The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

Device Description

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting.

The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.

AI/ML Overview

The provided document describes the Ostom-i™ Alert, an accessory for ostomy bags. The device monitors the filling of the bag and sends an alert via Bluetooth to a tablet computer when the bag is close to being full. The document focuses on demonstrating the device's substantial equivalence to a predicate device (Hollister, Inc.'s Two Piece Ostomy System, K813269) rather than presenting a traditional clinical study with acceptance criteria and statistical performance metrics for diagnostic accuracy.

Here's an attempt to extract and synthesize the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific diagnostic accuracy metrics (like sensitivity, specificity, accuracy) for the Ostom-i™ Alert. Instead, it focuses on qualitative performance and safety aspects as part of demonstrating substantial equivalence. The "performance" reported is primarily about its function and usability, not diagnostic accuracy against a ground truth.

Acceptance Criteria Category	Specific Criteria (Implicitly from testing)	Reported Device Performance (Summary from study)
Usability (Healthcare Professional)	Ability to read and understand Instructions for Use.	Demonstrated for "11 Health Ostom-i™ Hospital App with the Ostom-i™ Alert Sensor" by nurses.
	Ability to interface with Tablet (input patient info).	Demonstrated.
	Ability to attach sensor to ostomy bag.	Demonstrated.
	Ability to pair sensor to Tablet.	Demonstrated.
	Ability to trigger alert condition.	Successfully simulated by curving the bag.
Patient Usability (Physical Activities)	Maintain functionality during various patient activities.	Successfully tested during: standing, lying down, sitting down with bag folded, climbing stairs, rolling over 360 degrees, bending over, driving.
Environmental Robustness	Maintain functionality when exposed to water.	Successfully maintained functionality when "device dropped in water" and "water splashed on device."
Biocompatibility	Meet ISO 10993 standards.	Complied with (testing conducted).
Electromagnetic Compatibility (EMC)	Meet relevant EMC standards.	Complied with (testing conducted).
Wireless Coexistence	Operate without interference and interfere with other devices.	Complied with (testing conducted).
Label Comprehension	Labels are understandable by intended users.	Study conducted.
Functional Equivalence	Provide fill status and alert similar to visual inspection.	"Technological improvement over intermittent visualization" and "technological advance of simple visualization of ostomy fill."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the "test set" in the traditional sense of a diagnostic performance study.

For the "Usability and Label Comprehension Study by Intended User," it mentions "nurses who would use this in a hospital setting" but does not give a number of participants.
For "Patient Usability Testing," it refers to "Patients" but does not specify how many patients or simulations were involved.

The data provenance is not explicitly stated in terms of country of origin, nor is it clearly categorized as retrospective or prospective for a clinical study. The usability and performance testing described appear to be prospective tests conducted as part of the device development and submission process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Since the device's function is to alert based on physical fill rather than interpret complex imagery or physiological signals, the "ground truth" for the fill level would likely be objective (e.g., measured volume, physical observation of a full bag). The "experts" involved were primarily "nurses" for the usability study, but their role was to evaluate usability, not to establish ground truth for a diagnostic task.

4. Adjudication Method

No adjudication method is mentioned for establishing ground truth, as the studies described are not focused on diagnostic accuracy requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The document does not describe a study comparing human readers (with vs. without AI assistance) or quantifying an effect size of improvement. The device acts as a direct monitor and alert system, not an AI to assist human interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted, though it's not a "standalone algorithm performance" in the typical sense of a diagnostic AI. The "Performance Testing" section describes various tests (patient usability, environmental robustness, biocompatibility, EMC, wireless coexistence) that evaluate the device's function and safety independently. The device's core function is to detect and report bag fullness, which was tested by simulating an alert condition.

7. Type of Ground Truth Used

The ground truth implicitly used for the device's primary function (alerting when the bag is full) is physical observation/simulation of a full bag. This is supported by:

"An alert was simulated by curving the bag to the filling of the bag thereby creating the alarm condition."
The "flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag."

For usability studies, the ground truth is subjective user feedback and observation of task completion.

8. Sample Size for the Training Set

This information is not applicable or provided. The Ostom-i™ Alert appears to be a sensor-based device that directly measures and converts physical changes (flex/curvature) to volume, rather than an "algorithm" in the machine learning sense that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable or provided, as there is no mention of a training set for a machine learning algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads or faces.

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

October 10, 2014

11 Health and Technologies LLC % EJ Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K140938

Trade/Device Name: Ostom-i™ Alert Regulation Number: 21 CFR§ 876.5900 Regulation Name: Ostomy Bag Accessory Regulatory Class: I Product Code: EXB, EZO, EZS Dated: September 2, 2014 Received: September 2, 2014

Dear EJ Smith,

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.

