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The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

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 FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.

The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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Iconix Speed Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

The Iconix Speed Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable self-punching inserter. The device is composed of a braided polyester anchor body that contains two or three working sutures. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Speed Anchors 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 classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided FDA 510(k) clearance letter and summary for the Iconix Speed Anchor does not describe a study that involves software performance, AI algorithms, or human-in-the-loop assessments. Instead, it describes mechanical and biological performance testing for a physical medical device (bone anchor).

Therefore, I cannot provide details for most of your requested points, as they are specific to AI/software device studies.

However, I can extract the information related to the device's performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and the Reported Device Performance

The 510(k) summary states that "Results of performance testing for the Iconix Speed Anchor device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix Speed Anchor met all requirements for its intended use."

However, the document does not explicitly state specific quantitative acceptance criteria (e.g., "pullout strength > X N") or the exact reported performance values for the Iconix Speed Anchor in these tests. It only states that the device performed "comparably" to the predicate.

The following information cannot be provided as the provided document describes a physical medical device (bone anchor), not an AI/software device study.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical units of the device subjected to mechanical and biological testing, not a dataset for an AI model. The document does not specify the number of samples for each mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical performance is typically established through direct physical measurement under controlled conditions, not expert consensus.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical tests (insertion, cyclic, pullout), the "ground truth" is the measured physical performance of the device. For biological tests, it's compliance with ISO standards. For usability, it's observation in cadaveric models.
8. The sample size for the training set: Not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.

The RootMend Meniscal Root Repair (MRR) devices are composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. RootMend MRR devices are available with a fixation button composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. RootMend MRR devices will be provided sterile using ethylene oxide, for single use only, and are not to be resterilized. The UHMWPE is available undyed (white), black, or blue, with trace filaments of black or blue. RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.

The provided text from the FDA 510(k) summary for the RootMend MRR device states that "Non-clinical mechanical testing was performed to verify the fixation strength of the RootMend MRR devices and is compared to the predicate device. Testing conducted includes cyclic and ultimate tensile strength (UTS) testing, and assessment of displacement for the subject button and predicate anchor constructs. Usability engineering testing with simulated use in cadaver lab was performed on the subject device per EN62366-1. In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."

However, the provided document does not contain the specific acceptance criteria or the detailed results (e.g., reported device performance values) from the mechanical testing and usability testing. It also lacks information regarding sample size, ground truth establishment, expert qualifications, or MRMC studies that would be relevant for an AI/software device evaluation.

Therefore, I cannot fulfill the request the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: Not provided.
• Sample sized used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device and testing described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is a hardware device, not an AI/software device assisting human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is the specified performance thresholds (acceptance criteria) and the measured physical properties. For usability testing, the 'ground truth' is successful completion of tasks by users in a cadaver lab. Specifics are not detailed beyond "performed as intended."
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Based on the available information, here is what can be inferred or directly stated:

1. Acceptance Criteria and Device Performance:

The document states: "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."

• Acceptance Criteria: Not explicitly stated in quantitative terms. They likely relate to minimum cyclic and ultimate tensile strength, and maximum displacement relative to the predicate device.
• Reported Device Performance: Not explicitly stated in quantitative terms. The performance met the unstated acceptance criteria.

2. Sample Size and Data Provenance:

• Sample Size: Not specified for any of the tests (cyclic, UTS, displacement, usability).
• Data Provenance: The tests were "non-clinical mechanical testing" and "usability engineering testing with simulated use in cadaver lab." This implies laboratory/bench testing rather than human clinical data. The location of the testing or data origin (country) is not specified.

3. Experts for Ground Truth / Adjudication / MRMC studies / Standalone Performance:

• These concepts (experts, adjudication, MRMC, standalone performance) are typically relevant for AI/software-based medical devices that interpret medical images or data. The RootMend MRR is a physical orthopedic implant (metallic bone fixation fastener). Therefore, these criteria are not applicable to the device and studies described.

