The Mercy TAPE device (2D and 3D models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).

The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.

Device Description

The Mercy TAPE Device (2D and 3D Models) consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. The markings correspond to the validated Mercy Method (calculation algorithm) for determining pediatric body weight using humeral length and mid-upper arm circumference.

The Mercy TAPE Device 2D Model consists of a single strip of tape that is used in two (2) stages to measure humeral length and mid-upper arm circumference. For the Mercy TAPE Device 3D Model, two (2) perpendicular strips of tape are designed to be joined into a sliding "T" shape so that humeral length and mid-upper arm circumference can be measured.

AI/ML Overview

The provided text describes the Mercy TAPE device, which estimates pediatric patient body weight using linear measurements. While the document mentions clinical studies and a human factors/usability study, it does not explicitly define acceptance criteria in a quantifiable manner (e.g., "The device must achieve an accuracy of X% within Y kg"). Instead, it broadly states that "the device shows acceptably small variability from true weight with minimal bias" and that "the estimated weights generated by the Mercy TAPE Device (2D and 3D Models) are more accurate than the weights returned with existing weight estimation strategies."

It also states that the device was "validated against a mechanical scale to demonstrate equivalent performance," but the specific metrics and thresholds for this equivalence are not provided.

Therefore, I will extrapolate the "acceptance criteria" based on the general statements of acceptable performance and the study's conclusions, and then provide the reported performance based on the descriptions of the clinical studies.

Here's the information structured as requested, with details extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explicit quantitative acceptance criteria were not stated, these are inferred from the study's conclusions regarding acceptable performance and equivalence.

Aspect	Inferred Acceptance Criteria (not explicitly stated)	Reported Device Performance
Accuracy / Variability	Acceptably small variability from true weight with minimal bias.	"The device shows acceptably small variability from true weight with minimal bias."
Comparative Accuracy	More accurate than existing weight estimation strategies.	"The estimated weights generated by the Mercy TAPE Device (2D and 3D Models) are more accurate than the weights returned with existing weight estimation strategies."
Ease of Use (Usability)	No significant differences in subjective determinations for ease of use compared to existing strategies.	"Our human factors/usability analyses reveal no significant differences in subjective determinations for ease of use between the Mercy TAPE Device (2D and 3D Models) and existing weight estimation strategies."
Critical Task Errors (Usability)	Frequency of critical task errors similar to or lower than standard medical equipment.	"The critical task errors observed with the Mercy TAPE Device (2D and 3D Models) occur with a frequency similar to or lower than the error rates observed with standard medical equipment (e.g., scales, stadiometers, and tape measures)."
Equivalence to Mechanical Scale	Equivalent performance to a mechanical scale for weight estimation (no specific metrics provided).	"The Mercy TAPE Device (2D and 3D Models) ... has been validated against scales that use mechanical strain or balance methods to obtain an estimate of body weight." and "was validated against a mechanical scale to demonstrate equivalent performance."

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

The document describes several clinical studies. It seems the "clinical studies" mentioned in Section H encompass both the algorithm development/validation and a separate human factors study.

Algorithm Validation (Test Set):
- Sample size: 1,938 datasets
- Data Provenance: Not explicitly stated for the validation set, but the underlying algorithm was developed using data from the National Health and Nutrition Examination Survey (NHANES) database. NHANES data is collected in the United States, so the provenance is likely United States.
- Retrospective/Prospective: The use of "datasets" from NHANES suggests a retrospective analysis of existing data for algorithm development and validation.
Human Factors/Usability Study (Test Set):
- Sample size: 1,412 assessments (performed by healthcare providers). This implies that a number of pediatric patients were assessed multiple times. The exact number of unique "patients" in this study is not specified, but the number of "assessments" is 1,412.
- Data Provenance: Not specified, but given the context of Children's Mercy Hospital in Kansas City, MO, it is likely United States.
- Retrospective/Prospective: These were active "assessments" comparing the device to other strategies, so this was likely a prospective study.

