for the test set and the data provenance:
This information is not provided in the context of an AI/image-based diagnostic test set. The document refers to "bench tests" performed on physical samples of the anchors and sutures. The number of samples for each mechanical test is not specified, only that "each anchor" or "the test article" was evaluated. The data provenance is implied to be from AJU Pharm Co., Ltd.'s internal testing, likely at their facility or a contracted lab. No country of origin for this specific testing data is given, but the company address is in South Korea (A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea). The data is retrospective of the device design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (mechanical and biocompatibility testing). Ground truth is established by objective physical measurements and standardized biological assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device.

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):
For mechanical tests: Physical measurements against engineering specifications (e.g., tensile strength, length, diameter, pull-out force).
For biocompatibility tests: Standardized laboratory assays with pass/fail criteria based on ISO standards.
For sterilization/endotoxin: Standardized laboratory assays (e.g., LAL test) with pass/fail criteria.

8. The sample size for the training set:
Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established:
Not applicable.

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The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip. 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm.

The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm).

The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes.

The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths.

The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm.

All implant components are provided sterile and are designated as single use. The system also includes the reusable surgical instruments required for implantation.

The provided document is a 510(k) summary for medical devices, specifically orthopedic bone fixation appliances. It does not contain information about acceptance criteria for a study, nor does it describe a study that proves a device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or reader studies).

This document is for a traditional medical device (anchors, screws, and cannulas) used in orthopedic surgery. The "study" referenced here is the comparison to predicate devices to demonstrate substantial equivalence, which is a regulatory pathway for market clearance for certain types of medical devices.

Therefore, many of the requested categories in your prompt are not applicable to the content of this FDA 510(k) summary for a physical orthopedic device.

Here's an explanation based on the provided text and why certain sections of your request cannot be fulfilled:

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

• Not applicable / Not provided. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical trial or algorithm test for a new technology like AI/ML. The "performance" described is in terms of material properties, design features, and intended use being similar to predicates.

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 / Not provided. There is no "test set" in the context of an AI/ML algorithm or clinical study described. The "test" in a 510(k) often refers to bench testing (e.g., mechanical strength) which is not detailed in this summary.

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 / Not provided. No ground truth establishment for a diagnostic or prognostic task is mentioned.

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

• Not applicable / Not provided.

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 / Not provided. This device is a physical surgical implant/tool, not an AI-based diagnostic or assistive device.

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

• Not applicable / Not provided. The device is not an algorithm.

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

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided. 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 / Not provided. There is no "training set."

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in a 510(k) context for a traditional device largely revolve around demonstrating substantial equivalence to predicate devices. This is achieved by comparing technological characteristics, intended use, and materials.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) is a qualitative comparison of the new device (OneFix product line) to several predicate devices.

Comparison of Technological Characteristics (as described in the document):

The document explicitly states:
"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems and the predicate devices share the following characteristics:

• Materials of construction
• Manufacturing processes
• Sizes offered
• Product design for shape and macrostructures
• Sterilization methods"

Predicate Devices Used for Comparison:

The devices for which substantial equivalence is claimed are:

• Fixone Biocomposite Anchors; K192484
• Fixone Biocomposite Small Anchors; K192032
• Fixone All Suture Anchors; K192709
• Fixone Interference Screws; K193497
• JOINIX Cannula System; K162070

In conclusion, this document demonstrates that the OneFix product line is substantially equivalent to already cleared predicate devices based on a comparison of their intended use, technological characteristics (materials, manufacturing, size, design, sterilization), and performance (implied to be similar because of the equivalence in characteristics and materials). No specific quantitative performance metrics or studies in the context of AI/ML are presented.

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