4. Type of Ground Truth:

• For mechanical testing: The ground truth is established by engineering specifications and comparative performance to a predicate device. This would involve objective measurements of strength, fatigue, and displacement against predefined thresholds.
• For usability testing: The ground truth is successful completion of surgical tasks and safe operation in a simulated environment (cadaver lab) as assessed by the test protocol and observations.

5. Training Set Information:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a "training set."
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided FDA 510(k) summary provides a high-level statement that the device met acceptance criteria through specified non-clinical mechanical and usability testing, but it does not disclose the quantitative details of those criteria, the measured performance, or the sample sizes used. The remaining questions are not relevant given the nature of the device as a physical implant rather than an AI/software product.

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The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair

The Riverpoint Medical Interfacing Anchor is comprised of a pre-deployed all-suture anchor with attached repair sutures and 302 stainless steel needles. The Interfacing Anchor is inserted into either the humerus or into passing slots available in devices intended for total shoulder arthroplasty. The Riverpoint Medical Bone Tunnel Construct is comprised of a double armed Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a preassembled polypropylene passing loop and 302 stainless steel needles. Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA authorized. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Interfacing Anchor and Bone Tunnel Construct are available in common sizes and lengths with preattached 302 stainless steel needles and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text is a 510(k) summary for the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct. This document details the regulatory review process for a medical device and its substantial equivalence to a predicate device.

It does NOT describe an AI/ML-driven medical device, nor does it contain information about diagnostic performance metrics (e.g., sensitivity, specificity, AUC), test set characteristics, expert adjudication processes, or MRMC studies.

The "Performance Data" section of the document refers to non-clinical performance testing for a surgical device (an anchor and tunnel construct), not a diagnostic AI. The tests mentioned are:

• Usability engineering validation with simulated use in cadaveric models (EN62366:2015)
• Endotoxin/pyrogenicity testing (ANSI/AAMI ST72:2019, USP , USP , USP )
• Mechanical testing to verify fixation strength (cyclic and pullout testing)

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided text pertains to a physical surgical device.

To directly answer your prompt based on the provided text, the following cannot be extracted:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (as it's not a diagnostic device). The acceptance criteria mentioned are for mechanical and usability performance of a surgical implant.
• Sample sizes used for a "test set" in the context of image analysis or diagnostic performance. The "test set" here refers to cadaveric models and mechanical testing samples.
• Data provenance (country of origin, retrospective/prospective) for a diagnostic dataset.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for the training set was established.

However, based on the provided text, here's what can be inferred or directly stated about the "acceptance criteria" and "study" for this specific device (a surgical implant):

Acceptance Criteria and Device Performance (for a surgical implant):

Study Details (for this surgical implant):

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

   • The "test set" refers to samples for mechanical testing and cadaveric models for usability. Specific numerical sample sizes are not provided in this summary.
   • Data provenance is not described (e.g., where the cadavers came from, or if the mechanical tests were done by a specific lab).
   • The studies were non-clinical ("bench testing" and "simulated use").

2. 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 in the context of diagnostic "ground truth." The "ground truth" for a surgical implant's mechanical performance is defined by engineering standards and comparative testing to predicates. Usability testing would involve typical users (surgeons, OR staff), but the number or qualifications are not specified.

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

   • Not applicable as this is not a diagnostic study requiring human expert consensus/adjudication of results. Performance is measured against physical test standards and engineering specifications.

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

   • No, a MRMC comparative effectiveness study was not done. This is a physical surgical device, not an AI/ML diagnostic tool.

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

   • Not applicable as this is a physical surgical device, not an algorithm.

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

   • For mechanical testing: Engineering specifications and comparative performance to a legally marketed predicate device.
   • For usability testing: Performance in simulated use conditions in cadaveric models against predefined usability objectives (derived from EN62366:2015).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device with a "training set."

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

   • Not applicable.

