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510(k) Data Aggregation
(300 days)
LJT SURGICAL LTD
The StopLoss Jones tube system is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.
The StopLoss Jones Tube assembly consists of a flanged glass tube and silicone washer. The glass tube is Pyrex borosilicate glass and the silicone is NuSil. It is offered in a range of sizes as follows: ID 1.15 -1.25mm OD 1.90 - 2.10mm Lengths 9-22mm +/-0.5mm in 1mm increments The device is provided sterile for single use only.
The provided text describes a 510(k) premarket notification for the "StopLoss Jones Tube System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical or AI-centric study.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and how it was established for training and test sets, training set sample size) are not applicable to this type of submission.
Here's the information that can be extracted from the provided text, formatted to address your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the way one might for a software algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" can be inferred as the successful completion of various non-clinical tests demonstrating the device's functional integrity, biocompatibility, and sterility, in comparison to predicate devices. The "reported device performance" refers to the successful outcomes of these tests.
| Test Performed (Inferred Acceptance Criterion) | Reported Device Performance |
|---|---|
| Bond strength between glass tube and silicone washer maintained after stability testing | Evaluated successfully using calibrated Instrom equipment during stability testing. (Specific numerical metric not given, but "evaluated" implies satisfactory performance). |
| Internal low profile for intubation of lacrimal anatomy | Established using a pig nose model. (Implies successful demonstration of fit/design for intended anatomical use). |
| Sterilization validation (SAL of 10^-6) | Performed to assure the SAL of 10^-6. (Implies successful validation). |
| Packaging and shelf life (5-year shelf life) | Testing allows for labeling the device with a 5-year shelf life. (Implies successful validation for 5 years). |
| Maintenance of integrity after shipping | A transportation validation study confirmed maintenance of integrity. (Implies successful validation). |
| Non-pyrogenicity | The device was tested to assure it is non-pyrogenic. (Implies successful demonstration). |
| Biocompatibility | Biocompatibility of the materials and the final device have been presented in the 510(k). (Implies successful demonstration/assessment). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for non-clinical bench tests. For example, "a pig nose model" was used, but the number of models or tests conducted is not quantified.
- Data Provenance: The tests described are non-clinical bench tests and likely laboratory-based. The location or specific origin of the pig nose model (e.g., country) is not disclosed.
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 medical device for surgical intubation, not an AI diagnostic/prognostic device requiring expert-labeled ground truth for a test set. The validation relies on engineering and biological testing.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus) are relevant for subjective interpretations of data, often in clinical trials or AI performance evaluations, which is not the nature of this 510(k) submission.
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 not an AI-assisted diagnostic device. No human reader performance studies of this nature were conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in AI or diagnostic studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance is established by meeting predefined engineering specifications, material safety standards, and functional requirements through objective bench testing and validation studies (e.g., bond strength measurement, sterility testing, biocompatibility assessment).
8. The sample size for the training set
Not applicable. There is no machine learning "training set" for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no machine learning "training set" for this physical device.
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