(170 days)
The Integrity-SI™ Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Integrity-SI™ Fusion System consists of partially and fully threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per ASTM F136) implants designed to be inserted across sacroiliac joint to provide stability for joint arthrodesis. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in and partially and fully threaded versions in lengths ranging from 40-110mm, in 5mm increments. All screw sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary screws are offered from lengths of 30 - 70 mm, in 5mm increments. All implants are provided sterile and are individually packaged. The 6.5 mm screws are not for use without the subject 10 mm or 12 mm screws.
The provided document describes the mechanical testing and substantial equivalence determination for the "Integrity-SI™ Fusion System". This is a medical device (sacroiliac joint fixation fastener) and not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, ground truth, and training set details are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance related to the mechanical testing described in the document.
Acceptance Criteria and Reported Device Performance
The document states that "Testing was performed for the Integrity-SI™ Fusion System and demonstrated substantially equivalent performance to the identified predicates." The acceptance criterion for this device appears to be demonstrating substantial equivalence in mechanical performance to the predicate devices and the ability to withstand expected loading without failure.
The document lists the following mechanical tests performed and the general findings:
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Torsional strength/breaking angle | Substantially equivalent to predicates; capable of withstanding expected loading. | Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. |
| Insertion/removal torque | Substantially equivalent to predicates; capable of withstanding expected loading. | Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. |
| Pullout force | Substantially equivalent to predicates; capable of withstanding expected loading. | Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. |
| Static Bending Strength | Substantially equivalent to predicates; capable of withstanding expected loading. | Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. |
| Fatigue Bending Strength | Substantially equivalent to predicates; capable of withstanding expected loading. | Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. |
| Cadaveric testing (surgical technique) | Device can be safely implanted using the surgical technique. | Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique. |
N/A for AI/ML Specific Questions:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a mechanical medical device, not an AI/ML system. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical tests would be defined by the specifications and measurement techniques outlined in the referenced ASTM standards (e.g., ASTM F543-13e1, ASTM F2193-14).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.