The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.

Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia

Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.

The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.

Not for use in pediatric patients.

Device Description

The SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to aid in the evaluation of gastrointestinal motility diseases and conditions. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times: GET - Gastric emptying (transit) time SBTT - Small bowel transit time SLBTT - Combined small and large bowel transit time CTT - Colonic transit time WGTT - whole gut transit time

AI/ML Overview

The provided text describes the SmartPill GI Monitoring System, Version 2.0, and its performance evaluation. However, it does not explicitly detail acceptance criteria in a quantitative table format or a study specifically designed to prove all acceptance criteria. Instead, it discusses clinical testing that "validated the device's indications for use" and "support the product's intended use, indications for use, performance and clinical claims."

Here's an attempt to extract and synthesize the information based on your request, with significant limitations due to the lack of explicit detail in the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document does not present a formal table of acceptance criteria with corresponding performance metrics from a single, comprehensive study. Instead, it broadly states that "clinical testing was conducted to validate the device's indications for use." The performance summary refers to "multiple bench tests to verify the accuracy and precision of the device" and "clinical testing" that "support the product's intended use, indications for use, performance and clinical claims."

Inference: The "acceptance criteria" appear to be broadly defined by the "Indications for Use" and the ability of the device to measure specific GI transit times (Gastric Emptying Time, Small Bowel Transit Time, Combined Small and Large Bowel Transit Time, Colonic Transit Time, Whole Gut Transit Time) accurately enough to aid in evaluating motility disorders. The clinical studies likely aimed to establish and validate normal and abnormal ranges for these transit times, thereby demonstrating the device's utility in clinical decision-making.

Given the lack of specific quantitative acceptance criteria in the document, a hypothetical table based on the implied performance goals of the device would look like this:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion (Inferred from Indications for Use)	Reported Device Performance (General Statement from Document)
Gastric Emptying Time (GET)	Device accurately measures GET for evaluation of suspected gastroparesis.	Clinical testing validated indications for use.
Colonic Transit Time (CTT)	Device accurately measures CTT for evaluation of chronic constipation and differentiation of slow/normal transit.	Clinical testing validated indications for use and established cutoff values.
Combined Small and Large Bowel Transit Time (SLBTT)	Device accurately measures SLBTT as a surrogate for CTT when CTT cannot be determined.	Clinical testing validated indications for use and established cutoff values.
Whole Gut Transit Time (WGTT)	Device accurately measures WGTT.	Clinical testing validated indications for use.
pH Measurement	Device accurately measures pH throughout the GI tract.	"Senses and records pH... from the entire length of the gastrointestinal tract." Performance verified in multiple bench tests.
Pressure Measurement	Device accurately measures pressure contraction data from antrum and duodenum for motility indices.	"Senses and records... pressure measurements from the entire length of the GI tract." Performance verified in multiple bench tests.
Biocompatibility	Patient-contacting materials are non-sensitizing, non-toxic, non-irritating.	Passed ISO-10993 Part I and USP <661> tests.
Electrical Safety	Device meets electrical safety standards.	Met IEC 60601-1 requirements.
Electromagnetic Compatibility (EMC)	Device meets EMC standards.	Met IEC 60601-1-2 requirements.

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

The document mentions two prospective clinical studies:

Study 1: "established cutoff values for colonic and combined small large bowel transit time."
Study 2: "validated the cutoff values in symptomatic constipated patients."

Sample Size: The exact sample sizes for these clinical studies (test sets) are not provided in the excerpt.
Data Provenance: The studies were prospective clinical studies. The country of origin is not specified, but given the FDA submission, it's likely conducted in the US or under protocols recognized by the FDA.

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

This information is not provided in the document. The method for establishing ground truth for human interpretation of transit times or the involvement of experts in determining "cutoff values" is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable as the device is a diagnostic capsule system that measures physiological parameters. It is not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed (or at least not mentioned as such). The device provides automated data analysis ("MotiliGIT™ Software performs data analyses automatically").

