(265 days)
The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervical interbody device consisting of a titanium alloy (Ti-6Al-4V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al-4V ELI) anchors per ASTM F136, and a titanium alloy (Ti-6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and are offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal bladed anchors that lock on deployment and provide additional fixation.
The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., an anterior plate, posterior pedicle screws) may be needed.
This document describes the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. Therefore, the "acceptance criteria" and "device performance" are primarily related to biomechanical testing and material properties, rather than diagnostic accuracy as would be found in an AI/ML device submission.
Here's the information as requested, interpreted in the context of this orthopedic implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Purpose | Device Performance |
|---|---|---|
| Static Subsidence (ASTM F2267-04) | Evaluates how much the implant sinks into the bone under static load. | Results demonstrate equivalence to predicate devices. |
| Expulsion (Standard N/A) | Assesses the resistance of the implant to being dislodged from the intervertebral space. | Results demonstrate equivalence to predicate devices. |
| Dynamic Axial Compression (ASTM F2077-18) | Measures the fatigue strength of the implant under cyclic compressive loads. | Results demonstrate equivalence to predicate devices. |
| Dynamic Compression-Shear (ASTM F2077-18) | Measures the fatigue strength of the implant under combined compressive and shear loads. | Results demonstrate equivalence to predicate devices. |
| Dynamic Torsion (ASTM F2077-18) | Measures the fatigue strength of the implant under twisting loads. | Results demonstrate equivalence to predicate devices. |
| ROM Cadaveric Testing | Compares the range of motion provided by the subject device versus a previously cleared standalone device in a cadaveric model. | The results demonstrate the subject device is substantially equivalent to the predicate devices in stabilization performance. |
| Sterilization Assurance Level (SAL) | Confirms sterile processing reaches a SAL of 10^-6. | Minimum radiation dose of 25kGy was sufficient to meet a SAL of 10^-6. |
| Package System Integrity | Ensures packaging remains intact and maintains a hermetic barrier after sterilization and distribution. | Package system remained intact while also maintaining the hermetic barrier. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Biomechanical Testing (Implants): Not explicitly stated how many individual implants were tested for each biomechanical test (Static Subsidence, Dynamic Axial Compression, etc.). However, these tests are generally conducted on a sufficient number of samples (e.g., 5-10 per test condition) to establish statistical significance according to the ASTM standards.
- Sample Size for Cadaveric Testing: Not explicitly stated how many cadaveric spines were used.
- Data Provenance: The tests are non-clinical (laboratory and cadaveric studies). This is retrospective data collected for the purpose of this submission.
- Country of Origin: Not specified, but generally, such testing is conducted in accredited labs, often within the US or by international labs recognized by the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable in the context of an orthopedic implant biomechanical study. "Ground truth" in this scenario is established by the standardized methods outlined in ASTM specifications and accepted engineering principles, rather than expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" (i.e., test results meeting predefined criteria) is determined directly by the physical measurements from standardized biomechanical tests, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/ML diagnostic devices to assess how the AI assists human readers. This submission is for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical implant, not an algorithm. The "standalone" performance here refers to the biomechanical performance of the implant itself, which is what the non-clinical testing evaluates (without human intervention in the device's function).
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Standardized Biomechanical Test Results: Adherence to established ASTM standards (F2267-04, F2077-18) defines the "ground truth" for mechanical properties (e.g., strength, fatigue resistance).
- Cadaveric Biomechanical Measurements: Measurements of range of motion and stability in a cadaveric model serve as "ground truth" for the device's functional performance in a relevant anatomical context.
- Sterilization Validation: Meeting a pre-defined Sterility Assurance Level (SAL) of 10^-6 is the "ground truth" for sterility.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device. The device's design and materials are based on established engineering principles and prior predicate device data, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.