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The "Intended Uses" of the modified 300-2W is exactly the same as the predicate device (model 300-2). The intended use is to acquire, record, and store one or more davs of multi-lead ECG data for patients undergoing continuous ambulatory electrocardiography. The 300-2 performs no cardiac analysis by itself and is intended to be used only with the DMS Premier II Holter system (K062088), as is the predicate 300-2 device.

The "Indications for Use" of the modified DMS 300-2W recorder is indicated for use in a clinical setting by qualified medical professionals only for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. Ambulatory 24-hour electrocardiography is used for the below indications:

• . Evaluation of patients with symptoms suggesting arrhythmias.
• Evaluation of patients with pacemakers. .
• Evaluation of patients heart rate changes.
• . Evaluation of patients QRS interval changes.
• · Evaluation of patients response to drug therapy treatment.

The "Indications for Use" for the modified 300-2W is exactly the same as the predicate 300-2 device.

The 300-2W is a Holter Recorder that records the ECG signal in the exact same manner as the predicate 300-2 device. The 300-2W transfers the Holter ECG from its memory in the exact same manner as the predicate 300-2. The 300-2W uses the same USB cable as is used by the predicate 300-2 to transfer the Holter file from the Holter Recorder to the Holter PC. The Holter PC program processes the 300-2W Holter ECG recording with the exact same software program as is used by the 300-2 predicate device. All of the Holter ECG screen displays and print pages are exactly the same when using either the 300-2W device or the 300-2 predicate device. The Holter report from which the physician makes a diagnosis is the exact same format when using either the 300-2W device or the 300-2 predicate device. The 300-2W uses the same firmware as the predicate 300-2 to record the Holter ECG data and to transfer the Holter recording to the Holter PC. The ECG signal in the 300-2W is the same ECG signal as the predicate 300-2. The Intended Uses of the 300-2W and the predicate 300-2 are the same. The Indications for Use of the 300-2W and the predicate 300-2 are the same. The Design Controls and Performance Standards for the 300-2W and the predicate 300-2 are from the same source processes. The manufacturing process has ISO 13485 certification.

The 300-2W and the predicate 300-2 are multi-day Holter recorders. Both the 300-2W and the predicate 300-2 use the same alkaline or lithium batteries that are off-the-shelf AA batteries. Both the 300-2W and the predicate 300-2 use off-the-shelf commercial memory chips. The 300-2W uses a larger capacity memory chip, and both recorders operate with the memory chip in the same manner. The larger commercial memory chips are now larger capacity and cost less money than 300-2 Holter ECG recorder of 2006. All Holter ECG recorders have auxiliary real-time ECG outputs. These auxiliary outputs have no effect on the safety, performance, Intended Use, or Indications for Use with either the 300-2W or the predicate 300-2. Both the 300-2W and the predicate 300-2 have two (2) auxiliary outputs. The traditional uses of these auxiliary outputs is to view the quality of the electrode application to the patient prior to leaving the doctor's office, or to see the operational ECG of the Holter recording. The 300-2W and the predicate 300-2 have the same USB auxiliary output. The 300-2W has a WiFi auxiliary output and the predicate 300-2 has a transtelephonic auxiliary output.

The provided text describes a Special 510(k) Notification for the DMS 300-2W Holter ECG Recorder, claiming substantial equivalence to its predicate device, the DMS 300-2. This type of submission focuses on minor modifications that do not affect the intended use, safety, or effectiveness of the device. Therefore, the document primarily details the lack of new performance studies because the modified device is considered to have identical performance to the predicate.

Given this, the acceptance criteria and study information typically found in a traditional 510(k) submission for a new device's performance are not present in this document. Instead, the "acceptance criteria" are effectively met by demonstrating that the modifications (larger memory and an additional auxiliary output) do not alter the fundamental characteristics or performance of the ECG recording and transfer process, which aligns with the predicate device that was previously cleared.