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The 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, 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, 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 to bone 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 inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The size of the anchor of the subject device is 1.4mm. Iconix Knotless Anchor will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text pertains to an FDA 510(k) premarket notification for a medical device called the "Iconix Knotless Anchor." It outlines the device's description, intended use, and the basis for its substantial equivalence to a previously cleared predicate device.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a physical medical device (knotless anchor for soft-tissue to bone fixation), not an AI/ML algorithm.

Therefore, I cannot provide the requested information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the physical medical device described in the document.

The document discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) and other validations (shelf-life, sterilization, biocompatibility, packaging stability, usability engineering) to demonstrate that the device performs comparably to its predicate and meets requirements for its intended use. This is typical for physical medical devices but does not align with the AI/ML-focused questions in your prompt.

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The OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor are intended for use in soft tissue to bone fixation in the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
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 OC JuggerKnotless® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to two non- absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, or black Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

The OC JuggerLoop® Soft Anchor is comprised of a suture sleeve structure and shuttling and cinching suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to two non-absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, or black. Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a standard or self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use, OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor 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.

The provided text describes a medical device, the OC JuggerKnotless Soft Anchor and OC JuggerLoop Soft Anchor, and its substantial equivalence to a predicate device. However, it does not contain information typically associated with the acceptance criteria and study design for AI/ML-based medical devices. The document is an FDA 510(k) clearance letter and summary for a physical medical device (bone fixation fastener), not a software or AI/ML device.

Therefore, the requested information regarding acceptance criteria, reported device performance in a table, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document because these concepts are not applicable to the type of device described.

The document discusses the following:

• Device Type: Soft Anchors for soft tissue to bone fixation.
• Regulatory Classification: Class II medical device (21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener).
• Performance Data: Non-clinical mechanical testing (insertion, cyclic, and pullout testing) and usability engineering validation in cadaveric models.
• Conclusion: The device is substantially equivalent to a predicate device based on intended use, principle of operation, materials, packaging, sterilization, and comparable performance in non-clinical testing.

If you have a document pertaining to an AI/ML medical device, please provide that for analysis.

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The RibFix Titan Fixation System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The Riverpoint Medical RibFix Titan Fixation System is comprised of titanium bone plates that are secured to bone by a deplovable ultra-high molecular weight polyethylene (UHMWPE) suture anchor with a titanium washer and button. Bone plates are provided in configurations for intrathoracic and extrathoracic use. Intrathoracic bone plates are provided in 60mm and 94mm lengths. Extrathoracic bone plates are provided in 60mm, 94mm, and 120mm lengths.

The provided text does not contain detailed acceptance criteria or results of a study proving the device meets those criteria in a tabular format as requested for all points. The document is a 510(k) summary for the RibFix Titan™ Fixation System, which describes performance testing generally but does not provide specific metrics, acceptance criteria, or detailed study results.

However, based on the limited information available, here's what can be extracted:

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

The document states: "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended." However, no specific numerical acceptance criteria or performance metrics are provided in the document.

2. Sample size 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 sample sizes for mechanical testing or usability validation, nor does it provide information on the data provenance (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):

Not applicable. The reported studies are mechanical and usability engineering, not clinical studies requiring expert ground truth for diagnosis/assessment.

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

Not applicable. This is not a clinical study involving human judgment on cases.

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 a medical device (fixation system), not an AI/software device involving human readers.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable. For the mechanical and usability testing mentioned:

• Mechanical testing: Ground truth would be defined by engineering specifications and physical measurements according to standards like ASTM F382 (for plate components) and ASTM F1717 (for assembled constructs).
• Usability engineering validation: Ground truth would be the defined usability goals and safety requirements, assessed through expert evaluation and simulated use.

8. The sample size for the training set:

Not applicable. This is not a machine learning/AI study involving a training set.

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

Not applicable. This is not a machine learning/AI study.

