The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) to which it is connected.

Device Description

The DataCaptor™ System consists of DataCaptor™ Connectivity Software a data acquisition system designed to retrieve and deliver near-real-time data from multiple vendors' bedside medical devices and send it to clinical or hospital information systems in HL7 standard format; Capsule Neuron™ with Docking Station (for high acuity environments) or Mini-Dock (for low acuity environments), a bedside hardware platform for device connectivity, and the Datack (1017 Terminal Server, a Serial-to-Ethernet concentrator for the medical environment that connects RS-232 equipped bedside medical devices to the hospital network for safe transmission of the clinical or hospital information system.

AI/ML Overview

This appears to be a 510(k) summary for a medical device called the DataCaptor™ System. It's important to note that a 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel clinical effectiveness through extensive performance studies like those required for a PMA (Premarket Approval).

Therefore, the type of detailed "study that proves the device meets the acceptance criteria" as typically understood for AI/ML devices (with metrics, sensitivity/specificity, reader studies, etc.) is not present in this document. This document primarily describes design changes and verification/validation activities to ensure the modified device performs comparably to its predicate.

Here's an analysis of the provided text in response to your questions:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification and validation activities to pre-determined pass/fail criteria were based on results of risk an alres va confirm system performance, functionality and reliability to be commensurate to the predicate device."

However, no specific quantitative acceptance criteria or reported device performance data (e.g., in terms of accuracy, precision, or error rates for data collection) are provided in a table format in this public summary. The focus is on demonstrating that the modified DataCaptor™ System performs commensurately to the predicate device. This is typical for a Special 510(k), which deals with modifications to a previously cleared device.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Design verification and validation activities," implying testing was conducted. However, no specific sample sizes for a test set, data provenance (country of origin), or whether the data was retrospective or prospective are mentioned. This level of detail is typically not included in a 510(k) summary, as the emphasis is on confirming that the system itself functions as intended, not necessarily on its performance with a specific dataset of clinical outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This device is a data collection system, not an AI/ML diagnostic or assistive tool that would require expert-established ground truth on clinical images or patient conditions. Its "performance" refers to its ability to accurately retrieve and transmit data from medical devices. The verification and validation activities would focus on the technical integrity of data transfer, not on clinical interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, the device's function does not involve clinical interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a data connectivity solution, not an AI-powered assistive tool for human readers. Therefore, an MRMC study is irrelevant to its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The DataCaptor™ system is described as "a data acquisition system designed to retrieve and deliver near-real-time data from multiple vendors' bedside medical devices and send it to clinical or hospital information systems." Its performance is inherent in its ability to correctly acquire and transmit data. While it operates "standalone" in capturing data, its "performance" is about technical accuracy and reliability of data transfer, not about a standalone clinical interpretation task. The document states it is "not intended for monitoring purposes, nor is the software intended to control any of the clinical devices." This reinforces that its performance is not a clinical "standalone" assessment in the way AI diagnostics are evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a data collection system, the "ground truth" would likely involve:

Verification of data integrity: Comparing the data captured by DataCaptor™ to the raw data output directly from the bedside medical devices (e.g., via a controlled test environment or direct measurement).
Verification of data transmission: Ensuring the data is correctly formatted and transmitted to the clinical information systems (HL7 standard).
System functionality testing: Ensuring all software and hardware components operate as designed.

No specific methodology for establishing this "ground truth" (e.g., expert consensus) is outlined in the summary, as it's a technical verification process rather than a clinical one.

8. The sample size for the training set

The DataCaptor™ System is a software and hardware system for data collection, not an AI/ML model that would be "trained" on a dataset in the typical sense. Therefore, there is no "training set" or corresponding sample size.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary of what can be gleaned about "acceptance criteria" and "study" from this document:

Acceptance Criteria (Implied): The central acceptance criterion for this Special 510(k) was that the modified DataCaptor™ System would continue to demonstrate "substantial equivalence" to its predicate device. This means its performance, functionality, and reliability should be "commensurate" with the previously cleared device, and it should meet its intended use of data collection and clinical information management without being used for monitoring or control of devices.
Study (Verification/Validation Activities): The "study" mentioned is not a clinical trial or performance study in the sense of comparing diagnostic accuracy. Instead, it refers to:
- Software verification and validation: Ensuring the software changes meet specifications and function correctly.
- Environmental and safety testing: For hardware changes.
- System validation: Confirming the overall system performance, functionality, and reliability.
  These activities were designed to ensure the device met "pre-determined pass/fail criteria" derived from a risk analysis, confirming its equivalence to the predicate. Specific details of these technical tests (e.g., number of test cases, types of data simulated) are not provided in this public summary.

In essence, this 510(k) summary focuses on demonstrating that modifications to an existing device do not alter its safety or effectiveness, rather than performing a new clinical efficacy study.

Summary

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510(k) Summary of Safety and Effectiveness

JUN 2 7 2012

C.1 Submitter Information

Submitter:	Contact Name:
Capsule Tech, Inc.300 Brickstone square, Suite 203Andover MA 01810 USA	Peter Kelley,Director, Quality Assurance and Regulatory AffairsCapsule Tech, Inc.Phone: 978-482-2309Fax: 978-482-2980E-mail: peterk@capsuletech.com

C.2 Date Prepared: December 08, 2011

C.3 Name of Device

C.3.1 Trade Name: DataCaptor™ System

C.3.2 Common Name: Data Collection Software

C.3.3 Classification Name, Class, Product Code and Panel

Classification Name and RegulationNumber	Class	Product Code	Panel
Cardiac monitor (includingcardiotachometer and rate alarm) -21 CFR 870.2300	II	MWI	Cardiology

C.4 Substantial Equivalence Claimed to Predicate Device

DataCaptor™ System as cleared via one Traditional 510(k), K013019, and two subsequent Special 510(k)s, K020197, and K032142

C.5 Device Description

િંહ Intended Use and Indications for Use

The DataCaptor™ System is indicated for use in data collection and clinical information

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K113835 P2/2

management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) to which it is connected.

C.7 Technology

The modified DataCaptor™ System employs the same technology as the predicate device based on an assessment of relevant Design Control documentation, which is on file at the manufacturer's facility.

C.8 Performance Data

C.8.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device.
C.8.2 Iest Summary: design changes in software, hardware and system requirements with respect to the DataCaptor™ System were implemented according to Capsule Tech's Design Control program and are described in this Special 510(k). Design verliication and validation activities to pre-determined pass/fail criteria were based on results of risk an alres va confirm system performance, functionality and reliability to be commensurate to the predicate device. The types of design verification and validation activities included software verification and validation of the software changes, environmental and safety testing of the hardware changes, and system validation.

C.9 Conclusion:

The information and data provided in this Special 510(k) Premarket Notification establish that the modified DataCaptor™ System is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines.

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

JUN 2 7 2012

Capsule Tech, Inc. c/o Mr. Peter Kellev Director, Quality Assurance and Regulatory Affairs 300 Brickstone Square, Suite 203 Andover, MA 01810

Re: K113835

Trade/Device Name: DataCaptor™ System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Codes: MWI Dated: April 30, 2012 Received: May 3, 2012

Dear Mr. Kelley:

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.

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

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Page 2 - Mr. Peter Kelley

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix B – Statement of Indications for Use

Statement of Indications for Use

510(k) Number (if known): Unknown

Prescription Use: ________ ਮ AND/OR (21 CFR § 801 Subpart D)

Over-the-Counter Use: (21 CFR §07 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

nsion Sidn Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).