(260 days)
The ENDO-FUSE® Intra-Osseous Fusion System Rods are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies.)
The ENDO-FUSE® Intra-Osseous Fusion System Beams are indicated for lateral column lengthening and for fusions of any joint in the foot/ankle appropriate for the size of the device, including tarso-metatarsal, metatarsal-cuneiform, calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.
The ENDO-FUSE® Intra-Osseous Fusion System consists of titanium alloy triangular-shaped rods and "barbell" shaped beams intended for surgical implantation within the bone to create fixation. The rods are available in various lengths and diameters and the beams in various widths and lengths. Both rods and beams are roughened with a coating of CP titanium plasma spray which is important for achieving fixation via an interference fit inside the bone.
The ENDO-FUSE® Intra-Osseous Fusion System is supported by several performance tests demonstrating its safety and efficacy.
1. Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Property Testing of Plasma Spray Coating (ASTM F1044, ASTM F1160, ASTM F1147) | "Pre-defined acceptance criteria" (specific numerical values not provided, but generally related to minimum shear and tensile strengths) | All test specimens passed, meeting the pre-defined acceptance criteria for static shear strength, shear fatigue strength, and static tensile strength. |
| Fatigue Testing (Four-point bending) | Ability to withstand cyclic loads at least equivalent to the predicate device. | Subject devices were able to withstand higher cyclic loads than the predicate device, meeting the acceptance criterion. |
| Cadaveric Rod Insertion Testing | "Clinically relevant distraction of the distal bone/fracture fragment" does not occur during rod insertion. | Implantation results after insertion were deemed acceptable per the pre-defined acceptance criteria, indicating no clinically relevant distraction. |
| Cadaveric and Mechanical Beam Distraction Resistance Testing | Effective prevention of distraction of opposing bones after implantation, at least equivalent to the predicate device. | The subject device experienced greater distraction resistance than the predicate, meeting the acceptance criterion. |
2. Sample Size and Data Provenance
- Plasma Spray Coating Tests: Performed on "worst-case coated test coupons." The exact number of coupons or samples is not specified.
- Fatigue Testing: Conducted on "worst-case subject devices." The exact number of devices tested is not specified.
- Cadaveric Rod Insertion Testing: Performed using cadaveric models. The number of cadavers or limbs used is not specified.
- Cadaveric and Mechanical Beam Distraction Resistance Testing: Performed using cadaveric models and mechanical testing. The number of cadavers/limbs and mechanical test samples is not specified.
The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated, but the testing appears to be primarily laboratory-based and cadaveric studies conducted by the manufacturer, Wright Medical Technology, Inc., located in Arlington, TN, USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the performance tests. The tests are primarily mechanical and cadaveric studies and rely on objective measurements and predefined engineering criteria rather than expert clinical assessment of outcomes.
4. Adjudication Method
No adjudication method is mentioned, as the studies are mechanical and cadaveric engineering tests, not clinical trials requiring expert adjudication of patient outcomes or image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases with and without AI assistance and is irrelevant for a bone fixation system.
6. Standalone Performance (Algorithm Only)
Not applicable. The ENDO-FUSE® Intra-Osseous Fusion System is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on:
- Established engineering standards: ASTM F1044, ASTM F1160, and ASTM F1147 for material properties.
- Comparative mechanical performance: Against an FDA-cleared predicate device.
- Physical observation and measurement: In cadaveric models for rod insertion and distraction resistance.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How Ground Truth for Training Set was Established
Not applicable. As there is no training set for a physical device, no ground truth was established for it.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.