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

The document does not specify the number or qualifications of experts used to establish ground truth for either the algorithm validation or the human factors study.
The ground truth for weight was established using "scales that use mechanical strain or balance methods" for comparison, which implies a direct measurement, not an expert consensus for the "true weight."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The ground truth appears to be based on objective measurements (mechanical scales), removing the need for expert adjudication.

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

Yes, a MRMC-like study was done in the context of the human factors/usability study.
The human factors study evaluated "front-line" healthcare providers (ED nurses and first responders) comparing the Mercy TAPE device against five other weight estimation strategies. This involves multiple "readers" (healthcare providers) evaluating cases (presumably pediatric patients).
Effect size of how much human readers improve with AI vs without AI assistance: The document states that the Mercy TAPE device yielded "more accurate" estimated weights than existing strategies, even when factoring in errors and close-calls. However, it does not provide a specific quantitative effect size (e.g., percentage improvement in accuracy, reduction in error margin) for this improvement.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The "clinical studies" section states: "Clinical studies were conducted to evaluate the predictive performance of the Mercy TAPE Device (2D and 3D Models) and their equivalence to the underlying Mercy Tape method algorithm." This primarily refers to the algorithm's performance in estimating weight.
This performance was described as showing "acceptably small variability from true weight with minimal bias."

7. Type of Ground Truth Used

The ground truth used for weight estimation was direct measurement from mechanical scales (e.g., "scales that use mechanical strain or balance methods"). This is an objective measurement, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The Mercy Tape method algorithm was developed using "demographic and anthropometric data on 17,328 individual children." This represents the training/development set.

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

The ground truth for the training set (17,328 children) was established using data from the National Health and Nutrition Examination Survey (NHANES) database. NHANES collects comprehensive health and nutrition data, which includes anthropometric measurements and likely objective weight measurements, establishing the ground truth for algorithm development.

Summary

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

May 1, 2015

Children's Mercy Hospital c/o Mr. Jan S. Peterson The EMMES Corporation 401 N Washington Street, Suite 700 Rockville, MD 20850

Re: K142469

Trade/Device Name: Mercy TAPE Device (2D and 3D Models) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: I Product Code: PIR Dated: March 31, 2015 Received: April 1, 2015

Dear Mr. Peterson:

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K142469

Device Name Mercy TAPE device (2D and 3D models)

Indications for Use (Describe)

The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.

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

2 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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6. 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.87(h).

A. Submitter's Information

Name:	Susan Abdel-Rahman, PharmD
Address:	Professor of PediatricsDivision of Clinical Pharmacology and Medical ToxicologyChildren's Mercy Hospital2401 Gilham Road, RB 3730.06Kansas City, MO 64108-4619
Phone:	816-234-3059
Fax:	816-855-1958
E-mail:	srahman@cmh.edu
Correspondent:	Jan S. Peterson, MS, CCRA, RACThe Emmes Corporation401 N. Washington Street, Suite 700Rockville, MD 20850-1785301-251-1161jpeterson@emmes.com
Date of Summary:	April 30, 2015

B. Device Information

Device Name:	Mercy TAPE Device (2D and 3D Models)
Regulation Number:	21 CFR 878.4800
Regulation Name:	Manual surgical instrument for general use, Tape Measure
Regulatory Class:	I
Product Code:	PIR
Panel:	General Hospital

C. Predicate Device Information

Manufacturer:	Pfizer, Inc.
Product Name:	Tape Measure
510(k) Number:	K790089
Product code:	FTY
Regulation Number:	878.4800

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D. Reference Devices

a) Scale, Stand-on, Patient

Manufacturer:	SR Instruments Inc.
Product Name:	Daily-weight
510(k) Number:	K770848
Product code:	FRI
Regulation Number:	880.2700

b) Scale, Patient

Manufacturer:	U.S. Medical Corp
Product Name:	U.S. Medical PS-2000 Pediatric Scale
510(k) Number:	K910582
Product code:	FRW
Regulation Number:	880.2720

E. Device Description

F. Intended Use

The Mercy TAPE Device (2D and 3D Models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE Device for humeral length (HL, for the 2D Model) or half-humeral length (HHL, for the 3D Model) and the mid-upper arm circumference (MUAC).

