(136 days)
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).
Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.
The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Cage System," an intervertebral body fusion device.
Crucially, this document explicitly states: "No clinical performance data is included in this submission."
Therefore, I cannot provide information regarding acceptance criteria or a study proving the device meets those criteria, as no such study or data is presented in this submission.
The 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and material comparisons.
Here's what I can extract based on your request, as much as possible given the lack of clinical data:
1. A table of acceptance criteria and the reported device performance
Since no clinical studies or clinical performance data were provided, there are no predefined clinical acceptance criteria or reported clinical device performance to list.
The non-clinical performance data section mentions that the device met design specifications and conformed to specific ASTM standards:
- ASTM F2077 Test Methods For Intervertebral Body Fusion Devices
- ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
The tests conducted under these standards include:
- Static axial compression test
- Static compression shear test
- Dynamic axial compression test
- Dynamic compression shear test
- Subsidence Test
However, the document does not specify the acceptance criteria (e.g., minimum load, maximum deformation) for these non-clinical tests nor the exact reported performance values of the Double Medical Cage System against those criteria. It only states that the device "met all design specifications" and "conforms" to these standards.
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, as no clinical test set data is provided. For the non-clinical tests, the report does not specify the number of units tested. The data would be from laboratory testing, presumably performed in China, given the submitter's location.
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, as no clinical test set data is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set data is provided.
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 intervertebral body fusion system, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were performed or reported in this submission. For the non-clinical tests, the "ground truth" would be the expected mechanical properties and performance defined by the ASTM standards and the device's design specifications.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no mention of 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.