(162 days)
The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. And consist of:
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Cervical interbody fusion Device (Galaxy ACIF cage), which may be implanted as a single device via an anterior approach.
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Lumbar Interbody Fusion Device (Galaxy PLIF, TLIF and ALIF), which may be implanted.
- o Bilaterally via a posterior(PL1F) approach;
- As a single device via a transforaminal(TLIF) approach; 0
- As a Single device via Anterior (ALIF) approach. o
The implants are made of polyether-ether-ketone (PEEK-OPTIMA LTI) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided text describes the "Galaxy (ACIF, PLIF, TLIF and ALIF) Peek Cage" device, an intervertebral body fusion device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (How it performed) |
|---|---|
| Static Axial Compression Testing | Tested according to ASTM 2077, specifically ASTM 2267 |
| Dynamic Axial Compression Testing | Tested according to ASTM 2077, specifically ASTM 2267 |
| Static Torsion Testing | Tested according to ASTM 2077, specifically ASTM 2267 |
| Dynamic Torsion Testing | Tested according to ASTM 2077, specifically ASTM 2267 |
| Static Subsidence Testing under Axial Compression | Tested according to ASTM 2077, specifically ASTM 2267 |
Note: The document states that the devices were tested according to these standards, implying that they met the requirements of these standards. However, it does not provide specific numerical results or explicit pass/fail criteria for each test. The acceptance criterion is implicitly meeting the requirements of the stated ASTM standards.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "The Galaxy (ACIF, PLIF, TLIF and ALJF) Peek Cage devices were tested according to the ASTM 2077...", but does not mention how many devices were tested for each scenario.
- Data provenance: Not explicitly stated. The tests are described as "Performance Data," which typically implies laboratory testing of the device itself, rather than human clinical data. This would be prospective testing on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the provided study. The study described is a mechanical performance study of the device itself, not a study involving human interpretation or diagnosis where expert ground truth would be needed.
4. Adjudication method for the test set:
- This information is not applicable to the provided study. As it's a mechanical performance study, there is no human adjudication involved. The "ground truth" is determined by established engineering test standards (ASTM).
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 information is not applicable to the provided study. The document describes a mechanical performance study of an intervertebral body fusion device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable to the provided study. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- Engineering Standards: The ground truth for the performance data is based on established engineering standards for mechanical testing of spinal implants, specifically ASTM 2077 and ASTM 2267. These standards define the methodology and expected performance characteristics for such devices.
8. The sample size for the training set:
- This information is not applicable. The context is a mechanical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable. As above, it's a mechanical device, not an AI/ML algorithm.
§ 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.