The Mercy TAPE Device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.

Rx only.

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	G. Summary of comparison with predicate device and reference devices
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Attribute	Mercy TAPEDevice (2D and 3DModels)	Predicate device:Tape Measure(K790089)Product CodeFTY	Reference device:Stand-on PatientScale (K770848)Product Code FRI	Reference device:Patient Scale(K910582)Product CodeFRW
Intended Use	The Mercy TAPEDevice (2D and 3DModels) areintended to be usedfor estimating theweight of apediatric patient bymeasuring thelength of specificbody parts	A tape measure is adevice intended tobe used in variousgeneral surgicalprocedures formeasuring length ofparts of the body	A stand-on patientscale is a deviceintended formedical purposesthat is used toweigh a patientwho is able to standon the scaleplatform	A patient scale is adevice intended formedical purposesthat is used tomeasure the weightof a patient whocannot stand on ascale.
Use for generaluse	Yes	Yes	Yes (when patientcan stand)	Yes
Anthropometricmeasurement	Yes	Yes	Yes	Yes
Lengthmeasurement ofbody part	Yes, converted toweight	Yes	No	No
WeightDetermination	Yes, based uponmeasured length ofbody parts	No	Yes	Yes
Weightdeterminationmethod	Indirect	No	Direct	Direct
Output Display	View markings ondevice and addindicated values	View markings ondevice	View displayindicator on device	View displayindicator on device
RequiresElectricalPower	No	No	Optional	Optional
Hand-manipulateddevice	Yes	Yes	Optional	Optional
Reusable	Labeled for SinglePatient Use	Yes	Yes	Yes

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H. Performance Evaluation - Clinical Testing

Clinical studies were conducted to evaluate the predictive performance of the Mercy TAPE Device (2D and 3D Models) and their equivalence to the underlying Mercy Tape method algorithm. Non-clinical studies were not performed. In the clinical studies, the device shows acceptably small variability from true weight with minimal bias. The Mercy Tape method algorithm was developed using demographic and anthropometric data on 17,328 individual children 2 months to 16 years of age from the National Health and Nutrition Examination Survey (NHANES) database. In addition, 1,938 datasets were used for method validation.

A separate human factors/usability study was also conducted utilizing the Mercy TAPE Device (2D and 3D Models) to examine the speed, accuracy and precision with which "front-line" health care providers could apply the Mercy TAPE Device (2D and 3D Models). The study included emergency department (ED) nurses and first responders who conducted 1,412 assessments comparing the Mercy TAPE Device (2D and 3D Models) to all five of the most common weight estimation strategies, including visual estimation, Advanced Pediatric Life Support (APLS) calculation, Broselow Tape, Devised Weight Estimation Method, and the Luscombe and Owens formula. Our human factors/usability analyses reveal no significant differences in subjective determinations for ease of use between the Mercy TAPE Device (2D and 3D Models) and existing weight estimation strategies. In addition, the critical task errors observed with the Mercy TAPE Device (2D and 3D Models) occur with a frequency similar to or lower than the error rates observed with standard medical equipment (e.g., scales, stadiometers, and tape measures). Importantly, even when factoring in errors and close-calls, the estimated weights generated by the Mercy TAPE Device (2D and 3D Models) are more accurate than the weights returned with existing weight estimation strategies.

I. Comparison to the Predicate Device and Conclusion

The Mercy TAPE Device (2D and 3D Models) shares certain common features with the predicate comparator device, namely the simple tape measure, in that it assesses simple anthropometric measurements. The Mercy TAPE Device (2D and 3D Models), however, provides an estimation of body weight based on an algorithm that is unique to the device. The Mercy TAPE Device (2D and 3D Models) uses linear anthropometric body measurements to derive estimated body weight, and this has been validated against scales that use mechanical strain or balance methods to obtain an estimate of body weight. The clinical testing indicates that the Mercy TAPE Device (2D and 3D Models) is substantially equivalent to the predicate comparator device and was validated against a mechanical scale to demonstrate equivalent performance.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.