Summary of available information regarding studies:

The document mentions the following non-clinical performance data studies were conducted:

• Four-point bend testing (static and fatigue) of bone plate components per ASTM F382.
• Cyclic and Ultimate Tensile Strength (UTS) testing of anchor constructs.
• Cyclic fatigue testing of assembled constructs using ASTM F1717 as a guide.
• Usability engineering validation with simulated use in cadaver lab performed per EN62366-1.
• MR Compatibility testing per ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182.

The document states that "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended." It also mentions that the testing compared the RibFix Titan Fixation System to the predicate device, especially regarding fixation strength. For usability, it notes that the "usability study and performance testing of the RibFix Titan support the use of the RibFix Titan Fixation System and eIFU."

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The 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: 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 Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valqus 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® Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one or more working sutures. Sutures supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved (K100006 and K190817). The standard and the self-punching inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The Iconix® Anchors size is 2.3mm. The anchors will be sold sterile for single use with no components or accessories. The product is intended to be used with the same accessories used to implant the predicate device. The device is intended for use in a hospital/clinic/surgical setting, and it is intended for adults only.

The provided text describes a 510(k) premarket notification for a medical device called "Iconix® Anchor." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to a previously cleared predicate device.

It is crucial to understand that a 510(k) submission for a non-AI/ML device like the Iconix® Anchor typically does not involve the types of studies, acceptance criteria, multi-reader multi-case (MRMC) studies, or ground truth establishment that are relevant for AI/ML-driven diagnostic devices. The questions posed in your prompt are highly specific to AI/ML software as a medical device (SaMD) or AI-augmented medical devices.

The Iconix® Anchor is a physical medical device (a soft-tissue to bone fixation fastener), not an AI/ML diagnostic or therapeutic system. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are centered around mechanical performance, biocompatibility, sterilization, and substantial equivalence to a predicate device, rather than diagnostic accuracy, reader performance, or AI model metrics.

Based on the provided document, here's how the information relates to your questions, highlighting the differences for a physical device:

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

The document does not present a formal "table of acceptance criteria" with reported performance metrics in the way one would for an AI/ML algorithm (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicit in meeting the performance requirements for a bone anchor, and the reported performance is qualitative, stating that the device "met all requirements for its intended use" and "performed comparably to the predicate device."

Regarding AI-specific questions (2-9), the nature of this submission means most are not applicable or the information is not provided because it's not a software/AI device:

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 in the AI/ML sense. The "test set" for a physical device refers to the physical samples tested for mechanical properties, biocompatibility, etc. The document does not specify the number of individual anchors tested, only the types of tests performed (insertion, cyclic, pullout testing) and that cadaveric models were used for usability.
• Data provenance (country of origin, retrospective/prospective) is not relevant for physical device testing in this context.

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 in the AI/ML sense. "Ground truth" for this device is established by physical measurements and engineering validation against established standards (e.g., ISO, USP) and comparison to a predicate device's performance, not by expert consensus on image interpretation. For usability, medical professionals might have been involved in the cadaveric testing, but their number and specific qualifications are not detailed.

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

• Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for mechanical and biological testing of a physical 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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is not an AI diagnostic tool.

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

• Not applicable. This question pertains to the performance of an AI algorithm independent of human interaction. The Iconix® Anchor is a physical implant, not an algorithm.

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

• For the physical device: The "ground truth" is based on engineering standards, validated test methods (e.g., ISO, USP), and direct physical measurements of properties like tensile strength, insertion force, pullout strength, and biocompatibility. Usability was evaluated using simulated use in cadaveric models.

8. The sample size for the training set

• Not applicable. This question is for AI/ML algorithms. The Iconix® Anchor does not have a "training set" in the machine learning sense. Any design iterations or preliminary testing during development would be more akin to "training," but not in the data science context.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant.

In summary: The provided document is a 510(k) for a physical medical device (a bone anchor), not an AI/ML-driven diagnostic or therapeutic device. The "acceptance criteria" and "study" described are focused on the mechanical, biological, and sterility performance of the physical product, and its substantial equivalence to a predicate device, rather than the performance metrics typically associated with AI/ML systems. Therefore, most of your specific questions related to AI/ML study design are not addressed in this type of regulatory submission.

