G-Tech Wireless Patch System (WPS) by G-Tech Medical

The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.

Device Description

The G-Tech System is a non-invasive wireless gastrointestinal monitoring system for use by the physician or staff in the hospital setting, clinic, or physician's office. The device is intended for use while the patient is under direct supervision (e.g., in hospital or clinic) as well as after discharge to home or to intermediate setting. The device is for prescription use only. The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS application, a secure cloud storage server and computer-based data analysis algorithms. The G-Tech Patch is a single use, wearable electrode patch that reads the electrical signals of the gastrointestinal tract from the abdominal skin surface. The Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch Monitor. The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient interface to allow the patient to manual enter events such as meals, bowel movements, pain or the taking of medications. Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines. These measurements are made available to physicians for aid in clinical evaluation of their patient.

AI/ML Overview

The provided document describes the G-Tech Wireless Patch System (WPS), a non-invasive device for measuring gastrointestinal myoelectrical activity. The information details the device's characteristics, intended use, and substantial equivalence to predicate devices, through various studies. However, the document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding reported device performance values in a table. It also does not present a traditional "study" in the sense of a clinical trial with a defined test set, ground truth experts, adjudication, or MRMC design for regulatory clearance.

Instead, the submission focuses on demonstrating substantial equivalence through a combination of:

Bench Performance Study: Functional testing with known signals to assess the system's ability to extract rhythmic motor activity.
Animal Study: Comparison of G-Tech Wireless Patches with internal electrodes in mini-pigs to show fidelity of surface-measured signals to internal ones.
Clinical Studies (Primary Evidence): Simultaneous measurements with manometry and Smart Pill to demonstrate concordance in frequency and time of myoelectrical activity with internal measurements. These appear to be more akin to validation or correlation studies rather than a pass/fail performance study against pre-defined acceptance criteria for diagnostic accuracy.
Supplemental Evidence: Four peer-reviewed publications demonstrating correlation with clinical markers and reproducibility.

Given the information provided, I will interpret "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of the available data, which focuses on demonstrating substantial equivalence through various aspects of performance and comparison to established methods, rather than a single, pre-defined algorithm performance study with specific cutoffs.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not provide a quantitative table of acceptance criteria with corresponding reported device performance values for the overall device's diagnostic capability (e.g., sensitivity, specificity for a specific disorder). The "acceptance criteria" for this 510(k) submission appear to be implicit and qualitative: demonstrating that the device performs as intended, is safe, and is substantially equivalent to predicate devices.

The "performance" is described broadly:

Aspect	Implicit "Acceptance Criteria" (Demonstrated)	Reported Device Performance (as described in the text)
Functional Performance	Reliable and consistent electrical measurement; efficient extraction of rhythmic motor activity signals.	Bench Performance Study demonstrated: - G-Tech Patches are reliable and provide consistent electrical measurement devices. - Data processing algorithms are efficient engines for extracting rhythmic motor activity signals.
Fidelity to Internal Signals	Detectable slow wave signals at the skin surface (stomach, small intestine, colon) with fidelity to internally measured signals in frequency and spectral shape.	Animal Study demonstrated: - Slow wave signals associated with the three major GI organs (as observed with internal electrodes) are detectable at the skin surface with the G-Tech Wireless Patches. - Signals have fidelity to the internally measured signals in frequency and spectral shape.
Clinical Concordance	Records signals identifiable as originating from Stomach, Duodenum/Jejunum, and Colon, with concordance to manometry and Smart Pill data.	Clinical Studies (Primary Evidence) demonstrated: - Non-invasive patch system records signals identifiable as being from the Stomach, Duodenum/Jejunum, and Colon by concordance with frequency and time of spectral analysis of high-resolution manometry data. - Concordance in frequency and time observed between G-Tech Wireless Patch measurements and Smart Pill measurements.
Clinical Utility/Correlation	(Implicit) Utility in understanding measurement capabilities and potential clinical use; correlation with clinical markers of postoperative recovery; reproducibility; sensitivity to external stimulus.	Clinical Studies (Supplemental Evidence - Peer-Reviewed Publications) demonstrated: - Correlation between G-Tech Wireless Patch Measurements and clinical markers of postoperative recovery in adult and pediatric populations. - Reproducibility of the gastric and intestinal myoelectrical profile over multi-year periods. - Sensitivity of measurements to an external stimulus in specific examples.
Safety	Electrical safety, EMC, biocompatibility, mechanical strength.	Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-2, ANSI C63.27-2017. Biocompatibility assessed with ISO 10993-1:2009 (compliant for intact skin up to 30 days). Mechanical strength testing (wear adhesion, tensile, impact, drop, shock, vibration) demonstrates performance as intended and safety.
Software Performance	Software acquires and processes myoelectrical signals, generates reports as intended.	Software documentation developed in consideration of "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices". (Implies verification and validation were done to meet these guidelines).

