(62 days)
The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump 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 (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). 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 a breakdown of the acceptance criteria and study information for the fiXate Tissue Band, based on the provided K113805 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K113805) describes functional and safety testing as part of the submission to demonstrate substantial equivalence, rather than setting specific numerical acceptance criteria for a direct comparison table. Instead, it relies on conformance to established standards and comparison to a predicate device.
| Acceptance Criteria Category | Description of Performance/Testing Conducted |
|---|---|
| Biocompatibility | Completed in accordance with ISO 10993-1 standards. |
| Tensile Strength | Performed to verify compliance with USP suture requirements. |
| Fixation Strength | Comparison completed to support the safety and effectiveness of the fiXate Tissue Band against the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a specific sample size for the "test set." It mentions "tensile testing" and "comparison of fixation strength," which implies testing on a certain number of devices or components. However, the exact number is not provided.
- Data Provenance: The nature of the tests (biocompatibility, tensile, and fixation strength) suggests these were prospective bench tests performed in a laboratory setting. There is no indication of country of origin for test data, but given the US submission, it's reasonable to assume the testing was conducted per US regulatory guidance or by labs compliant with such. There is no mention of patient data (retrospective or prospective) for this specific submission as it appears to be focused on physical and material properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This type of information is generally not applicable to the non-clinical, bench testing described in this 510(k). The "ground truth" for biocompatibility is conformance to ISO standards, for tensile strength it's USP suture requirements, and for fixation strength, it's a comparative assessment against a predicate device's established performance. These are objective measures rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective physical and chemical evaluations, not subjective clinical assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The fiXate Tissue Band is a surgical accessory, and its evaluation relies on bench testing and comparison of its physical properties to predicate devices.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant/accessory, not a software algorithm or AI-driven system.
7. Type of Ground Truth Used:
- Biocompatibility: Conformance to ISO 10993-1 standards.
- Tensile Strength: Compliance with USP (United States Pharmacopeia) suture requirements.
- Fixation Strength: Comparative data against the previously cleared fiXate Tissue Band (predicate devices) to demonstrate comparable safety and effectiveness.
Essentially, the "ground truth" for these tests are established engineering and material science standards, and the performance characteristics of an already cleared, substantially equivalent device.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).