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510(k) Data Aggregation
(352 days)
SBS
Lightin is a needle for injection laryngoplasty with an optical fiber. Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin. Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.
Lightin System consists of Lightin and Lightin Generator. Lightin is a light-guided needle used injection laryngoplasty and Light generator delivers the light energy to Lightin by generating LED light from an AC-powered light source. Lighin consists of injection needle, Y-connector and SMA connector/cable. The light transmitted from the Lightin Generator is emitted from the tip of fiber optics embedded within Lightin. Lightin system used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.
The provided document is a 510(k) summary for the Solmedix Lightin System, which is a medical device for injection laryngoplasty. This summary primarily focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in a format typical for an AI/ML device.
Here's an analysis based on the information provided, specifically addressing the points requested, while noting that many are not applicable or not explicitly detailed for this type of device submission:
1. Table of acceptance criteria and the reported device performance
For a Class I device seeking 510(k) clearance, the "acceptance criteria" are generally compliance with recognized standards and demonstration that the device performs as intended and is as safe and effective as a predicate device. This document lists the standards the device conforms to and describes various tests performed. It does not provide specific quantitative performance metrics with associated acceptance thresholds in the way an AI/ML device submission often would.
However, based on the non-clinical performance testing sections, we can infer some criteria and reported performance:
| Criterion Type | Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Lightin (Needle) | ||
| Biocompatibility | Conformity to ISO 10993 series for cytotoxicity, skin sensitization, irritation, systemic toxicity, and pyrogenicity. | Lightin was "accessed for conformity" and presumably passed all listed ISO 10993 tests (ISO 10993-5, -10, -23, -11) and USP Pyrogen Test. |
| Small-bore Connectors | Conformity to ISO 80369-7 and ISO 80369-20 for intravascular/hypodermic connectors and common test methods. | Lightin was "accessed for conformity" and presumably passed ISO 80369-7 and ISO 80369-20. |
| Hypodermic Needles | Conformity to ISO 7864 for sterile hypodermic needles. | Lightin was "accessed for conformity" and presumably passed ISO 7864. |
| Stainless Steel Needle Tubing | Conformity to ISO 9626 for stainless steel needle tubing. | Lightin was "accessed for conformity" and presumably passed ISO 9626. |
| Sterilization (Ethylene Oxide) | Conformity to ISO 11135 for EO sterilization development, validation, and routine control. | Lightin was "accessed for conformity" and presumably passed ISO 11135. |
| Packaging Integrity | Conformity to ASTM F1980 (Accelerated Aging), ASTM F1929 (Dye Penetration), and ASTM F88/F88M (Seal Strength). | Lightin was "accessed for conformity" and presumably passed ASTM F1980, ASTM F1929, and ASTM F88/F88M. |
| Sterility | Conformity to USP Sterility Test. | Lightin was "accessed for conformity" and presumably passed USP . |
| Light Output | Internal test standard for light output. | Lightin was "accessed for conformity" and presumably passed the internal light output test. (No specific quantitative value provided). |
| Thermal Measurement | Internal test standard for thermal measurement. | Lightin was "accessed for conformity" and presumably passed the internal thermal measurement test. (No specific quantitative value provided). |
| Performance (Laryngoplasty) | Successfully directs injection material to target area within the vocal fold. | The Lightin System "successfully directs the laryngoplastic injection material to the target area within the vocal fold." (Qualitative statement). |
| Tissue Heating Concerns | Addresses tissue heating concerns by tip illumination. | Tissue heating concerns by tip illumination were addressed. (Qualitative statement, likely related to the "Thermal measurement test"). |
| Lightin Generator | ||
| Electrical Safety & EMC | Conformity to IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC). | Lightin Generator was "accessed for conformity" and presumably passed IEC 60601-1 and IEC 60601-1-2 (including IEC TR 60601-4-2 guidance). |
| Photobiological Safety | Conformity to IEC 62471 for photobiological safety of lamps and lamp systems. | Lightin Generator was "accessed for conformity" and presumably passed IEC 62471. |
| Light Output | Internal test standard for light output. | Lightin Generator was "accessed for conformity" and presumably passed the internal light output test. (No specific quantitative value provided beyond the max output ≤ 8mW in the comparison table). |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the tests conducted or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or provided in a 510(k) summary for a Class I manual surgical instrument unless specific performance claims necessitate it. The tests listed are primarily engineering, electrical, and biocompatibility tests on device components or finished products, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is a surgical instrument, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation of data to establish ground truth for training or testing. The "ground truth" for this device relates to its physical performance, safety, and functionality (e.g., biocompatibility, sterility, light output), which are assessed through standardized laboratory and technical tests.
4. Adjudication method for the test set
This is not applicable for the reasons stated in point 3.
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
This is not applicable, as the device is not an AI/ML product designed to assist human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an AI/ML algorithm. It is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through adherence to recognized international and national standards (e.g., ISO, IEC, ASTM, USP) for materials, electrical safety, biocompatibility, sterilization, and basic functionality. For instance, successfully passing a cytotoxicity test per ISO 10993-5 serves as the "ground truth" for non-cytotoxicity. The statement that the system "successfully directs the laryngoplastic injection material to the target area" is a functional performance claim, likely verified through internal testing or benchtop models.
8. The sample size for the training set
This is not applicable, as there is no mention of a training set for an AI/ML model for this device.
9. How the ground truth for the training set was established
This is not applicable.
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