Search Results

The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

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

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

Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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

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

Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

Ask a specific question about this device

Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Mini and Micro Fragments Reconstruction System – GMReis is composed of plates and screws. The bone plates are made from commercially pure titanium alloy (Ti-4Al-6V) and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 2.0 mm, and the screws range in diameter from 1.5 to 2.7 mm. They are available on different sizes and shapes, according the implantation site and the extension of the fracture.

Mini and Micro Fragments Reconstruction System – GMReis are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according the recommendations provided in the Instructions for Use.

In order to promote a correct placement of the plates and screws, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drills, drill guides, cutting pliers, reamers, screwdrivers, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the implants and promote the success of the procedure.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in osteosyntheses procedures.

This document is a 510(k) premarket notification for the "Mini and Micro Fragments Reconstruction System - GMReis". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for biocompatibility and mechanical properties. It does not provide a table with specific acceptance criteria and detailed reported device performance values in a quantifiable manner (e.g., specific tensile strength values or fatigue cycles). Instead, it states that the devices meet the requirements of established standards.

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

The document does not specify the exact sample sizes used for the biocompatibility or mechanical testing. It mentions that "tests required" and "mechanical testing" were performed according to the listed standards, implying that sufficient samples were tested to meet the requirements of those standards.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the manufacturer is GM dos Reis Indústria e Comércio Ltda, located in Campinas, São Paulo, Brazil. The testing would have been conducted by or for this manufacturer.

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

This information is not applicable to this type of device. The "Mini and Micro Fragments Reconstruction System - GMReis" is a metallic bone fixation appliance, not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The performance is assessed through standardized physical and mechanical tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple human readers, not for mechanical testing of orthopedic implants.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI-assisted diagnostic tool for which human reader performance would be evaluated with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone study of an algorithm without human-in-the-loop performance was not done. This device is a physical hardware product, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established through adherence to recognized international standards for biocompatibility (ISO 10993-1) and mechanical properties (ASTM F382, ASTM F543) and sterilization (ISO 17665-1, ISO 17665-2). The "truth" is that the device performs as expected under these standardized test conditions. It's not a diagnostic "ground truth" derived from expert consensus or pathology.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a software or AI model that requires a "training set."

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

Not applicable. As this is not a software or AI model, there is no training set or associated ground truth establishment method.

Ask a specific question about this device

The Pedimax II - Pedicle Screw Spinal System is indicated for posterior, non-cervical fixation in skeletally mature patients. It is intended to be used as an adjunct to fusion using autograft. The device is indicated for the treatment of the following acute and chronic instabilities or deformittes: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Pedimax II - Pedicular Screw Spinal System." This document primarily deals with the regulatory clearance of a physical medical device (spinal pedicle screws) rather than an AI/software-as-a-medical-device (SaMD) or AI-assisted diagnostic device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-based device (e.g., ground truth, sample size for test/training sets, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.

The document discusses:

• Device Name: Pedimax II - Pedicular Screw Spinal System
• Regulation Number and Name: 21 CFR 888.3070, Thoracolumbosacral pedicle screw system
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion using autograft for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
• Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The "study" referenced in the prompt (proving the device meets acceptance criteria) for a physical medical device like this would typically involve:

• Mechanical Testing: Fatigue testing, static compression/tension, torsion, pull-out strength, etc., to ensure the device meets specified mechanical performance attributes.
• Biocompatibility Testing: According to ISO 10993 standards, to ensure the materials are safe for implantation.
• Sterilization Validation: To ensure the device can be consistently sterilized.

However, the 510(k) clearance letter itself does not contain the details of these studies or their specific acceptance criteria and results. It only states that the FDA has reviewed the submission and found the device to be substantially equivalent, implying that the manufacturer provided sufficient data (including performance testing) to support the claim.

Ask a specific question about this device