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SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or ﺴ
• other compatible cassette tape recorder. -
  In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or -
• other compatible cassette tape recorder. -

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727) -

HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:

• Patient symptoms such as syncope, dizziness or palpitations. .
• Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
• Function of an implanted pacemaker or defibrillator. .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).

SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.

The provided document is a 510(k) summary for ELA Medical's Holter ECG analysis software and related tools (SyneScope™, EasyScope™, SyneCom™, and HolterReader). It focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a study to prove performance against those criteria.

Therefore, the information requested in your prompt regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, and multi-reader multi-case studies is not present in this document.

The document does mention "functional testing" and "software verification and validation testing," but it defers the details to attachments (e.g., Attachment 10.6 for software verification and validation, Attachment 10.9 for safety and performance tests according to AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards, and Attachment 10.4 for field testing). Without these attachments, a complete answer to your request cannot be provided.

Based only on the provided text, here's what can be extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document mentions adherence to standards (AAMI/ANSI EC38:1998 & IEC 60601-2-47) and functional testing, but it does not present a table of specific quantitative acceptance criteria or device performance metrics against those criteria.

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

The document refers to "functional testing," "software verification and validation testing," and "field testing" but does not specify the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. 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.

4. Adjudication method for the test set

This information is not provided in the document.

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

The document describes software for Holter ECG analysis and reporting, but it does not mention any MRMC comparative effectiveness study evaluating human reader improvement with or without AI assistance. This type of study is typically associated with AI-driven diagnostic aids. The device's description (Holter ECG analysis software) suggests it's an analysis tool, not necessarily an AI-assisted diagnostic system in the modern sense.

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

While the software performs automated analysis, the document emphasizes its use "under the supervision of licensed and trained practitioners." It does not present a standalone performance evaluation of the algorithm explicitly separate from human oversight. The "functional testing" and "software verification and validation" (references to attachments 10.6 and 10.9) likely cover the algorithm's performance, but the details are not included.

7. The type of ground truth used

The document refers to "functional testing" and "field validation," but it does not explicitly state the type of ground truth data used (e.g., expert consensus, pathology, outcomes data, etc.) for these evaluations. For Holter analysis, ground truth would typically come from expert cardiologist review of ECG recordings.

8. The sample size for the training set

The document does not mention a training set as this is a 510(k) for software functionality and equivalence, not explicitly for a machine learning or AI algorithm in the context of a "training set."

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

As no training set is mentioned, this information is not provided.

Summary of Studies Mentioned (without details):

The document states:

• SyneScope™, EasyScope™, SyneCom™ and HolterReader safety and performance testing: "Safety and performance tests according to the AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards." (Details in Attachment 10.9)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader software verification and validation testing: "Module and functional testing for SyneScope™, EasyScope™, SyneCom™ and HolterReader software applications." (Details in Attachment 10.6)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader field testing: "Field validation protocol and evaluation form completion." (Details in Attachment 10.4)

In conclusion, while the document confirms that various tests were performed to demonstrate that the device performs in a safe and effective manner and complies with relevant standards, it does not provide the specific details of acceptance criteria, quantitative performance, sample sizes, ground truth establishment, or human-in-the-loop study results you requested. These details would likely be found in the referenced attachments.

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• Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period.
• High-resolution recording of surface ECG data.
• Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.

The SpiderView ™ Holter recorder is designed to acquire and store, in a digital format, multiple channels of surface ECG data (from 2 to 9 Leads) for a period up to 96 hours. The device stores the acquired ECG data on a removable flash memory card. ECG signals are converted at a rate of 200 to 1000 samples per second, which allows accurate reproduction of the ECG signal to perform signal averaging ECG analysis. The Holter scanner software (sold separately) reads these data and prints them out in tabular or graphical form. This recorder does not perform any analysis on the ECG data. SpiderView™ is supplied in a case containing a 16, 32, or 64 MB flash-memory card, one 1.5 V AA battery, a carrying case, a strap, five patient cables, a set of ECG electrodes, and a user's manual.

The manufacturer, ELA Medical, Inc., submitted a 510(k) premarket notification for the SpiderView Holter ECG recorder. This device is intended to acquire and store multi-channel surface ECG data for up to 96 hours. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence by comparing the SpiderView Holter ECG recorder's technological characteristics to those of predicate devices. Formal acceptance criteria with specific performance thresholds (e.g., accuracy percentages) are not explicitly stated in the provided text. Instead, the "performance" is implicitly demonstrated through the functional capabilities and specifications that are comparable to or exceed those of the predicate devices.

