(28 days)
The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
This 510(k) pertains to a medical device, the fiXate Tissue Band, which is an accessory to Spinal Cord Stimulator systems. This type of device does not typically involve AI/ML components or require the extensive validation studies for diagnostic accuracy that are common in AI/ML submissions. Therefore, many of the requested elements (e.g., test set sample size, ground truth establishment, MRMC studies, training set details) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for diagnostic performance, as it is a physical medical device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through functional and safety testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Completed and supports safety and effectiveness |
| Bench Testing | Completed and supports safety and effectiveness |
| Materials | Similar to predicate device (K111462) |
| Design | Similar to predicate device (K111462) |
| Performance Characteristics | Similar to predicate device (K111462) |
| Intended Use | Same as predicate device (K111462) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device submission, not a diagnostic algorithm. Performance was evaluated through biocompatibility and bench testing, not through a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. Safety and effectiveness are evaluated through engineering and biological testing.
4. Adjudication Method for the Test Set
Not applicable. See above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This device is not an AI/ML diagnostic tool, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. Evaluation relies on established engineering and biocompatibility standards, not diagnostic ground truth.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See above.
Study Proving the Device Meets Acceptance Criteria:
The submission states: "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." It further concludes: "The fiXate Tissue Band is similar in materials, design, and performance characteristics and has the same intended use as the original fiXate Tissue Band (K111462). Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance with voluntary performance standards."
The study that proves the device meets the (implied) acceptance criteria is the biocompatibility and bench testing. The details of these tests (e.g., specific protocols, results, number of samples tested for each bench test) are not provided in this 510(k) summary but would have been submitted to the FDA as part of the full application. The key outcome presented is that these tests confirmed the device is safe and effective and that it is substantially equivalent to its predicate device (K111462).
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).