(91 days)
The CRESCENT™ Spinal System is indicated for interbody fusion 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 spondylolishtesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The CRESCENT™ Spinal System consists of PEEK cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The devices are manufactured from medical grade PEEK-Optima LT1 (polyetheretherketone) and contains tantalum markers. These devices also contain Tantalum markers used for imaging purposes.
The provided text describes a 510(k) premarket notification for the CRESCENT™ Spinal System, specifically for additional sizes of implants and instruments. As such, it focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study that establishes specific acceptance criteria and performance metrics in the way a novel device might.
Therefore, much of the requested information regarding acceptance criteria experiments, sample sizes, expert involvement, and ground truth establishment is not available in this document because the submission's goal is to show similarity to existing approved devices, not to establish new performance benchmarks through de novo clinical trials.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria with corresponding performance results in a table format. The performance data presented are primarily focused on demonstrating that the new sizes do not negatively impact safety and effectiveness compared to the predicate devices.
| Acceptance Criterion (Inferred from text) | Reported Device Performance (Summary from text) |
|---|---|
| Mechanical Strength & Expulsion Resistance (for new implant sizes) | "The mechanical strength and the expulsion resistance have been documented in a confirmatory engineering rationale." The document asserts that "the subject 40mm and 45mm longer PEEK implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device." This implies that the performance for these aspects meets or exceeds that of the predicate, or at least falls within acceptable limits established for the predicate. |
| Biocompatibility | "Identical to the primary predicate devices the implants in the subject Crescent™ Spinal System are provided in sterile form and are made using medical grade PEEK-Optima LT1 (polyetheretherketone) and contain Tantalum markers for imaging. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared in predicate... PEEK-Optima LT1 (polyetheretherketone) and stainless steel material used for the subject CRESCENT Spinal System implants and instruments have a long clinical history of safe and effective use in similar commercially available medical devices." Conclusion: "no additional biocompatibility testing is required." This indicates acceptance if the materials are the same as previously cleared, safe, and effective predicates. |
| Non-Pyrogenicity (Endotoxin Testing) | "Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Transfusion and Infusion Assemblies and Similar Medical Devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for mechanical or endotoxin testing. For biocompatibility, reliance on "long clinical history" suggests a large, accumulated dataset from prior usage of the materials, but no specific number of devices or patients is provided for this submission. The mechanical testing refers to an "engineering rationale," which typically involves bench testing, not patient data in the context of a 510(k) for size additions.
- Data Provenance: The document does not specify the country of origin for the data. The tests (mechanical, endotoxin) are likely conducted in a controlled lab environment. The "long clinical history" of materials implies data collected globally over time for various similar devices. The study type is for substantial equivalence for new sizes/instruments, not a de novo clinical study.
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. This type of information is typically for diagnostic AI algorithms or clinical trials with subjective endpoints. This submission is for an intervertebral body fusion device (implant) and focuses on material science and mechanical performance benchmarks against existing predicates, not human expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical trials or studies involving expert review of outcomes or images. The performance data presented here are from engineering and laboratory 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. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, potentially assisted by AI. This document is for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing: Ground truth is against established engineering standards (ASTM F2077) and the performance of the predicate devices.
- Biocompatibility: Ground truth is the historical safety and effectiveness of the existing materials (PEEK-Optima LT1, Tantalum, stainless steel).
- Non-Pyrogenicity: Ground truth is established laboratory limits for endotoxins (e.g., 20 EU/device) as defined by standards like ANSI/AAMI ST72 and USP .
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" in this context refers to the development and testing of the engineering design of the implant.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set." The understanding of material properties and mechanical performance would have been established through extensive prior research, testing, and clinical use of similar devices over many years.
§ 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.