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

The document does not explicitly define a "test set" in the context of an AI/ML model for a diagnostic study, but rather describes various validation/correlation studies.

Bench Performance Study: Known signals were applied to the system, but the specific number/type of signals is not quantified as a "sample size."
Animal Study: Data from "a study" undertaken to compare measurements in "adolescent Yucatan mini-pigs." The number of animals is not specified. Data provenance: likely laboratory/research setting (not specified country).
Clinical Studies (Primary Evidence): Describes "simultaneous measurements between G-Tech Wireless Patches and antroduodenal and colonic manometry" and "concordance... between G-Tech Wireless Patch measurements and Smart Pill measurements." The number of human subjects/patients involved in these "primary evidence" studies is not specified. Data provenance: "IRB-approved studies and well-documented case histories," implying prospective or retrospective for specific cases. Country of origin is not specified, but the applicant is US-based.
Clinical Studies (Supplemental Evidence - Peer-Reviewed Publications): These are external studies. The document only lists the publications without detailing their sample sizes or methodology beyond their titles. To get this info, one would need to refer to the publications themselves.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the device's performance appears to be established through:

Known signals (bench testing).
Internal electrodes (animal study).
Established clinical methods like manometry and Smart Pill (clinical studies).

There is no mention of human expert consensus or adjudication being used as a "ground truth" reference for this device's output. The device provides "measurements" to be used at the "discretion of the Physician or Clinical User," suggesting the physician interprets the device's data rather than the device providing a definitive "diagnosis."

4. Adjudication Method for the Test Set

This information is not applicable/provided. No "test set" in the context of expert review with adjudication is described.

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

This information is not provided and such a study design is not described for this device. The G-Tech WPS provides "measurements" for physicians to use in their diagnosis; it is not described as an AI-powered diagnostic aid that re-interprets medical images or provides a direct diagnostic output that a human then uses. Therefore, a study on human reader improvement with/without AI assistance isn't relevant to the information presented for this device.

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

The document states: "Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines." The "Bench Performance Study" and "Animal Study" would represent aspects of standalone algorithm performance, as they assess how well the system, through its algorithms, extracts and measures signals compared to known inputs or internal direct measurements.

Bench Performance Study: Confirmed algorithms are "efficient engines for extracting rhythmic motor activity signals."
Animal Study: Confirmed surface signals "have fidelity to the internally measured signals in frequency and spectral shape."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The types of "ground truth" or reference standards used are:

For Bench Testing: Known, synthetic electrical signals with realistic background, artifact, and noise characteristics.
For Animal Study (Fidelity): Simultaneous measurements using "multi-element electrodes sutured to serosal surfaces of stomach, small intestine, and colon." (i.e., direct internal physiological measurements).
For Clinical Studies (Concordance):
- High-resolution manometry data (for antroduodenal and colonic myoelectrical activity).
- Smart Pill measurements (for gastrointestinal transit and related activity).
For Clinical Utility/Correlation (Supplemental Evidence): Clinical markers of postoperative recovery.

8. The Sample Size for the Training Set

This information is not provided. The document describes the device as a measurement system, not a machine learning model developed with explicit training and test sets in the typical AI/ML sense (though data analysis algorithms are present). If the algorithms involved machine learning, the training set details would be critical, but they are not mentioned here.

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

This information is not provided, as details regarding a specific "training set" are absent.

Summary of Missing Information critical for a typical AI/ML Diagnostic Study:

Quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
Sample sizes for human clinical "test sets."
Details on expert involvement, qualifications, and adjudication methods for any human interpretation studies.
MRMC study results for human-AI collaboration.
Explicit training set details, including size and ground truth establishment, for the data analysis algorithms (if they are AI/ML-based algorithms requiring such, which is not explicitly stated).

The provided text focuses on the device's technical performance (signal acquisition, processing, safety) and its correlation/concordance with existing physiological measurement techniques, supporting its claim of substantial equivalence as an electrogastrography system.

