Search Results

The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.

The Crius PEEK Suture Anchor System is a soft-tissue to bone fixation device, provided preloaded on a disposable inserter. Crius PEEK Suture Anchor System includes four types Thread-Fix Anchor, Thread-Fix Ultra Anchor,Helicoil Anchor and Pile Anchor.The device is available in varying profile diameters. The system consists of a suture anchor, suture(except for Pile Anchor ), and insertion handle and insertion shaft) and is a sterile,single use device. The anchor body is manufactured from Polyetheretherketone(PEEK).The suture is made from ultra high molecular weight polyethylene(UHMWPE) available in white and blue/white colors. The blue dye used in the suture is Chromium-cobalt-aluminum oxide in accordance with 21 CFR 73.1015 regulations. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture. The insertion shaft is made from 304 stainless steel compliant with ISO 7153-1 and 630 stainless steel compliant with ISO 16061. The surgical instruments are provided non-sterile and shall be sterilized by the end user.

The provided document is a 510(k) premarket notification for a medical device called the "Crius PEEK Suture Anchor System." This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about the performance or acceptance criteria of an AI/ML device.

Therefore, I cannot provide a detailed answer to your request. The document describes a traditional medical device (suture anchors) and its physical and mechanical performance testing, not the performance of an AI/ML system.

However, I can extract the information that is present about the traditional device's performance testing:

Performance Data for Crius PEEK Suture Anchor System (Traditional Medical Device)

The performance data included in the document relates to mechanical testing of the suture anchors, not an AI/ML model.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Acceptance criteria were based on similar sized predicate suture anchor devices and the results of the performance testing showed the subject device to have substantially equivalent performance compared to the predicate device."
Specific numerical acceptance criteria are not provided in this summary.

Ask a specific question about this device

The Gemini Cervical Fusion Cage System is indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one levels from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Gemini Cervical Fusion Cage System requires additional supplemental fixation cleared for the cervical spine. The Gemini Cervical Fusion Cage System is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

The Gemini Cervical Fusion Cage Systeme is an anterior cervical interbody device consisting of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an open, anterior approach.

The Gemini Cervical Fusion Cage System is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The radiolucent PEEK-OPTIMA®material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ISO13782 to permit verification of position. The Gemini Cervical Fusion Cage System is provided sterile via gamma irradiation for single use.Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is an FDA 510(k) clearance letter for a medical device called the "Gemini Cervical Fusion Cage System," which is an intervertebral body fusion device. The clearance is based on the substantial equivalence to a predicate device, focusing on:

• Mechanical performance: Verified through testing per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, compression shear, torsional testing, and subsidence testing. The document states that "Test results meet the acceptance criteria described in ISO 23089-2 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices."
• Material: PEEK-OPTIMA® LT1 with tantalum markers, which is a common material for such implants.
• Design features: Graft windows, serrations, and comparable dimensions to the predicate.
• Sterilization: Gamma irradiation for single use.
• Intended Use and Indications for Use: Defined for anterior cervical interbody fusion procedures for cervical disc disease.

There is no mention of an AI/ML component, diagnostic performance, human readers, ground truth establishment, or any of the other criteria you listed that would be relevant to an AI/ML-driven device evaluation (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications for ground truth).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.

Ask a specific question about this device

The Gemini Medical Cage System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Gemini Medical Cage System is manufactured from a biocompatible polymer (Polyetheretherketone (PEEK)) material embedded with radiopaque tantalum marker pins, which allow the surgeon to radiographically determine the position of the implant, both intraoperatively and postoperatively. The System consists of PEEK lumbar cages of various shape and size, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The top surface of the cages have anatomical design, parallel design and wedge-shaped design respectively to adapt various vertebrae anatomical scenarios. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages are sterile provided and for single use. There are six models to accommodate different types of superior and inferior end plates depending on their technical design and shape, LF-I, LF-II, LF-III, LF-IV, LF-V and LF-VI. LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II has flat top and bottom tooth surface, LF-III and LF-V have flat or wedge-shaped surface. LF-III, LF-IV and LF-V cages have a convex angle.

Here's an analysis of the provided text regarding the Gemini Medical Cage System, structured to answer your questions.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than comprehensive clinical trials proving efficacy de novo. Therefore, many of your questions about AI study design (like ground truth, expert adjudication, MRMC studies, training/test sets) are not applicable to this type of traditional medical device clearance for an orthopedic implant.

This document focuses on demonstrating that the Gemini Medical Cage System performs equivalently to existing devices through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative way for each test in a pass/fail format with specific thresholds. Instead, it lists the bench tests performed according to ASTM standards and implies that the device met the requirements of these standards to demonstrate substantial equivalence to predicate devices. The "reported device performance" is the successful completion of these tests, indicating compliance with the relevant ASTM standards for intervertebral body fusion devices.

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

• Sample Size: The document does not specify the exact number of devices tested for each bench test. For mechanical bench testing, the sample size is determined by the specific ASTM standard and statistical requirements for device qualification, but these details are not provided in this 510(k) summary.
• Data Provenance: The data is from non-clinical bench testing performed on the devices themselves. There is no patient data involved in this type of submission for this device. The tests were likely conducted by or for ZheJiang Decans Medical Devices Co., Ltd., which is based in China.

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

• Not Applicable. This is a mechanical orthopedic implant, not an AI/software device that requires expert-established ground truth from medical images or clinical data. The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ASTM standards for mechanical properties).

4. Adjudication Method for the Test Set

• Not Applicable. As this is not a study involving human interpretation or subjective assessments, there is no adjudication method in the traditional sense. The "adjudication" is whether the device passed the objective criteria of the specified ASTM bench tests.

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 physical medical device (intervertebral body fusion device), not an AI software. Therefore, no MRMC studies or AI-assisted performance evaluations were conducted or are relevant.

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 or software.

7. The Type of Ground Truth Used

• Engineering Standards and Biocompatibility Testing: The "ground truth" for this device's performance demonstration lies in its compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267) and the biocompatibility of its materials (PEEK and tantalum markers). The goal is to show that the device is mechanically and biologically equivalent to predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI software requiring a training set.

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

• Not Applicable. This is a physical medical device, not an AI software requiring a training set.

Ask a specific question about this device