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JuggerKnot Soft Anchor OC are intended for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair Hip Hip Labral reconstruction Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC 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. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. 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. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.

The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.

Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:

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

   • Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
   • Reported Device Performance:
     • Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
     • Sterilization: "sterilization adoption validation"
     • Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
     • Stability: "stability testing on the product packaging per ISO 11607-1:2006"
     • Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
     • Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>."

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

   • Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
   • Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
   • Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.

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 is not applicable as the device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.

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

   • This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.

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. The device is an implantable fastener, not an AI-assisted diagnostic tool.

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

   • This is not applicable. The device is a physical implant, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.

8. The sample size for the training set:

   • This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.

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

   • This is not applicable for the reason stated above.

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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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Iconix® Knotless 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 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, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

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

The Iconix® Knotless Anchors are soft-tissue fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.

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 metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The anchor size will be available in 1.4mm with working sutures in standard USP size 2. Iconix® Knotless Anchor will be sold sterile for single use with no components or accessories.

The provided document is a 510(k) summary for the Iconix® Knotless Anchor, a medical device used for soft-tissue to bone fixation. It describes the device, its intended use, and its equivalence to a predicate device (Stryker ICONIX Anchors).

However, this document does not contain any information about a study involving AI/algorithm performance or human-in-the-loop studies. It focuses solely on the mechanical and biological safety of the physical medical device (the knotless anchor itself) in comparison to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/algorithm performance. The document only discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) to demonstrate performance comparability of the physical anchor to a predicate device, and standard safety validations (sterilization, biocompatibility, stability, usability engineering).

In summary, there is no information in the provided text that relates to:

• Acceptance criteria for an AI/algorithm (e.g., sensitivity, specificity, AUC)
• Sample sizes for algorithm testing (test sets, training sets)
• Data provenance for AI/algorithm development or testing
• Number/qualifications of experts for AI ground truth
• Adjudication methods for AI ground truth
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth for AI (pathology, outcomes data, etc.)
• Training set size or ground truth establishment for an AI algorithm

The document focuses on the equivalency of a physical medical device (a bone anchor) and its mechanical properties.

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HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

• · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
• · Repair of long bone fracture due to trauma or reconstruction.

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.

Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.

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

This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.

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

A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies were:

• Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
• Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.

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

This information is not applicable for the same reason as point 8.

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The Riverpoint Medical OrthoButton® AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

The Riverpoint Medical OrthoButton® AL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6A1-4V ELI per ASTM F136) plate. The device is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

This document does not describe an AI/ML powered device, nor does it describe software that provides automated analysis or diagnosis. The device, OrthoButton® AL, is a physical medical device (Fastener, Fixation, Non-Degradable, Soft Tissue) used in orthopedic procedures. Therefore, the questions related to acceptance criteria, AI performance, ground truth, and study design for an AI/ML system are not applicable to this submission.

The document discusses performance data related to the physical device's characteristics (sterilization, biocompatibility, stability, usability) and its substantial equivalence to a predicate device.

To answer your request, if this were an AI/ML device, the relevant information would typically be found in a section detailing "Software Verification and Validation" or "Clinical Performance Studies" specifically for the algorithmic aspects. This document focuses on the physical properties and intended use of a mechanical medical device.

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HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This submission is for a medical device (HS Fiber surgical suture) and not an AI/ML powered device, therefore most of the requested information cannot be extracted from the text. The document describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

However, based on the provided text, here is the information related to the acceptance criteria and performance data for the device:

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

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

The document does not specify the exact sample sizes used for the testing. It generally states that the device "meets requirements" and "is tested," but doesn't provide specific numbers of units tested. The provenance of the data is not mentioned (e.g., country of origin, retrospective/prospective).

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 is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that would require expert-established ground truth for a test set.

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

This is not applicable as the submission is for a physical medical device (suture). Testing involved adherence to established physical and biological standards, not image or data interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device.

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

This is not applicable as the submission is for a physical medical device (suture).

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

The "ground truth" for the device's performance is based on established, objective, and quantitative performance standards set by:

• United States Pharmacopeia (USP) standards for physical properties like tensile strength and needle attachment.
• ISO 10993-1:2018 (Biological Evaluation of Medical Devices) for biocompatibility.
• FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers" for endotoxin levels.

8. The sample size for the training set

This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that requires a training set. The device is manufactured according to specifications and tested for compliance.

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

This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device.

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