(367 days)
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
Here's an analysis of the provided 510(k) summary regarding the Transcorp ACIF System, focusing on acceptance criteria and supporting studies:
Transcorp ACIF System: Acceptance Criteria and Supporting Studies
This 510(k) summary focuses on "substantial equivalence" to predicate devices rather than clinical efficacy studies often seen with AI/software devices. The acceptance criteria and supporting studies mentioned are primarily related to non-clinical performance testing of a physical implant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Axial Compression (per ASTM F2077-03) | Performed and deemed acceptable |
| Dynamic Axial Compression (per ASTM F2077-03) | Performed and deemed acceptable | |
| Static Compression Shear (per ASTM F2077-03) | Performed and deemed acceptable | |
| Dynamic Compression Shear (per ASTM F2077-03) | Performed and deemed acceptable | |
| Static Torsion (per ASTM F2077-03) | Performed and deemed acceptable | |
| Dynamic Torsion (per ASTM F2077-03) | Performed and deemed acceptable | |
| Subsidence Resistance | Subsidence Testing (per ASTM F2267-04) | Performed and deemed acceptable |
| Biocompatibility/Wear | Wear Testing Analysis (Particulate Generation via ASTM F1877-05) | Performed; wear debris collected and analyzed, deemed acceptable |
Note: The document only states that these tests were "performed" and that the results "demonstrated substantial equivalence" to predicate devices. It does not provide specific numerical outcomes or detailed acceptance ranges (e.g., maximum deflection, fatigue life cycles, subsidence amount, wear particulate size/quantity). The general statement "deemed acceptable" is inferred from the FDA's clearance based on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For mechanical and wear testing of physical implants, a representative sample size of the manufactured device is typically used, often following industry standards for testing implantable devices (e.g., 5-10 samples per test condition).
- Data Provenance: The tests are explicitly stated as "non-clinical performance testing." This implies they were conducted in a laboratory setting, likely on manufactured prototypes or production units of the device. There is no mention of human-derived data, country of origin related to patient data, or retrospective/prospective studies as these are not relevant for this type of medical device's 510(k) clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For this type of physical device (intervertebral body fusion device) undergoing mechanical and wear testing, "ground truth" is established by adherence to international standards (e.g., ASTM F2077-03, ASTM F2267-04, ASTM F1877-05) and internal engineering specifications, not by expert consensus on clinical data. The performance is objectively measured against physical criteria.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements in expert opinion when establishing ground truth, typically in image analysis or clinical endpoint studies. Since this device underwent non-clinical laboratory testing, such an adjudication method is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned and would be irrelevant for a physical intervertebral body fusion device undergoing mechanical and wear testing. MRMC studies are typically performed for diagnostic imaging devices or AI-powered clinical decision support tools to evaluate human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a physical implant, not an algorithm or software device. The concept of "standalone algorithm performance" does not apply here. The device's performance is its inherent mechanical and material properties.
7. Type of Ground Truth Used
- Objective Engineering Standards and Physical Measurements. The "ground truth" for the performance tests relies on:
- ASTM Standards: F2077-03 (Static and Dynamic Axial Compression, Compression Shear, Torsion), F2267-04 (Subsidence), F1877-05 (Wear Debris Analysis).
- Material Specifications: Implant grade PEEK conforming to ASTM F2026-08.
- Comparison to Predicate Devices: Performance is likely compared to the mechanical properties and wear characteristics of the K081730 Alphatec Novel Spinal Spacer System and P980048 BAK/C Vista Cervical Interbody Fusion Device to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
- Not Applicable. This device did not involve any machine learning algorithms, and therefore, there is no "training set" in the context of AI/software. If "training set" refers to samples used during product development or iteration, this information is not provided in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/software involved and thus no "training set," this question is not relevant.
§ 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.