(68 days)
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.
| Test Type | Standard Applied | Reported Device Performance |
|---|---|---|
| Static Axial Compression Testing | ASTM F2077 | Performance-bench test completed, demonstrating substantial equivalence. |
| Dynamic Axial Compression Testing | ASTM F2077 | Performance-bench test completed, demonstrating substantial equivalence. |
| Static Compression Shear Testing | ASTM F2077 | Performance-bench test completed, demonstrating substantial equivalence. |
| Dynamic Compression Shear Testing | ASTM F2077 | Performance-bench test completed, demonstrating substantial equivalence. |
| Subsidence Test | ASTM F2267 | Performance-bench test completed, demonstrating substantial equivalence. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.