2. Sample Size and Data Provenance for Test Set

The provided summary does not detail a "test set" in the context of clinical performance data. The studies mentioned are:

• In-vitro functional testing: This refers to the testing performed in a controlled laboratory environment, not on human subjects.
• Safety testing: This includes environmental, safety, and EMC tests according to specified standards.
• Software validation and verification testing: Module and functional testing for software applications.

Therefore, there is no sample size or data provenance for a clinical test set involving patient data mentioned for the SpiderView Holter ECG recorder. The device is a data acquisition device, and its safety and performance are primarily assessed through engineering and functional testing against standards, and comparison of its technical specifications to those of legally marketed predicate devices.

3. Number of Experts and Qualifications for Ground Truth of Test Set

As there is no clinical "test set" or human-in-the-loop performance evaluation described, there are no experts mentioned as establishing ground truth for such a set. The "ground truth" for the functional and safety testing would be adherence to engineering specifications and regulatory standards.

4. Adjudication method for the Test Set

Given the nature of the studies described (in-vitro functional, safety, and software validation), an adjudication method (like 2+1, 3+1) is not applicable or mentioned. Adjudication typically applies to evaluating interpretations of clinical data by multiple human readers.

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

No MRMC comparative effectiveness study is mentioned. This type of study would typically assess how human readers perform with and without an AI-assisted device in interpreting clinical cases. Since the SpiderView device is solely a data recorder and does not perform any analysis or interpretation, an MRMC study is not relevant or described in the submission.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No standalone performance study is explicitly described as the device itself does not contain an "algorithm" for analysis or interpretation of ECG data. Its function is to record high-fidelity ECG signals. The statement "This recorder does not perform any analysis on the ECG data" directly indicates that it is not an AI-enabled interpretative device. The software validation mentioned is for the device's operational software, not an analytical algorithm.

7. Type of Ground Truth Used

For the in-vitro functional, safety, and software validation testing, the ground truth would be based on:

• Engineering specifications: The device is expected to perform according to its design specifications.
• Regulatory standards: The safety and EMC testing confirms compliance with harmonized standards (IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998).
• Predicate device characteristics: Substantial equivalence is argued based on the SpiderView's technical characteristics being comparable to, or improved upon, the predicate devices.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's premarket notification.

8. Sample Size for the Training Set

Since the SpiderView is a data recording device and not an analytical or AI-driven system that would require a "training set" for an algorithm, there is no training set sample size mentioned.

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

As there is no training set for an analytical algorithm, the concept of establishing ground truth for a training set is not applicable to this submission.

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ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.

ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle.

ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.

Stela™ Model BT45/46 and UT46 straight tined pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the ventricle.

Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium.

Stela™ Model UT 46 and UJ45 are silicone rubber, unipolar transvenous leads, similar in design and construction to bipolar models BT45/46 and BJ44/45, respectively.

The following silicone rubber material change was performed on Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads:

Affected components: Straight extruded tubing components (inner and outer lead isolation)
Current material: Dow Corning HP 77020 SP50
New material: Applied Silicone* HCRA HP 50E (part number 40094)

This is not an AI/ML device, therefore, the traditional acceptance criteria and study design elements requested in the prompt (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are not applicable.

The submission K993448 is a Special 510(k) for a device modification (silicone tubing change) to existing Stela™ pacing leads. The focus is on demonstrating that the modified device remains safe and effective despite the material change, and is substantially equivalent to the previously cleared predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML performance. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device's performance is comparable to or unaffected by the material change, based on established industry standards and internal testing.

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

• Sample Size:
  • For biocompatibility (implantation): 4 sheep (animals) for a 3-month endocardial implantation.
  • For in-vitro functional testing: Not specified in the summary. This would typically involve a certain number of manufactured lead samples (e.g., N=10, N=30) per test, but the exact count isn't provided in the summary document.
• Data Provenance:
  • The animal study (sheep) is likely prospective and conducted specifically for this regulatory submission. Country of origin for the animal study is not specified.
  • The in-vitro functional tests are laboratory-based and conducted on newly manufactured leads with the new material.