Summary

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January 10, 2022

G-Tech Medical Steve Axelrod President and CEO 2495 Hospital Drive, Suite 300 Mountain View, CA 94040

Re: K212954

Trade/Device Name: G-Tech Wireless Patch System (WPS) Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography System Regulatory Class: Class II Product Code: MYE Dated: September 14, 2021 Received: September 16, 2021

Dear Steve Axelrod:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212954

Device Name The G-Tech Wireless Patch System (WPS)

Indications for Use (Describe)

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)

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K212954 Page 1 of 4

510(k) Summary

This summary of the 510(k) premarket notification for the G-Tech Patch System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Date:	Jan 7, 2022
Applicant:	G-Tech Medical, Inc.2495 Hospital Drive, Suite # 300Mountain View, CA 94040Phone: 650-269-1479Fax: N/A
ApplicantContact Person:	Steve Axelrod, PhDPresident and CEO, G-Tech Medical, Inc.2495 Hospital Drive, Suite # 300Mountain View, CA 94040Phone: 650-269-1479Fax: N/AEmail: steve.axelrod@gtechhealth.com
DeviceInformation	Trade Name: The G-Tech Wireless Patch System (WPS)Generic/Common Name: Gastrointestinal myoelectrical activity measurementsystemRegulation: 21 CFR 876.1735Classification: Electrogastrography (EGG) systemProduct Code: MYE
PredicateDevice(s)	Primary predicate device #1: DEN990005 / K984637, THE 3CPM EGGMACHINEPredicate device #2: K014269, Polygram Net Electrogastrography ApplicationSoftware, Model 9043S0151; Polygraf Id, Model 9043G0102Reference device: K092342, Smartpill GI Monitoring System, Version 2.0.
Intended Use	The intended use for the G-Tech Patch System is to serve as a tool that providesgastric and intestinal myoelectrical activity measurements to be used at thediscretion of the Physician or Clinical User to aid in the diagnosis and evaluationof gastrointestinal disorders.
DeviceDescription	The G-Tech System is a non-invasive wireless gastrointestinal monitoring systemfor use by the physician or staff in the hospital setting, clinic, or physician'soffice. The device is intended for use while the patient is under direct supervision
	(e.g., in hospital or clinic) as well as after discharge to home or to intermediatesetting.
	The device is for prescription use only.
	The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOSapplication, a secure cloud storage server and computer-based data analysisalgorithms.
	The G-Tech Patch is a single use, wearable electrode patch that reads theelectrical signals of the gastrointestinal tract from the abdominal skin surface. ThePatch transmits the acquired electrical signals via Bluetooth to the G-Tech PatchMonitor.
	The G-Tech Patch Monitor receives the raw data, encrypts it, and periodicallyuploads it to a secure cloud server. Additionally, the Patch Monitor has a patientinterface to allow the patient to manual enter events such as meals, bowelmovements, pain or the taking of medications.
	Data analysis algorithms process the uploaded data to measure and reportmyoelectrical activity for the stomach and intestines. These measurements aremade available to physicians for aid in clinical evaluation of their patient.
Determination ofSubstantialEquivalence:	Indications for Use: The G-Tech Wireless Patch System and the predicate devicehave the same indications for use and same intended population.
	Technology: The G-Tech WPS operates on the same fundamental principal as thepredicate system by measuring myoelectrical activity with cutaneous electrodes atthe abdominal skin surface. Technological improvements in the G-Tech WPSthat improve on the predicate system have been evaluated to ensure that the safetyand efficacy profile of the predicate device is maintained for the G-Tech PatchSystem.
	Electrical safety and electromagnetic compatibility (EMC): Electrical safetyand EMC testing were conducted on the G-Tech Wireless Patch System. The G-Tech Wireless Patch System complies with the following standards
	• IEC 60601-1:2005
	• IEC 60601-1-11:2015
	• IEC 60601-1-6:2010
	• IEC 60601-1-2:2014
	• ANSI C63.27-2017
	Biocompatibility: The biocompatibility of the G-Tech Patch System wasassessed by evaluating the results of the testing recommended by ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testingwithin a risk management. The G-Tech Patch has been assessed to be compliantfor contact with intact skin for up to 30 days.

510(k) Notification K212954

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Software Verification and Validation Testing: The G-Tech Patch System uses software to acquire and process the myoelectrical signals and generate a report for the Physician. Software documentation for the G-Tech Patch System was developed in consideration of FDA's guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices" and is provided.

Mechanical Strength Testing: Mechanical Strength testing that includes wear adhesion test and tensile strength test are presented. Additionally, impact test, drop test and shock and vibration tests, conducted for compliance to 60101-1-11 that assesses requirements of medical electrical equipment for Home Healthcare, is presented. The testing demonstrates that the G-Tech Wireless Patch System device should perform as intended in the specified use conditions and maintain the safety profile of the predicate system.