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

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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" (21 CFR 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,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140938

Device Name OSTOM-iTM Alert

Indications for Use (Describe)

The OSTOM-1™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare persomel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140938

Device Name OSTOM-iTM Alert

Indications for Use (Describe)

The OSTOM-i™ Alert is indicated for all patient populations.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary 807.92(c)

SPONSOR		807.92(a)(1)
Company Name:	11 Health Technologies
Company Address	Kinetic Business CentreTheobald StreetBorehamwood WD6 4PJUnited Kingdom
Telephone:	+44 (0) 20 8387 4000
Contact Person:	Michael Seres

Summary Preparation Date: October 9, 2014

DEVICE NAME

807.92(a)(2)

Trade Name:	Ostom-i
Common/Usual Name:	Ostomy Bag/Pouch
Classification Name:	Collector, Ostomy
Regulation Number:	21 CFR 876.5900
Regulation Name:	Ostomy Pouch and Accessories
Product Code:	EXB, EZQ, EZS
Device Class:	Class I

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device

K Number	Product Name	Manufacturer
K813269	Two Piece Ostomy System	Hollister, Inc

DEVICE DESCRIPTION

807.92(a)(4)

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DEVICE INDICATIONS FOR USE

807.92(a)(5)

Prescription Use Only

The OSTOM-i™ Alert is indicated for all patient populations.

ОТС

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensorbased OSTOM-i™ Alert is intended to be used by the patient outside of the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

Parameters	11 Health and Technologies, LLC	Hollister, Inc.
K number		K813269
RegulatoryClassification	Class I Exempt21 CFR 876.5900	Class I Exempt21 CFR 876.5900
Product Code	EXB	EXB
Indications forUse	The OSTOM-i™ Alert is intended tobe used as an accessory to anyostomy bag by monitoring the fillingof the bag which information is sentvia Bluetooth to a tablet computerto warn healthcare personnel whena patient's bag is close to being full.The Tablet computer automaticallycaptures the data as to the volumeand timing of output for eachpatient.The sensor-based OSTOM-i™ Alertattaches to any ostomy bag and isable to send messages via Bluetoothto a mobile app to warn patientwhen ostomy bag is close to being	An ostomy pouch and accessories is adevice that consists of a bag that isattached to the patient's skin by anadhesive material and that is intendedfor use as a receptacle for collection offecal material or urine following anileostomy, colostomy, orureterostomy (a surgically createdopening of the small intestine, largeintestine, or the ureter on the surfaceof the body).

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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	full. The sensor-based OSTOM-i™™Alert is intended to be used by thepatient outside of the hospitalenvironment.
	The OSTOM-i™ Alert is indicated forall patient populations.
Use environment	Hospital and home use	Hospital and home use
PatientPopulation	Patients using Ostomy Bags	Patients using Ostomy Bags
Disposable	Single patient use	Single patient use
Device Design:Collection	Ostomy bag with portable levelsensor attached	Ostomy bag
Device Design:Fill Status	Visual and alert via sensor detectionwhich sends fill alert via Bluetoothto a dedicated device, a tabletcomputer	visual

NON-CLINICAL PERFORMANCE DATA

807.92(b)(1)

Performance Testing-Usability and Label Comprehension Study by Intended User

The testing for ease of use and label comprehension of the 11 Health Ostom-i™ Hospital App with the Ostom-i™ Alert Sensor by nurses who would use this in a hospital setting was the object of this usability study. Nurses are the primary caregivers in the maintenance of ostomy bags in the hospital setting.

The usability factors included the ability of the healthcare professional to read and understand the Hospital App Instructions for Use, interface with Tablet by inputting patient information, attach the sensor to the ostomy bag and after enabling the battery, pair the sensor to the Tablet. An alert was simulated by curving the bag to the filling of the bag thereby creating the alarm condition.

PERFORMANCE TESTING

The following performance tests were conducted:

. Patient Usability Testing:
- o Patients standing
- o Patients lying down

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Patients sitting down with ostomy bag folded in half o
Device dropped in water o
o Water splashed on device
Patient climbing stairs o
o Patient rolling over 360 degrees
o Patient bending over
o Patient driving
Label comprehension study
Usability study by ICU registered nurses
Biocompatibility testing in accordance with ISO 10993
Electromagnetic compatibility
Wireless coexistence

CONCLUSION

807.92(b)(3)

The primary intended use of an ostomy bag is a collection device. The OSTOM-i™ Alert is an accessory to the ostomy bag which does not alter an ostomy bag's function as a collection device but rather adds a graphic fill status and alert of critical fill level to the healthcare provider via BlueTooth to a tablet computer, which is a technological improvement over intermittent visualization. In addition, information concerning amount of out- put and time of output is available for clinical purposes, if clinically indicated. The OSTOM-i™ Alert raises no new issues of safety and effectiveness for its intended use, but is a technological advance of simple visualization of ostomy fill and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.5900 Ostomy pouch and accessories.

(a)
Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.