Here's a breakdown based on the information available, acknowledging the nature of a Special 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific "acceptance criteria" for performance in the traditional sense (e.g., accuracy, sensitivity, specificity for diagnostic claims) is not explicitly detailed for the 300-2W because its performance is asserted to be identical to the predicate 300-2. The acceptance criteria here are implicitly based on maintaining the same technical specifications and performance characteristics as the predicate.

The document states: "The 300-2W records the ECG signal in the exact same manner as the predicate 300-2 device," and "The ECG signal in the 300-2W is the same ECG signal as the predicate 300-2." "Both the 300-2W and the predicate 300-2 have successfully passed TUV Rheinland CE Test Reports for Holter Recorders." "The enclosed TUV CE Test Report 15030071 001 shows that the 300-2W Holter Recorder passed all the test specifications for EN 60601=1-2:2007."

2. Sample size used for the test set and the data provenance

No specific "test set" in terms of patient ECG data is described or used for this Special 510(k). The evaluation is based on engineering and performance testing against standards, confirming that the modified components do not alter the fundamental ECG signal acquisition or processing. The TUV CE Test Reports (Sections 12 and 13, and document 15030071 001) are mentioned for confirming compliance with electrical safety and EMC standards, which do not typically involve patient data test sets in this context. The provenance of such testing would be from accredited testing laboratories (e.g., TUV Rheinland).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As described above, there is no clinical "test set" requiring ground truth establishment by medical experts for this type of special 510(k). The submission relies on technical conformity to established standards and the assertion of identical performance to a previously cleared device.

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

Not applicable for the same reasons as #3.

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

Not applicable. The device is a Holter ECG recorder, not an AI-assisted diagnostic tool. Its function is to record ECG data, not to perform analysis or integrate with AI for reader improvement.

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

Not applicable. The 300-2W is a hardware device for recording ECGs, and its data is processed by the "Premier II Holter system" (K062088), a separate software component. The 300-2W itself does not perform analysis or have an "algorithm-only" performance to be evaluated.

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

Not applicable, as no clinical performance study involving diagnostic accuracy or clinical outcomes was conducted for this Special 510(k). The "ground truth" for the device's electrical and physical properties is its conformance to engineering standards (e.g., EN 60601=1-2:2007) as verified by testing.

8. The sample size for the training set

Not applicable. The device is a hardware recorder, not a machine learning algorithm that requires a training set.

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

Not applicable for the same reasons as #8.

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The "Indications for Use" of the modified DMS 300-2, 300-3 and 300–4 recorders are indicated for use in a clinical setting, by qualified medical professionals only, for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. The "Intended Uses" of the modified 300-2, 300-3, and 300-4 Holter ECG Recorders are exactly the same as the predicate devices (DMS 300-7 and 300 ECG Recorder).Ambulatory multi-day electrocardiography is used for the below indications:

. Evaluation of patients with symptoms suggesting arrhythmias.

• . Evaluation of patients with pacemakers.
  . Evaluation of patient heart rate changes and QRS interval changes.

. Evaluation of patient response to drug therapy treatment.

The modified DMS 300-2 Holter ECG Recorder is intended for use as a part of a Holter ECG analysis system for continuous and cardiac event monitoring, and is designed to be used with the DMS Premier Holter system. The DMS 300-2 provides three (3) leads of continuous ECG recording. With its memory built into its circuit board, the 300-2 can store up to thirty (30) days of Long-Term Ambulatory ECG, whether it be continuous ECG or patient symptomatic event ECG data. The 300-2 acquires, digitizes, and stores ECG data that can be later analyzed by the Premier Holter system. Short-term, two-minute ECG's can also be phone transmitted from the Holter recorder to a host PC for symptomatic ECG's. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-2. The cardiac data provided by the 300-2 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhvthm patterns.

The modified DMS 300-3 Holter ECG Recorder is intended for use as a part of a Holter analysis system, and is designed to be used with the DMS Premier Holter system. The DMS 300-3 provides three (3) channels of continuous ECG recording. With its memory built into its circuit board, the 300-3 can store up to two (2) days of continuous Holter ECG data. The 300-3 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-3. The cardiac data provided by the 300-3 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.