Bench Performance Study: Functional bench testing performed to demonstrate the performance and efficiency of the patch system and algorithms that calculate myoelectrical activity of the Stomach and Intestines are presented. Known signals that have realistic background, artifact and noise characteristics to the system were applied to the system both directly and through a phantom, to assess how the system will perform when the signals are real and not known a priori. The study demonstrated that the G-Tech Patches are reliable and provide consistent electrical measurement devices, and that the data processing algorithms are efficient engines for extracting rhythmic motor activity signals.

Animal Study: Data from a study undertaken to compare simultaneous measurements between G-Tech Wireless Patches and multi-element electrodes sutured to serosal surfaces of stomach, small intestine, and colon of adolescent Yucatan mini-pigs is presented. The data demonstrate that the slow wave signals associated with the three major GI organs as observed with internal electrodes are detectable at the skin surface with the G-Tech Wireless Patches and have fidelity to the internally measured signals in frequency and spectral shape.

Clinical Studies: G-Tech Medical has studied its technology under several nonsignificant risk IRB-approved studies and well-documented case histories. These studies have focused on understanding the measurement capabilities and potential clinical utility of the technology.

The primary evidence includes simultaneous measurements between G-Tech Wireless Patches and antroduodenal and colonic manometry that demonstrates that the non-invasive patch system records signals that can be identified as being from the Stomach, Duodenum/Jejunum and Colon by the concordance with frequency and time, of spectral analysis of high-resolution manometry data. Similarly, concordance in frequency and time observed between G-Tech Wireless Patch measurements and Smart Pill measurements is presented that corroborates the findings from the manometry study.

The supplemental evidence provided are four peer-reviewed publications listed below. Three of these demonstrate correlation between the G-Tech Wireless Patch Measurements and clinical markers of postoperative recovery in adult and

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	pediatric populations. A fourth peer reviewed publication demonstratesreproducibility of the gastric and intestinal myoelectrical profile over multi-yearperiods and the sensitivity of the measurements to in external stimulus in specificexamples.
	1. Dua, M.M., Navalgund, A., Axelrod, S., Axelrod, L., Worth, P.J., Norton,J.A., Poultsides, G.A., Triadafilopoulos, G. and Visser, B.C., 2018.Monitoring gastric myoelectric activity after pancreaticoduodenectomyfor diet "readiness”. American Journal of Physiology-Gastrointestinal and Liver Physiology , 315(5), pp. G743-G751.
	2. Navalgund, A., Axelrod, S., Axelrod, L., Singhal, S., Tran, K., Legha, P.,& Triadafilopoulos, G. (2019). Colon myoelectric activity measured afteropen abdominal surgery with a noninvasive wireless patch systempredicts time to first flatus. Journal of Gastrointestinal Surgery , 23(5),982-989.
	3. Taylor, J.S., de Ruijter, V., Brewster, R., Navalgund, A., Axelrod, L.,Axelrod, S., Dunn, J.C. and Wall, J.K., 2019. Cutaneous Patches toMonitor Myoelectric Activity of the Gastrointestinal Tract inPostoperative Pediatric Patients. Pediatric gastroenterology, hepatology & nutrition , 22(6), pp.518-526.
	4. Axelrod, L., Axelrod, S., Navalgund, A. and Triadafilopoulos, G., 2020.Pilot Validation of a New Wireless Patch System as an Ambulatory,Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologicand Disease Correlations. Digestive Diseases and Sciences , pp.1-11.
Conclusion:	The G-Tech Patch System and the predicate device have the same indications foruse. Technological improvements in the G-Tech WPS that expand the utility ofthe predicate device have been evaluated to ensure that the safety and efficacyprofile of the predicate device is maintained for the G-Tech Patch System.The biocompatibility, electrical and electromagnetic testing and hardware testingsupport the safety of the device. The clinical data supports the safety and theability of the G-Tech Wireless Patch System to measure not just gastric but alsointestinal myoelectrical activity. The bench testing, hardware and softwareverification and validation demonstrate that the G-Tech Wireless Patch Systemdevice should perform as intended in the specified use conditions. Therefore, it isthe conclusion of G-Tech Medical that the G-Tech Patch System is substantiallyequivalent to the predicate device.

Regulation Number and Section

§ 876.1735 Electrogastrography system.

(a)
Identification. An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.(b)
Classification. Class II (Special Controls). The special controls are as follows:(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) The labeling must include specific instructions:
(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;
(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;
(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and
(iv) To explain how data results may be interpreted.
(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.
(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.