(184 days)
The Medtronic Twist Lock Anchor, Part Number 103953 or Model 3550TLA, is indicated as an alternate anchor accessory for use with Spinal Cord Stimulation (SCS) Systems for the treatment of chronic intractable pain of the trunk or limbs. The Twist Lock Anchor is only for use with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads with an outside diameter of 1.27 mm. All other uses are contraindicated.
The Medtronic Twist Lock Anchor is an implantable device. It is used with Spinal Cord Stimulation (SCS) systems for the treatment of chronic intractable pain of the trunk or limbs. The anchor is assembled from three parts: the driver and the shell which are made of polysulfone, and a stainless steel pin which is press fitted into the shell. The compression created by the fit of the driver within the shell grips the lead body outer jacket. The Medtronic Twist Lock Anchor can be used only with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads that require anchor sleeve and that have an outside diameter of 1.27 mm.
The provided document describes the Medtronic Twist Lock Anchor, an implantable device used with Spinal Cord Stimulation (SCS) systems. The study presented is for the purpose of demonstrating substantial equivalence to a predicate device, as required for a 510(k) Pre-market Notification, rather than proving a novel device meets specific performance acceptance criteria from a clinical trial. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study details, training set size) is not applicable or not provided in this specific type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the "Twist Lock Anchor" in the format of a table as it's a submission for substantial equivalence to a predicate device, not a de novo device requiring new performance benchmarks. Instead, it aims to show equivalence in key performance aspects to an existing device. The performance is described qualitatively as "equivalent" or "substantially equivalent" to the predicate.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Function | Equivalent to the current silicone rubber anchor | Same function as the current silicone rubber anchor |
| Intended Use | Equivalent to the current silicone rubber anchor | Same intended use as the current silicone rubber anchor |
| Gripping Method | Equivalent to the current silicone rubber anchor (compression based) | Grips using compression, equivalent to silicone rubber anchor |
| Gripping Strength | Substantially equivalent to the current silicone rubber anchor | Breakaway load equivalent to the current silicone rubber anchor |
| Flex Characteristics | Equivalent to the lead body gripped by the current silicone anchor | Lead body while gripped has equivalent flex characteristics |
| Tissue Securement | Equivalent to the current silicone rubber anchor (sutures) | Secured by sutures, same as current silicone rubber anchor |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Flex testing" and "Pull testing" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated but would typically be generated in-house by Medtronic as part of their device development and testing. It represents retrospective engineering test data, not prospective clinical data from specific countries.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the "test set" here refers to engineering performance tests (flex and pull testing) on the device itself, not a diagnostic or clinical test where expert ground truth would be established from patient data.
4. Adjudication Method for the Test Set
This is not applicable for engineering performance tests. Adjudication methods (like 2+1) are typically used for clinical endpoints or diagnostic interpretations involving human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in this document. This submission focuses on demonstrating substantial equivalence of a physical medical device (an anchor) rather than evaluating the diagnostic or interpretive accuracy of an AI algorithm in a clinical setting with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is an implantable mechanical anchor, not an algorithm. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
The "ground truth" for the performance tests (flex and pull) would be the measured physical properties and mechanical performance of the device under test conditions, directly compared to the measured performance of the predicate device. It's based on engineering specifications and test protocols, not expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
This is not applicable. The device is a mechanical anchor, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a mechanical 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).