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OC JuggerKnot® Soft Anchor are intended for use in soft tissue to bone fixation for the following indications:

The OC JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three non- absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. OC JuqgerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles 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.

The provided text describes a medical device, the "OC JuggerKnot® Soft Anchor," and its FDA 510(k) submission for substantial equivalence. However, the document does not contain the specific acceptance criteria, reported device performance metrics in a table, or details of a study that proves the device meets specific performance criteria in the format the user requested.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (K232411 – Riverpoint Medical JuggerKnot® Soft Anchor with OC Coating) and a reference device (K231128 – Riverpoint Medical JuggerKnot® Soft Anchor).

Based on the information provided, here's what can be extracted and what is missing:

Missing Information:

• A table of specific numerical acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Detailed results of a standalone (algorithm only) performance study.
• Specific ground truth type (e.g., pathology, outcomes data) for non-mechanical tests.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information that can be inferred or directly stated from the document regarding the study and performance:

The document mentions non-clinical mechanical testing and usability engineering validation.

Study Description (Inferred and direct quotes):

The device underwent non-clinical mechanical testing and usability engineering validation.

• Non-clinical Mechanical Testing:

  • Purpose: To verify the fixation strength of the OC JuggerKnot® Soft Anchor with self-punching inserter.
  • Types of tests: Insertion, cyclic, and pullout testing.
  • Comparison: Compared to the predicate device and other currently marketed soft anchor devices with self-punching inserters.
  • Conclusion: "Results of performance testing for the OC JuggerKnot® Soft Anchor device with self-punching inserter concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing and the validations performed demonstrated that the OC JuggerKnot® Soft Anchor with selfpunching inserter met all requirements for its intended use."

• Usability Engineering Validation:

  • Purpose: Performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices.
  • Methodology: Involved "simulated use in a cadaveric models."

• Other Testing Mentioned:

  • Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP , USP and USP .
  • Suture testing per USP performance requirements for needle attachment and tensile strength.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance:
   Not explicitly provided in the document. The document states that "the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing" and "met all requirements for its intended use," but specific numerical criteria and corresponding performance values are absent.

2. Sample size used for the test set and the data provenance:
   Not explicitly stated for the mechanical testing or usability studies. For the usability study, it mentions "cadaveric models" but not the number. Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable or not stated as this is a physical medical device, not an AI/software system requiring expert consensus for ground truth on disease detection. The "ground truth" for mechanical testing would be the physical outcome measurements.

4. Adjudication method for the test set:
   Not applicable or not stated.

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 surgical anchor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing, the ground truth would be physical measurements of fixation strength (e.g., load at failure, displacement) under controlled conditions. For usability, it would involve evaluation of user interaction and safety in a simulated environment.

8. The sample size for the training set:
   Not applicable as this is a physical device.

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

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The 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, 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, 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 to bone 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 inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Knotless 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.

The classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

This document is a 510(k) Pre-market Notification for a medical device called the "Iconix Knotless Anchor." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable based on the provided text.

Here's an analysis based on the information available:

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

The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it describes comparative performance testing against a predicate device.

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

The document does not specify the sample sizes for the mechanical tests (insertion, cyclic, pullout). It mentions "simulated use in a cadaveric models" for usability engineering, but the number of cadaveric models is not provided, nor is the country of origin. The data provenance details are largely absent.

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

This is not applicable as the document describes engineering and biocompatibility testing, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This is not applicable.

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 a surgical anchor, 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 surgical anchor.

7. The type of ground truth used

For mechanical testing (insertion, cyclic, pullout), the "ground truth" would be the measured mechanical properties of the device itself and the predicate. For biocompatibility, it's compliance with ISO standards. For packaging and sterilization, it's compliance with relevant ISO standards and validation protocols. For the usability engineering, it was simulated use in cadaveric models.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device.

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

This is not applicable.

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