(105 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.
Here's an analysis of the provided information regarding the fiXate Tissue Band (K111462) from the perspective of acceptance criteria and supporting studies:
Based on the provided K111462 summary, there is no specific performance study involving a test set, ground truth established by experts, or AI performance reported. This device clearance is based on substantial equivalence to predicate devices, supported by functional and safety (benchtop) testing and biocompatibility assessments.
Therefore, I cannot populate most of the requested fields as they pertain to clinical or algorithm performance studies that were not conducted or reported in this 510(k) summary.
However, I can extract information relevant to the device's functional and safety testing, which implicitly serves as the "study that proves the device meets acceptance criteria" within the context of a 510(k) based on substantial equivalence.
Acceptance Criteria and Device Performance (Based on Provided Information)
| Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Biocompatibility: Device materials must be biocompatible and safe for implantation. | Biocompatibility testing was completed and supports the safety of the fiXate Tissue Band. (Specific results or standards not detailed in summary). |
| Functional Performance (Bench Testing): Device must perform as intended (e.g., secure lead, maintain integrity). | Bench testing was completed and supports the safety and effectiveness of the fiXate Tissue Band. (Specific tests, acceptance criteria, or quantitative results not detailed in summary). |
| Similar Intended Use: Must have the same intended use as predicate devices. | The fiXate Tissue Band has the same intended use as the predicate Advanced Neuromodulation Systems Swift-Lock Anchor (K092371). |
| Similar Materials: Must use similar materials to predicate devices. | The fiXate Tissue Band is similar in materials to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
| Similar Design: Must have a similar design to predicate devices. | The fiXate Tissue Band is similar in design to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
| Similar Performance Characteristics: Must exhibit similar performance to predicate devices. | The fiXate Tissue Band is similar in performance characteristics to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
Explanation of "Acceptance Criteria" in this Context: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are generally met when the new device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is primarily achieved through showing similarity in intended use, technology, design, materials, and performance characteristics, often supported by bench testing and biocompatibility studies rather than complex clinical efficacy trials. The "reported device performance" is essentially the conclusion that these similarities have been demonstrated.
Additional Study Information (Based on Provided Document)
- Sample size used for the test set and the data provenance: Not applicable. The summary mentions "bench testing" but does not provide details on sample sizes or data provenance. This is typical for bench-top mechanical/functional tests, which are not usually reported with "test sets" in the clinical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert-established ground truth was reported.
- Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication was reported.
- 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. This is not an AI device, and no MRMC study was reported.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device, and no algorithm-only performance study was reported.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was used or reported. The "ground truth" for this device's clearance is its demonstrated equivalence to known safe and effective predicate devices, supported by engineering tests.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
Summary of Device Evaluation for K111462:
The fiXate Tissue Band received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Anulex Technologies Versaclose, Anulex Technologies Xclose™ Tissue Repair System, and Advanced Neuromodulation Systems Swift-Lock Anchor). The "study" proving it meets acceptance criteria consists of:
- Bench Testing: To assess functional performance, safety, and mechanical properties.
- Biocompatibility Testing: To ensure the materials are safe for implantation.
- Comparative Analysis: A detailed comparison of the new device's intended use, materials, design, and performance characteristics with those of the predicate devices.
The conclusion drawn by the FDA is that these tests and comparisons demonstrate the new device is as safe and effective as the predicates, thereby meeting the requirements for 510(k) clearance. Clinical studies involving human subjects with defined test sets, expert ground truth, or AI performance metrics were not part of this submission's basis for clearance.
§ 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).