(90 days)
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Construx Mini PEEK System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical Ascent™ or Ascent LETM POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative r attention masterial with the Construx Mini PEEK System in the cervical spine.
The Construx Mini PEEK device is used singly and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the Construx Mini When used as i Parliated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised replacement of tumors, to achieve anterior decompression of the spinal cord and for the treatment of tumors, to active an arrest aponed vertebral body. The Construx Mini neural issues, and to restore the freigen in a fractures of the thoracic and lumbar spine.
The Construx Mini PEEK System is designed to restore the biomechanical integrity of the The Collistian Minn I EEIN Bysterior spinal column even in the absence of fusion for a prolonged amenor, inidate, and posterier epinal se is intended to be used with autograft or allograft.
The Construx Mini PEEK System is intended for use with internal fixation. The The Collstux Internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
The Construx Mini PEEK Spacer System components consist of:
- A PEEK Spacer 2) cp Titanium Markers
The Construx Mini Spacer System is a Cervical IBFD device that is implanted using anterior surgical approach with the intention is to achieve intervertebral spinal fusion. In addition, the Construx Mini is intended to contain autologous bone graft to facilitate intervertebral fusion. The Construx Mini performance data, in combination with a dimensional comparison to predicate devices and testing, has been used to demonstrate substantial equivalence with devices that are cleared for both Cervical IBFD and Partial VBR indications.
Here's a breakdown of the acceptance criteria and the study information for the Blackstone Construx Mini PEEK Spacer System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression | Meets ASTM F2077-03 standards for static compression of IBFDs. | Performed in accordance with ASTM F2077-03. The submission states that "The Construx Mini performance data... has been used to demonstrate substantial equivalence." This implies the results met or exceeded the requirements of the ASTM standard. |
| Dynamic Compression | Meets ASTM F2077-03 standards for dynamic compression of IBFDs. | Performed in accordance with ASTM F2077-03. As above, performance data contributed to substantial equivalence, indicating satisfactory results. |
| Static Torsion | Meets ASTM F2077-03 standards for static torsion of IBFDs. | Performed in accordance with ASTM F2077-03. Performance data supported substantial equivalence. |
| Dynamic Torsion | Meets ASTM F2077-03 standards for dynamic torsion of IBFDs. | Performed in accordance with ASTM F2077-03. Performance data supported substantial equivalence. |
| Subsidence | Meets ASTM F2267-04 standards for subsidence of IBFDs. | Performed in accordance with ASTM F2267-04. Performance data contributed to substantial equivalence. |
| Substantial Equiv. | Device is substantially equivalent to predicate devices in: intended use, indications for use, technological characteristics, and principles of operation, with no new issues of safety or effectiveness. | The Construx Mini Spacer System has been demonstrated to be substantially equivalent to predicate devices in these aspects. |
Explanation of Acceptance Criteria (Implied):
The document implicitly states that the acceptance criteria for the mechanical tests (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence) were adherence to the specified ASTM standards (ASTM F2077-03 and ASTM F2267-04). For a 510(k) submission, meeting these recognized standards is a primary way to demonstrate safety and effectiveness for mechanical performance. The ultimate acceptance criterion is substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the mechanical tests. However, these types of tests (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence) typically involve a statistically relevant number of physical devices or representative constructs as per the ASTM standards.
- Data Provenance: The data is from mechanical testing of the device components. It is not patient or clinical data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" do not apply in the context of this specific regulatory submission, which focuses on device design and mechanical performance for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "test set" here refers to physical devices undergoing mechanical engineering tests, not a clinical dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods are relevant for clinical studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) submission is for a medical device (spinal implant), and the provided text describes mechanical testing and a comparison to predicate devices, not a clinical study involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical spinal implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by engineering standards and direct measurement of mechanical properties. The performance of the Construx Mini PEEK Spacer System was evaluated against the requirements outlined in ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Device Static and Dynamic Cyclic Compression Shear and Torsion Testing) and ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is verification and validation of the physical device's mechanical properties.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.