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

• This is not an AI/ML study; therefore, the concept of "experts establishing ground truth for the test set" in that context is not applicable.
• For the animal study histology and tissue analysis, trained veterinary pathologists or researchers would evaluate the results. Their number and specific qualifications are not detailed in the summary.

4. Adjudication method for the test set

• Not applicable as this is not an AI/ML study requiring adjudication of expert interpretations. The evaluation of functional test results and biocompatibility study outcomes would follow standard laboratory and histological assessment protocols, likely by a single qualified individual or a lab team.

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 is not an AI/ML device; therefore, an MRMC study is not relevant.

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

• No. This is not an AI/ML device; therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used

• The "ground truth" here pertains to the objective performance characteristics of the physical device and its biological interaction.
  • Functional Testing: The "ground truth" is derived from direct measurements and observations during standard in-vitro engineering tests (e.g., measuring tensile strength, electrical resistance, leakage, fatigue cycles).
  • Biocompatibility: The "ground truth" is established through histological analysis (microscopic examination of tissue response) and blood tests (hemolysis, coagulation time) following internationally recognized standards (ISO 10993). This is direct biological and pathological evidence.

8. The sample size for the training set

• Not applicable. This is a physical device modification, not an AI/ML model that requires a training set.

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

• Not applicable. No training set for an AI/ML model.

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• Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period.
• High-resolution recording of surface ECG data.
• Analysis of recorded Holter ECG data.

Syneflash™ is a light-weight digital ambulatory electrocardiogram (ECG) recorder (Holter monitor) equipped with a graphic LCD screen, and using a flash-memory card for data storage. It allows 24-hour ambulatory ECG recording and high-resolution recording, using 2 or 3 channels. Syneflash™ is supplied in a case containing a 10-, 20- or 40-MB flash-memory card, two 1.5-V AA batteries, a carrying case, a strap, a five-lead (or seven-lead) patient cable and a user's manual. Syneview™ is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained with Syneflash™. Syneview™ is a Microsoft Windows95/98-based application run on an IBM-compatible personal computer equipped with a flash-card reader.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions validation against the AHA (American Heart Association), MIT (Massachusetts Institute of Technology), ST (European database on ST segment), and NST (Noise Stress Test) databases. However, it does not specify the sample size (number of cases/recordings) used from each of these databases for the test set.

The provenance of these databases is given by their names:

• AHA (American Heart Association): Implies data from the United States.
• MIT (Massachusetts Institute of Technology): Implies data from the United States.
• ST (European database on ST segment): Implies data from Europe.
• NST (Noise Stress Test): This likely refers to a synthetic or specifically prepared dataset designed to test noise robustness, rather than a collection of clinical patient data.

The document does not explicitly state whether the data from these databases was retrospective or prospective, but publicly available, established databases like AHA and MIT are typically retrospective collections of previously recorded data.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth of the databases used (AHA, MIT, ST, NST). For established public databases, the ground truth is typically pre-annotated by experts or derived from established clinical criteria.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used for establishing the ground truth in the test sets. For public databases, the annotations are usually a result of a consensus process among previous experts or follow specific guidelines.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in this submission. The testing described focuses on the standalone performance of the device against established databases, not on human reader improvement with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The "Syneview™ database testing" directly assessed the performance of the Syneview™ analysis software (the algorithm) against the AHA, MIT, ST, and NST databases. This is a measure of the algorithm's performance without a human in the loop during the analysis phase.

7. The Type of Ground Truth Used:

The ground truth used was based on expert consensus/established annotations from the reference databases:

• AHA (American Heart Association) database: Contains expert-annotated ECG recordings, often used for arrhythmia detection algorithm validation.
• MIT (Massachusetts Institute of Technology) database: Specifically, the MIT-BIH Arrhythmia Database, which is widely used and contains expert-verified annotations for various cardiac arrhythmias.
• ST (European database on ST segment): Likely contains expert-verified annotations related to ST-segment changes relevant to ischemic events.
• NST (Noise Stress Test): This database would have a predefined "ground truth" concerning the presence and characteristics of noise, against which the system's robustness is evaluated.

8. The Sample Size for the Training Set:

The document does not specify the sample size used for the training set. It only describes the testing performed on the device.