The modified DMS 300-4 Holter ECG Recorder is intended for use as a part of a Holter analysis system, and is designed to be used with the DMS Premier Holter system. The DMS 300-4 provides twelve (12) leads of continuous ECG recording. With its memory built into its circuit board, the 300-4 can store up to two (2) days of continuous Holter ECG data. The 300-4 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes nre-recorded patient ECG data that has been stored in the DMS 300-4. The cardiac data provided by the 300-4 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.

The provided document is a 510(k) notification for bundling Holter ECG recorders. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and testing results against those criteria in the way a clinical trial would.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly present in this type of regulatory submission. The document relies on comparing specifications and stating that "the same input signals produce the same results in the processing of the ECG data with the same Holter playback device." This implies a functional equivalence test rather than a clinical performance study with predefined accuracy or clinical endpoint targets.

Here's an attempt to answer the questions based on the information available:

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

The document doesn't define explicit acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity for arrhythmia detection) as a clinical study would. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices. The performance is reported by showing that the new devices have identical or improved specifications compared to the predicates and produce the "same results in the processing of the ECG data."

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in terms of patient data. The testing described is functional testing on the devices themselves using "the same input signals." Therefore, there is no mention of a sample size of patients or data provenance (country of origin, retrospective/prospective). This is a technical performance comparison between devices, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this type of submission is the functional output of the predicate device when given standard input signals. Clinical ground truth (e.g., verified diagnoses by experts) is not discussed.

4. Adjudication method for the test set

Not applicable. There's no clinical test set requiring adjudication in the context of this submission. The comparison is against known technical specifications and functional output of the predicate.

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

Not applicable. This submission is for Holter ECG recorders, which are hardware devices for data acquisition, not AI-powered analysis tools. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is for a hardware device, not an algorithm. The device itself is "standalone" in recording ECG data, but the data is then processed by a "Premier Holter system" which is mentioned as part of the overall system. The focus is on the recorder's ability to acquire and store data equivalently.

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

The "ground truth" for the comparison is the known and established functional output and specifications of the legally marketed predicate device (DMS 300-7 Holter ECG Recorder K062007) when subjected to the "same input signals." It's a technical equivalency rather than a clinical ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set is relevant for this hardware submission.

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The "Intended Use" of the Premier 11 software is the same as the predicate devices. The intended use is for evaluation of the recorded ECG for patients who are subject to physician ordered Holter ECG monitoring environments; such as, palpitations, dizziness, chest pains, shortness of breath, pacemaker function, and drug therapy follow-up. The evaluation includes the standard Holter software measurements and reporting of arrhythmia, ST changes, R-R Variability, QRS interval changes, and heart rate trends. The PC computer-generated results do not contain diagnostic interpretation. The data can be edited, and only the qualified physicians are intended to review the ECG data and to make a diagnosis.

The Premier 11 Holter is intended to be used only by physicians, or on the order and supervision of a physician.

Indications For Use:

The indications for use for 24-hour ambulatory ECG for this modified Premier ll software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following:

• . Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age; such as, palpitations.
• . Assessment of risk in patients with or without symptoms or arrhythmia; such as, patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patients with left ventricular dysfunction.
• . Assessment of efficacy of anti-arrhythmic therapy.
• . Assessment of pacemaker function.
• . Detection of transient ST Depression, as well as Prinzmetal ST Elevation.

The Premier 11 Holter is a software program that analyzes recorded ambulatory ECG (Holter), then creates ECG print-outs and numerical reports based on the analyzed data. The ambulatory ECG, as well as pacemaker pulse data, is prerecorded onto data storage mediums by Holter ECG recorders. The Premier 11 Holter software reads these raw data into standard PC computers, and then performs analysis to generate numerical reports.

The Premier 11 Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis of the recorded Holter ECG data. This data processing is performed on a standard PC computer, such as an XP Home or Professional operating platform.