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times." This implies a standalone algorithmic processing of the capsule's data to derive the transit times. The clinical studies would then assess the accuracy and clinical utility of these automatically derived transit times against clinical outcomes or other diagnostic standards. The "performance of the SmartPill GI Monitoring System" in bench tests and clinical trials implies an assessment of the device's (including its algorithms) ability to correctly measure and report the relevant physiological parameters.

7. The Type of Ground Truth Used

The document generally states that clinical testing validated "indications for use" and established "cutoff values." For a device measuring physiological transit times, the ground truth would likely involve:

Clinical Outcomes Data: For example, in patients with suspected gastroparesis or chronic constipation, the transit times measured by the SmartPill would be correlated with definitive clinical diagnoses, patient symptoms, or responses to treatment.
Comparison to Established Diagnostic Methods: Although not explicitly stated as "ground truth," the mention of "Konsyl Sitzmarks" as a predicate device for colonic transit time suggests that the SmartPill's CTT measurements might have been compared to this established method, which uses radiopaque markers to assess colonic transit.
Expert Consensus: Likely involved in establishing the "cutoff values" based on clinical expertise and observed patient populations.

8. The Sample Size for the Training Set

The document explicitly mentions "two prospective clinical studies" that involved establishing and validating cutoff values. It does not specify separate "training" and "test" sets in the context of machine learning model development or explicit algorithm training. However, the first study "established cutoff values" which could functionally serve as a "training" or "calibration" phase, and the second study "validated the cutoff values," acting as a "test" phase.

Sample Size: The exact sample sizes for these studies are not provided.

9. How the Ground Truth for the Training Set Was Established

As inferred above, if the "first study" that "established cutoff values" is considered the training phase:

The ground truth would likely have been established through clinical observation and correlation with patient diagnoses and symptoms in a population of subjects relevant to the device's indications (e.g., healthy individuals to define normal ranges, and patient populations with known gastroparesis or constipation to define abnormal ranges).
It's probable that medical experts (e.g., gastroenterologists) were involved in interpreting the results and setting these cutoff values based on clinical utility and statistical analysis of the study data. The document does not provide details on the specific methods used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a partial logo on the left and the word "DEPARTMENT" on the right. The logo includes the words "HUMAN SERVICES-USA" arranged in a circular fashion. Below the word "DEPARTMENT" is a horizontal line.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Kathleen H. Selover Director, Regulatory Affairs and Quality The SmartPill Corporation 847 Main Street Buffalo, New York 14203-1109

JAN 1 0 2017

Re: K092342

Trade/Device Name: SmartPill GI Monitoring System, Version 2.0 Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: NYV Dated: July 29, 2009 Received: August 4, 2009

Dear Ms. Selover:

This letter corrects our substantially equivalent letter of October 30, 2009.

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. Insting 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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

{1}------------------------------------------------

Page 2 - Ms. Kathleen H. Selover

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 Parts 801 and 809] ), 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/ReportalProblem/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,

Benjamin R. Fisher -S

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

Enclosure

{2}------------------------------------------------

SMARTPILL CORPORATION 510(K) SUBMISSION - SECTION 4 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0

SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number: not assigned

Device Name: SmartPill GI Monitoring System, version 2.0

Indications for Use:

The SmartPill GI Monitoring System measures whole gut and regional gut (stornach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.

Colonic transit time (CIT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.

The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.

Not for use in pediatric patients.

X Prescription Use

(Per 21CFR 801.109) Over-the-Counter Use _

Concurrence of CDRH, Office of Device Evaluation (ODE)

thom N. Vta

Division of Reproductive. Abdomi and Radiological Devi

Radiological Devices,
510(k) Number K092342

{3}------------------------------------------------

510(k) Submission, Section 5
Page 1 of 3
K092342

SMARTPILL CORPORATION 510(K) SUBMISSION - SECTION 5 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0

SECTION 5: 510(K) SUMMARY

Date of Summary:

