(310 days)
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
The provided text describes the 510(k) summary for Sintea Plustek's PLIF Lite and TLIF Lite Interbody Fusion system, which is a medical device for spinal fusion. This specific document focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical performance and design, rather than conducting a clinical study to establish new performance criteria. Therefore, the information requested for a clinical study assessing device performance against acceptance criteria is largely not applicable in this context.
Here's an analysis based on the provided text, highlighting what is available and what is not:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static axial compression
- Dynamic axial compression
- Static compression shear
- Dynamic compression shear
- Static torsion
- Subsidence
- Expulsion | "Test results demonstrate that the PLIF Lite and TLIF Lite devices are substantially equivalent to the predicate devices" in regards to "Mechanical testing". |
| Material: PEEK and Titanium alloy (for markers) | "Substantially equivalent to the predicate devices" in regards to "Materials". |
| Dimensions: Variety of heights and lengths | "Substantially equivalent to the predicate devices" in regards to "Dimensions". |
| Function: Facilitate fusion with autograft bone; use with supplemental fixation | "Substantially equivalent to the predicate devices" in regards to "Function". |
| Indications for Use: Intervertebral body fusion at L2-S1 for DDD with up to Grade 1 spondylolisthesis in skeletally mature patients after 6 months non-operative treatment. | "Substantially equivalent to the predicate devices" in regards to "Indications for Use". |
Explanation: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device performs as well as, or better than, the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The core "study" here is the performance testing conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267) to show mechanical equivalence.
Study Details (as far as applicable to a 510(k) for substantial equivalence)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document refers to "Performance Testing" according to ASTM F2077 and ASTM F2267, which are mechanical testing standards. These standards typically involve a specific number of samples (e.g., 5 or 6 per test condition) of the device to be tested. The exact number of samples is not explicitly stated in this summary.
- Data provenance: Not specified, but generally, such bench testing is conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. It is prospective in the sense that the tests are planned and executed to evaluate the new device. Country of origin is Miami, FL, implying the sponsor is U.S.-based.
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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. This device's evaluation is based on mechanical testing, not clinical or diagnostic performance that would require expert adjudication of "ground truth" for patient data. The "ground truth" for mechanical testing is established by the test procedures and measurements themselves, compared against the predicate device's performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical testing. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation (e.g., image reading).
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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 medical implant device, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical performance testing, the "ground truth" is derived from the established mechanical properties and performance of the predicate devices as demonstrated through their own testing and regulatory clearance, and the adherence to the relevant ASTM standards for intervertebral body fusion devices. The goal is to show the new device meets or exceeds these established benchmarks.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical performance testing for a spinal implant device. This terminology relates to machine learning or AI algorithm development.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
In summary: The provided document is a 510(k) submission establishing substantial equivalence for a spinal implant. This process primarily relies on benchtop mechanical testing against recognized industry standards (ASTM F2077, ASTM F2267) and comparison to predicate devices, rather than clinical trials involving patient data, human reader performance, or AI algorithms. Therefore, many of the requested details about study design and ground truth establishment, which are typical for clinical performance studies, are not present or applicable.
§ 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.