The cardiac data that is processed by the Premier 11 Holter is both individual ECG waveforms and patterns of consecutive ECG waveforms. The Premier 11 Holter software does not provide diagnostic interpretation of the ECG data. Only the trained physician can provide such diagnosis. The cardiac data processed by the Premier 11 Holter is used by trained medical professionals to assist them to perform diagnosis on patients with various cardiac rhythm patterns.

The Premier 11 provides the standard Holter ECG processing features; such as individual ECG print-outs, Full Disclosure ECG print-outs, multi-channel morphology and ST analysis, heart rate analysis, manual markers for measuring the QRS width in both filtered and unfiltered modes, editing of arrhythmias, editing of ECG strips. editing of abnormal ECG events, selection of desired page prints for the Holter report, PageScanning of 100% of the 24-hour ECG, and storage of the Holter ECG file for future review of the data.

Here's a breakdown of the acceptance criteria and study information for the Premier 11 Holter, based on the provided text:

Acceptance Criteria and Device Performance

The provided document (a Special 510(k) Notification from 2006) doesn't explicitly state new, quantitative acceptance criteria for the Premier 11 Holter. Instead, it asserts substantial equivalence to existing predicate devices (K911615B Premier Holter system and K031466 IQmark Digital Holter). The primary acceptance criterion appears to be that the Premier 11 performs "essentially the same" and "function[s] in the same manner" as its predicates, particularly regarding the analysis algorithm and the analytical results. The key justification for substantial equivalence is that the core analysis algorithm remains unchanged from the K911615B Premier software, and the modifications are primarily in the operating system environment (DOS to Windows).

Therefore, the reported device performance is equivalent to the predicate devices, as the core analysis is identical.

Study Information

The document describes a verification and validation process rather than a traditional clinical study with a detailed test set of patient data.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of patient cases or recordings but referred to as "the same testing data bases."
   • Data Provenance: The data bases were used for verification and validation of the K911615B Premier Holter software from the mid-1990s and are now used for the Premier 11 software. This indicates retrospective usage of previously established internal testing data. No country of origin is specified, but given the submitter's location (Stateline, NV, USA), it's likely U.S.-centric or internal company data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The text focuses on the software's analytical output rather than external expert ground truth for specific diagnoses.

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

   • This information is not provided. The "ground truth" seems to be the expected analytical output from the established predicate algorithm.

4. 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 MRMC study was done. The device (Premier 11 Holter) is an analysis tool for recorded ECG data, which then supports a "trained physician" for diagnosis. It's not described as an AI-assisted diagnostic tool that directly improves human reader effectiveness in the way more modern AI/ML devices are. The "analysis algorithm" itself is the device.

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

   • Yes, in effect. The core of the evaluation is a comparison of the Premier 11 (algorithm only) against the predicate Premier (algorithm only) using the "same testing data bases" to confirm "the analysis results are the same." The software generates numerical reports and supports the physician, but its own performance as an algorithm is what's being verified. The device does not provide diagnostic interpretation; that is left to the physician.

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

   • The "ground truth" for the verification and validation appears to be the established and expected analytical results produced by the predicate K911615B Premier software when run on "the same input data." This is an internal, computational ground truth rather than clinical ground truth (e.g., from pathology or expert consensus on patient outcomes).

7. The sample size for the training set:

   • Not applicable / not provided. As this is a modification of an existing, already-cleared algorithm rather than a de novo AI/ML model being developed, there's no mention of a separate "training set" in the context of contemporary machine learning. The algorithm itself was developed and validated earlier.

8. How the ground truth for the training set was established:

   • Not applicable / not provided. See above. The document describes verification that the pre-existing algorithm's output remains unchanged despite operating system migration.