OCT 9 2008

Manufacturer:	The SmartPill Corporation847 Main StreetBuffalo, NY 14203
Contact Information:	Phone: 716.882.0701, ext. 106Fax: 716.882.0706 FaxEmail: kselover@smartpillcorp.com
Contact Person:	Kathleen H. SeloverVice President, Regulatory Affairs and QualityAssurance
Device Trade Name:	SmartPill GI Monitoring System, version 2.0
Device Common Name:	Gastrointestinal Motility System, Capsule
Trade/Device NameRegulatory Class RegulationNumberProduct codePredicate Device(s)	SmartPill GI Monitoring System, version 2.0UnclassifiedNoneNYVSmartPill GI Monitoring System and pH.p Capsule,version 1.2Konsyl Sitzmarks
ProductDescription	The SmartPill GI Monitoring System senses and records pHand pressure measurements from the entire length of thegastrointestinal tract for use by physicians to aid in theevaluation of gastrointestinal motility diseases and conditions.Sensors on board an ingestible capsule measure pH andpressure as the capsule travels the length of the GI tract.Measurements are transmitted from the capsule within the GItract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC foranalysis and review. MotiliGIT™ Software performs dataanalyses automatically and provides the physician with aprintable report containing regional gut transit times:GET - Gastric emptying (transit) timeSBTT - Small bowel transit timeSLBTT - Combined small and large bowel transit timeCTT - Colonic transit timeWGTT - whole gut transit time
Intended UseIndications for Use	The SmartPill GI Monitoring System measures whole gut andregional gut (stomach, small bowel, and colon) transit times.Measurements of gastrointestinal tract transit times are usedfor evaluating motility disorders.Gastric transit time (gastric emptying time, GET) is indicatedfor the evaluation of patients with suspected gastroparesis.Delayed gastric emptying is implicated in such disorders asidiopathic and diabetic gastroparesis and functional non-ulcerdyspepsiaColonic transit time (CTT) is indicated for the evaluation ofcolonic transit in patients with chronic constipation and usedto aid in differentiating slow and normal transit constipation.Combined small and large bowel transit time (SLBTT) is usedas a surrogate measure of colonic transit in patients withchronic constipation when colonic transit time alone cannotbe determined.The System measures pH, pressure, and temperaturethroughout the GI tract. Pressure contraction data from theantrum and duodenum can be used to calculate motilityindices.Not for use in pediatric patients.
Physical andTechnical Comparisons	Comparison to SmartPill GI Monitoring System: Version 2.0 of thesystem is similar to Version 1.1; differences include anenhanced user interface for reviewing and analyzing the testand an expanded indications for use. Technical features of thetwo devices are, the same.Comparison to Sitzmarks: Version 2.0 of the system is technicallydifferent from Sitzmarks, however, the two devices share theindication for use of measuring and using colonic transit timeto evaluate patients with chronic (severe) constipation.
PerformanceSummary	The performance of the SmartPill GI Monitoring System wastested in multiple bench tests to verify the accuracy andprecision of the device. In addition, clinical testing wasconducted to validate the device's indications for use. Resultsof these tests support the product's intended use, indicationsfor use, performance and clinical claims.
Safety Testing
Biocompatibility	All patient contacting materials were tested forbiocompatibility in accordance with ISO-10993, Part I for asurface device that contacts breached or compromisedsurfaces for prolonged contact and plastic materials inaccordance with USP <661>. Results of biocompatibilitytesting indicate that patient contacting materials are non-sensitizing, non-toxic, and non-irritating when used asdirected.
Electrical Safety	Electrical safety was conducted and the system found to meetthe requirements of IEC 60601-1
ElectromagneticCompatibilityClinical PerformanceTesting	EMC testing was tested and the system found to meet the requirements of IEC 60601-1-2 Two prospective clinical studies were performed with the device. The first study established cutoff values for colonic and combined small large bowel transit time and the second study validated the cutoff values in symptomatic constipated patients.

SmartPill GI Monitoring System and pH.p Capsule, version 2.0 is substantially equivalent to SmartPill GI Monitoring System, version 1.2 and Konsyl Sirzmarks.

{4}------------------------------------------------

{5}------------------------------------------------

SMARTPILL CORPORATION . 510(K) SUBMISSION - SECTION 5 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).