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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 EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical and endotoxin tests. It refers to "the worst-case subject EVOL® -SI Joint Fusion System implants" for endotoxin testing, implying a limited number. The data provenance is not specified, but these are typically laboratory-based tests performed by the manufacturer or a contract research organization.

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

This information is not applicable. The device's performance is objectively measured against engineering standards (ASTM) and biological contamination limits (ANSI/AAMI, USP), not against expert interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no human interpretation or adjudication involved in the mechanical or endotoxin testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a medical device (surgical implant) and not an AI/imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

No. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through:

• Established engineering standards: ASTM F543 and ASTM F1264 for mechanical properties.
• Established biological safety standards: ANSI/AAMI ST72 and USP for endotoxin limits.
• Comparison to predicate devices: The "substantial equivalence" is based on the new device's performance meeting or exceeding that of legally marketed predicate devices, which serve as a benchmark for safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.

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

This information is not applicable (see point 8).

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The Half Dome Posterior Lumbar Intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the regulatory approval of a medical device, the HALF DOME Posterior Lumbar Interbody System, and focuses on its substantial equivalence to previously approved predicate devices. It does not present a study proving the device meets specific performance acceptance criteria for an AI or diagnostic algorithm.

The document explicitly states: "No clinical studies were performed" for this specific submission (K172947). Instead, the substantial equivalence claim is based on non-clinical tests (mechanical and material properties) demonstrating similarity to predicate devices.

Therefore, I cannot provide the information requested in your prompt as it pertains to a study evaluating an AI or diagnostic algorithm's performance. The prompt's requirements (e.g., sample size, expert consensus, MRMC study, ground truth) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document are primarily related to:

• Mechanical and material performance: Ensuring the device is structurally sound and made of appropriate biocompatible materials.
• Intended Use: The device performs its designed function within the specified patient population and anatomical locations.
• Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device.

If you had provided a document describing a study for an AI/diagnostic algorithm, I would have extracted the requested information. However, based on the provided text, this is a traditional medical device (implant) approval lacking the type of performance study you are asking about.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment.

The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium allov screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) premarket notification for a medical device called the "Rampart One Lumbar Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic performance. Therefore, the information typically requested in your prompt (such as a table of acceptance criteria, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this document.

The document primarily addresses the device's design, materials, indications for use, and non-clinical mechanical testing to show that it is as safe and effective as existing predicate devices.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present because it's not a required component of a 510(k) for this type of device:

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

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for a 510(k) is the demonstration of "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance (Non-Clinical): Mechanical testing was conducted. The document states:
  • ASTM F2077: Static and Dynamic Compression, Static and Dynamic Compression Shear tests were performed.
  • ASTM F2267: Subsidence test was performed.
  • ASTM F543-13: Axial Pullout test was performed.
  • Anti-Screw Backout Expulsion: A test was performed.
  • Bacterial endotoxin testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
  • Specific performance metrics (e.g., precise load limits, displacement values, or pass/fail thresholds) are NOT detailed in this summary. The FDA review process would have evaluated the raw data and compared it against established standards or predicate device performance, but these specific numbers are not public in this summary document. The "Conclusion" states: "Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices."

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

• Not Applicable in the traditional sense for this type of device: For a mechanical device like an interbody fusion device, "test set" typically refers to the samples of the device itself (e.g., a certain number of devices tested for mechanical properties). The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The tests were conducted according to ASTM and ANSI/AAMI standards, likely in a laboratory setting. Country of origin for data is not specified, but the submitter is Spineology Inc. in Saint Paul, Minnesota, USA. The testing is prospective in the sense that the manufacturer specifically conducted these tests for this submission.

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: This is not a diagnostic device or an AI/ML algorithm that requires expert ground truth labeling. Mechanical properties are measured objectively by instrumentation in a laboratory, not by expert opinion.

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

• Not applicable: No expert adjudication is involved in evaluating the primary performance of this mechanical 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 a mechanical implantable device, not a diagnostic imaging or AI-assisted device. No human reader studies (with or without AI assistance) are relevant or mentioned.

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

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

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

• Mechanical Standards: The "ground truth" for the mechanical testing is adherence to established industry standards (ASTM, ANSI/AAMI) for biocompatibility, sterility, and mechanical strength, often compared against performance data from predicate devices. Clinical "outcomes data" is generally part of a PMA (Premarket Approval) process, not a 510(k), unless specific new safety/effectiveness questions arise.

8. The sample size for the training set:

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

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

• Not applicable: As above, no training set is involved.

Summary of what the document does provide:

• Device Name: Rampart One Lumbar Interbody Fusion Device
• Intended Use: Intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment.
• Materials: PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), tantalum (radiopaque markers).
• Mechanisms of Action: Integrated fixation with titanium alloy screws, hollow core for bone graft.
• Non-Clinical Testing Conducted: Mechanical tests (Static/Dynamic Compression/Shear, Subsidence, Axial Pullout, Anti-Screw Backout Expulsion) and Bacterial Endotoxin Testing, all performed according to recognized standards.
• Predicate Devices: Several predicate devices are listed, including other Spineology Rampart devices and devices from Cutting Edge Spine, Synthes Spine, and Biomet Spine. The new device is compared to these predicates to demonstrate substantial equivalence in intended use, indications for use, fundamental scientific technology, principle of operation, biological safety, base materials, and size offering.

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