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The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The DMS 300-7 is indicated for use in a clinical setting, by qualified medical professionals only, for recording 3-channel ECG data of patients requiring ambulatory 24-hour monitoring. Holter ECG is appropriate for the indications below:
.Evaluation of adult patients with symptons suggesting arrhythmia
.Evaluation of adult patients with pacemakers
.Evaluation of patients with suspected abnormal heart rate changes
.Evaluation of patients with suspected abnormal QRS interval changes
.Evaluation of patient response to drug therapy treatment

The modified DMS 300-7 Holter ECG recorder is intended for use as a part of a Holter analysis system and is designed to be used with the DMS Premier Holter system. The DMS 300-7 provides three (3) channels of continuous ECG recorded over a 24-hour time period. The DMS 300-7 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient 3-channel ECG data that has been stored in the DMS 300-7. The cardiac data provided by the DMS 300-7 recorder and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.

The DMS 300-7 is a 3-channel ECG recorder that uses either a five (5) or seven (7) electrode ECG cable, as is the same with the predicate Model 300 ECG Recorder. The five (5) electrode ECG cable records a modified V1, V3, Lead II ECG recording. The seven (7) electrode ECG cable records three (3) bipolar leads, and can be used for an XYZ recording. A patient activated ECG Event button can be pressed by the patient to flag a symptomatic cardiac event ECG, as is the same with the predicate Model 300 ECG Recorder.

The DMS 300-7 uses a single AA alkaline battery as its power source, and stores acquired ECG data on a removable, non-volatile memory compact flash card. Stored ECG data is then downloaded to the hard disk drive of the Premier Holter system via a standard PCMCIA reader interface. The recorded data will remain in memory until it has been cleared by the clinician.

Here's a breakdown of the acceptance criteria and study information for the DMS 300-7 Holter ECG Recorder, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the DMS 300-7 Holter ECG Recorder as substantially equivalent (SE) to its predicate devices, primarily the DMS 300 ECG Recorder (K923664) and the Datrix DR512 Holter Recorder (K982975). The basis for this equivalence is that "testing of the device with the same input signals produces the same results in the processing of the data with the same Holter playback device."

The acceptance criteria are implicitly defined by the specifications of the predicate devices. The study performed aims to demonstrate that the DMS 300-7 meets these established specifications.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The document states: "The Final Test results of the predicate 300 ECG Recorder (K923664) and the modified submission device DMS 300-7, show that testing of the device with the same input signals produces the same results in the processing of the data with the same Holter playback device."

This indicates a functional equivalence test was performed rather than a clinical study with patients to evaluate diagnostic accuracy. The study focused on technical performance and data fidelity.

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as "test set" in terms of patient data. The study involved "the same input signals" but does not quantify how many unique signals or recordings were used.
   • Data Provenance: Not specified. It's an engineering or laboratory test using standardized input signals, not real-world patient data in this specific context.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts & Qualifications: Not applicable. The "ground truth" for this engineering test would be the known characteristics of the "same input signals" used to test both devices. This is a technical comparison, not a diagnostic accuracy study requiring expert human interpretation for ground truth.

3. Adjudication method:

   • Method: Not applicable. This was a direct comparison of output data from two devices given the same input, to verify identical processing. No subjective interpretation or adjudication by multiple individuals is mentioned.

4. 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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a Holter recorder, which acquires and stores data; it does not perform cardiac analysis itself. It is intended to be used with the DMS Premier Holter system for processing, which then provides data to trained medical personnel. The document focuses on the equivalence of the recorder's data acquisition and storage, not on the diagnostic performance of the overall system or human readers.

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

   • Standalone Study: The document states, "The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system." Therefore, a standalone performance study of an algorithm within the recorder itself was not conducted, as the recorder does not contain such an algorithm. The study was a comparison of the recorder's output given specific inputs.

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

   • Ground Truth: For the "testing of the device with the same input signals," the ground truth would be the known characteristics of these input signals themselves. This is a technical validation against a defined standard or reference waveform, not a clinical ground truth like pathology or expert consensus on patient data.

7. The sample size for the training set:

   • Training Set Size: Not applicable. This device is a data acquisition and storage device, not a machine learning or AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable, as there is no training set for this device.

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