(29 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.
The provided text is a 510(k) summary for the fiXate Tissue Band and does not contain detailed information about specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy. The summary focuses on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or detailed performance metrics are reported in this document. The document states "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This indicates that some form of testing was done to ensure safety and effectiveness, but the specific criteria and results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a clinical study or a test set involving patient data where such information would typically be relevant. The testing mentioned appears to be bench testing and biocompatibility testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No expert review or ground truth establishment relevant to an AI/diagnostic device performance study is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not describe an MRMC study or any study where human readers' performance with and without AI assistance was evaluated.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. The fiXate Tissue Band is a physical medical device (an accessory to Spinal Cord Stimulator systems), not an algorithm or AI device. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used:
Not applicable. As this is not an AI/diagnostic device, the concept of "ground truth" in that context does not apply. The "ground truth" for a physical device like this would be its physical properties, biocompatibility, and mechanical performance, established through bench testing and material analyses.
8. The Sample Size for the Training Set:
Not applicable. As this is a physical medical device, not an algorithm or AI device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set is involved.
Summary of what is available from the document regarding "acceptance criteria" and "study":
- Acceptance Criteria (Implied): The implied acceptance criteria for the fiXate Tissue Band are related to its safety and effectiveness, as demonstrated through biocompatibility and bench testing. The key "acceptance" was the FDA's determination of substantial equivalence to existing predicate devices (K111462 and K112849). This means the device was found to be as safe and effective as the previously cleared devices.
- Study: The document mentions that "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This refers to non-clinical studies evaluating the material properties and mechanical performance of the physical device. Specific details about these tests, their protocols, or results are not included in this summary.
In essence, this 510(k) summary focuses on demonstrating that the fiXate Tissue Band is a modified version of an already cleared device and meets the necessary non-clinical standards for safety and performance, rather than presenting a clinical study with detailed performance metrics.
§ 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).