Search Results
Found 1 results
510(k) Data Aggregation
(274 days)
The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery.
The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.
target nerves and to locally stimulate them in order to provide a measurable response. The stimulus will have a very small current spread to reduce the innervation of the surrounding nerves.
The concentric design has two main parts, an inner stainless steel wire and an outer cannula also insulated from reading un-intended signals.
The Inner wire is isolated from the outer stainless steel cannula using a biocompatible heat shrink tubing. This Inner Wire acts as the stimulator and is surrounded by the outer cannula. The Outer Cannula is isolated with a biocompatible heat shrink which isolates the outer cannula allowing contact in a localized area of the intended nerves of interest.
The inner wire, the cathode, is stimulated using EMG/EP electroneurodiagnostic equipment cleared for the stimulation of nerve tissue and recording muscle activity during surgical procedures (not part of this 510(k) submission) The outer cannula acts as the anode or reference.
The Inner wire and outer cannula are isolated from each other using a dielectric heat shrink and are connected to a color coded pair of leadwires which are terminated by two DIN 42 802 touch proof connectors. The concentric stimulators are terminated on the distal end inside of a plastic handle and are independently connected to the leadwires.
This document describes a 510(k) submission for the Rhythmlink Disposable Concentric Stimulation Probe. It outlines the safety and effectiveness testing to demonstrate substantial equivalence to a predicate device, not the performance of an AI model. Therefore, many of the requested fields related to AI model acceptance criteria and study design are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional | Probe diameter and lengths within specified ranges (comparable to predicate) | Conducted (specific ranges not explicitly stated, but implied to be acceptable based on comparison to predicate in "Technological Characteristics" table) |
| Performance - Continuity | 0.5 Ohms | Achieved 0.5 Ohms |
| Performance - Hi Pot | No insulator breakdown | Passed (testing of insulator breakdown conducted and analyzed) |
| Performance - Stimulation Delivery | Effective stimulation delivery (comparable to predicate) | Conducted and analyzed (implied to be effective for intended use) |
| Performance - Pull-off Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Performance - Leadwire Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Sterilization | Current, validated EO Sterilization Cycle 93007 met; acceptable residual EtO and ECH levels | Sterilized under Cycle 93007; residuals at "lowest possible limits" |
| Biocompatibility - ISO BET Get Clot Testing | No interference with lysate reaction; no inhibition or enhancement; no clotting at neat concentration; geometric mean endpoint concentration < 0.06 EU/mL and < 0.9 EU/Device of bacterial endotoxin. | The system did not interfere with the lysate reaction, and no inhibition or enhancement was present. The test articles did not clot at the neat concentration. The geometric mean endpoint concentration of each test article was <0.06 EU/mL and each contained <0.9 EU/Device of bacterial endotoxin. Results acceptable. |
| Biocompatibility - USP Inhibition and Enhancement Testing, Gel Clot Method | No inhibition or enhancement of Bacterial Endotoxin Test according to USP guidelines. | The test Concentric Stimulation Probe does not inhibit or enhance the Bacterial Endotoxin Test according to the USP guidelines. |
| Biocompatibility - ISO MEM Elution Test | No biological reactivity (Grade 0) of cells exposed to test article extract. Positive and negative controls confirm suitability. | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. The response obtained from the positive and negative control article extracts confirmed the suitability of the test system. |
| Biocompatibility - ISO Intracutaneous Reactivity Test | Test article sites do not show significantly greater biological reaction than control article sites. | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test conducted. It states "Non-clinical bench testing was comprised of dimensional measurements and performance tests." and "biocompatibility tests on the device". The data provenance is internal to the manufacturer (Rhythmlink International, LLC) and likely collected in a laboratory setting as part of product development and regulatory submission. This is not patient data; it's device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm. Ground truth, in the context of an AI model, refers to the verified correct output for a given input. For this device, "ground truth" is established through engineering specifications, validated test methods, and compliance with industry standards (e.g., ISO, USP). There are no "experts" establishing ground truth in the sense of clinical annotations for AI.
4. Adjudication method for the test set
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm. Adjudication methods are relevant for resolving discrepancies in expert opinions used to create labels for AI training/test sets.
5. 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 a submission for a medical device (stimulating probe), not an AI algorithm. An MRMC study pertains to the evaluation of diagnostic performance involving multiple human readers and an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm.
7. The type of ground truth used
For the non-clinical tests:
- Dimensional: Engineering specifications and comparisons to the predicate device.
- Performance Tests (Continuity, Hi Pot, Stimulation Delivery, Pull-off, Leadwire Strength): Engineering specifications and functional requirements based on the intended use and predicate device's performance.
- Sterilization: Regulatory standards for ethylene oxide sterilization and validated processes.
- Biocompatibility: Established international (ISO) and national (USP) standards for biological evaluation of medical devices, with pass/fail criteria defined by these standards.
8. The sample size for the training set
Not applicable. This is a submission for a medical device (stimulating probe). There is no "training set" in the context of artificial intelligence. The device design and manufacturing processes are validated through engineering and biocompatibility tests.
9. How the ground truth for the training set was established
Not applicable. As there is no AI training set, this question is not relevant.
Ask a specific question about this device
Page 1 of 1