STOPLOSS JONES TUBE by LJT SURGICAL LTD

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2014

LJT Surgical Ltd. c/o Patsy J. Trisler, JD, RAC Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815

Re: K140290

Trade/Device Name: StopLoss Jones Tube Regulation Number: Preamendment Regulation Name: Preamendment Regulatory Class: Unclassified Product Code: OKS Dated: October 21, 2014 Received: October 24, 2014

Dear Ms. Trisler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K140290

StopLoss Jones Tube System Device Name:

Indications for Use:

The StopLoss Jones tube system is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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510(k) SUMMARY

Submitter Name:	LJT Surgical, Ltd.
Submitter Address:	3-15 Wallace WayHitchin, HertfordshireSG4 OSE England
Contact Person:	Andrew PearsonManaging Director
Phone Number:	44 1628 782537
Date Prepared:	January 30, 2014; Revised October 6 2014
Device Trade Name:	StopLoss Jones Tube System
Device Classification:	Unclassified
Regulatory Name:	Lacrimal Stent and Intubation Set
Classification Number:	n/a
Product Code:	OKS
Predicate Device(s):	Gunther Weiss Scientific Glassblowing Co., Inc.: Jones Tube(Pre-Amendment device)DCS Surgical, Inc., DCS Lacrimal Stent (K113316)
Indications for UseStatement:	The StopLoss Jones tube system is intended for use duringrepair of the lacrimal system for intubation and bypass tocanalicular pathologies.
Device Description:	The StopLoss Jones Tube assembly consists of a flanged glasstube and silicone washer. The glass tube is Pyrex borosilicateglass and the silicone is NuSil. It is offered in a range of sizes asfollows:ID 1.15 -1.25mmOD 1.90 - 2.10mmLengths 9-22mm +/-0.5mm in 1mm incrementsThe device is provided sterile for single use only.
Summary of Testing:	The following non-clinical bench tests were performed:The strength of the bond between the glass tube and the siliconewasher using calibrated Instrom equipment was evaluated duringstability testing.A pig nose model was used to establish the internal low profilefor intubation of the lacrimal anatomy.Sterilization validation has been performed to assure the SAL of10-6, and packaging and shelf life testing allows for labeling thedevice with a 5-year shelf life.

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The device was tested to assure maintenance of integrity after shipping (a transportation validation study).

The device was also tested to assure it is non-pyrogenic.

Biocompatibility of the materials and the final device have been presented in the 510(k).

Comparison to the The StopLoss Jones Tube has the same intended use and the Predicate Devices: same principles of operation as both predicates. The materials used are the same as the borosilicate glass and silicone used to make the predicate devices.
The primary technological differences are that the StopLoss tube was designed with a silicone safety washer/flange which is not present on either predicate.

This difference does not introduce new types of questions of safety and effectiveness. The testing performed on the integrity of the flange and bond strength sufficiently addresses this difference.

Substantjal The comparisons and study data presented in the 510(k) lead to Equivalence the conclusion that StopLoss Jones Tube is substantially Conclusion: equivalent to the predicate devices.

Regulation Number and Section

N/A