(124 days)
The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted via a transforaminal (TLIF) or posterior (PLIF) approach, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.
Here's a breakdown of the acceptance criteria and study information for the FlareHawk Interbody Fusion System, based on the provided FDA 510(k) summary:
This device is an interbody fusion system, and the provided document is an FDA 510(k) summary. For this type of device, the "acceptance criteria" are typically related to mechanical performance and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than a diagnostic performance metric (like sensitivity/specificity) seen in AI/imaging devices. The "study" refers to non-clinical bench testing. There is no mention of an AI component or clinical studies in this submission document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Standard / Characteristic | Acceptance Criteria (Implicit from "in accordance with" and "meets") | Reported Device Performance (Implicitly, the device met these criteria for substantial equivalence) |
|---|---|---|---|
| Coating Characterization & Integrity | Stereological Assessment | In accordance with ASTM F1854 | Device met requirements per ASTM F1854 |
| Static Shear Strength | In accordance with ASTM F1044 | Device met requirements per ASTM F1044 | |
| Static Tensile Strength | In accordance with ASTM F1147 | Device met requirements per ASTM F1147 | |
| Abrasion Resistance | In accordance with ASTM F1978 | Device met requirements per ASTM F1978 | |
| Wear Debris & Particle Characterization | In accordance with ASTM F1877 | Device met requirements per ASTM F1877 | |
| Finished Device Mechanical Testing | Static Axial Compression | In accordance with ASTM F2077 | Device met requirements per ASTM F2077 |
| Dynamic Axial Compression | In accordance with ASTM F2077 | Device met requirements per ASTM F2077 | |
| Static Compression Shear | In accordance with ASTM F2077 | Device met requirements per ASTM F2077 | |
| Dynamic Compression Shear | In accordance with ASTM F2077 | Device met requirements per ASTM F2077 | |
| Biocompatibility | Cytotoxicity Testing | In accordance with ISO 10993-5 | Device met requirements per ISO 10993-5 |
| Biocompatibility Assessment | In accordance with ISO 10993-1 | Device met requirements per ISO 10993-1 |
Comment: The document states that integrity implants has conducted these tests "in support of this premarket notification submission" and concludes that the device "demonstrates substantial equivalence to legally marketed predicate devices, and any differences... do not impact the safety and effectiveness." This implicitly means the device met the acceptance criteria for these tests. Specific numerical performance results are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of devices or test repetitions. For bench testing, samples are typically representatives of the manufacturing process.
- Data Provenance: The tests were non-clinical bench performance tests, meaning they were conducted in a lab environment on the device itself, not on patient data or in a clinical setting. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the usual sense.
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 medical device for implantation, and the "ground truth" for its performance is established through adherence to engineering standards (ASTM, ISO) and laboratory measurements, not through expert human interpretation of data for diagnostic purposes.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts interpreting data. This document describes bench testing against engineering standards.
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 not an AI-assisted diagnostic device, nor does the submission mention an AI component. It is an implantable intervertebral fusion system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- For mechanical testing: Engineering standards (ASTM F2077, F1044, F1147, F1978, F1854, F1877) and laboratory measurements of physical properties.
- For biocompatibility: ISO standards (ISO 10993-1, ISO 10993-5) and laboratory biological assessments (e.g., cytotoxicity assays).
8. The sample size for the training set
- Not applicable. This refers to an implantable medical device, not a machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned or relevant to this device type.
§ 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.