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

The document does not provide information on how the ground truth for the training set was established. The focus of this submission is on the validation and verification of the device, not the details of its development or training data.

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ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. J-shaped leads are intended for permanent pacing and sensing of the atrium.

The Stela™ Model UJ45 is a silicone rubber, tined, J-shaped, unipolar transvenous lead that provides a permanent electrical pathway between a pacemaker and the atrium. It is similar in design and construction to other such leads in commercial distribution.

The provided document is a 510(k) submission for a medical device (Stela™ Model UJ45 Pacing Lead) and its associated FDA clearance letter from 1998. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for safety and effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/diagnostic devices. Specifically, it does not include:

• A table of acceptance criteria and reported device performance metrics in the way you've requested (e.g., sensitivity, specificity, AUROC).
• Details about a test set (sample size, data provenance), ground truth establishment, or expert adjudication for performance evaluation.
• Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details.

Instead, the document states:

• "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." (Section 2.1.7)
• The device's safety and effectiveness are supported by its substantial equivalence to predicate devices (ELA Medical Focus® Model J43F and Stela™ Model BJ45), which have a history of successful use.
• The primary "studies" mentioned are in-vitro functional testing to ensure the new model met basic engineering specifications, consistent with existing lead products.

Here's a breakdown of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly states that these tests were "performed" and contributed to the conclusion that the device would "perform in a safe and effective manner," suggesting that it met internal specifications for these functional tests. Specific quantitative performance values or defined acceptance thresholds are not provided in this public summary.

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

• No specific "test set" in the diagnostic/AI sense was used. The evaluation relied on in-vitro functional testing of the device itself and comparison to predicate devices, not on a dataset of clinical cases for diagnostic performance.
• The in-vitro tests were conducted on the Stela™ Model UJ45 leads. The sample size for these specific in-vitro tests is not specified in the document.
• Data provenance: Not applicable in the context of clinical data for performance evaluation. The data is from in-vitro engineering tests of the device itself.

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

• This is not applicable as there was no clinical "test set" requiring ground truth established by experts for performance evaluation. The functional tests likely had engineering specifications as their "ground truth" and were evaluated by engineers/technicians.

4. Adjudication method for the test set

• This is not applicable as there was no clinical "test set" requiring expert adjudication for performance evaluation.

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 such study was performed. This device is a pacing lead, not an AI-assisted diagnostic tool or an imaging analysis system. The concept of human readers improving with AI assistance is not relevant to this submission.

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

• Not applicable. This is a hardware medical device (a pacing lead), not an algorithm or AI system.

7. The type of ground truth used

• For the in-vitro functional testing, the "ground truth" would be established engineering specifications and performance standards for each test (e.g., a certain electrical resistance range, a minimum tensile strength).

8. The sample size for the training set

• Not applicable. This device is a pacing lead, not an AI system that requires a "training set."

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

• Not applicable.

Summary Rationale from the Document:

The FDA 510(k) clearance for the Stela™ Model UJ45 Pacing Lead was based on demonstrating "substantial equivalence" to legally marketed predicate devices, not on new clinical trials or performance studies as would be required for novel diagnostic algorithms. The manufacturer explicitly states: "No clinical study was required to demonstrate safety and effectiveness since the Stela™ Model UJ45 presents no new feature." The in-vitro functional tests were performed to confirm that the new model met established engineering standards consistent with its predicate devices.

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• AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle),
• Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers. The electronic circuit and battery are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions are assured by a hybrid circuit with passive components and integrated circuits (microprocessor and custom circuit). The programmer system consists of a programming head, programmer software, and an IBM-compatible PC.

The provided text describes the safety and effectiveness information for the ELA Medical Opus S Model 4121 and 4124 pacemakers, which are single-chamber SSI pacemakers. The document details the device description, comparison to predicate devices, potential adverse effects, and a summary of studies conducted to ensure its performance.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in the way one might expect for a quantitative clinical study. Instead, it describes various "Tests" conducted under different "Test groups." The general statement, "All test results demonstrated that the established pass / fail criterion was met in all cases," indicates that the devices successfully passed the acceptance criteria for each test.

Below is a table summarizing the test groups and the types of tests performed. The "Acceptance Criteria" for these are implied to be success in passing the specific validation or performance standards relevant to each test type (e.g., proper mechanical function, electrical isolation, sterility). The "Reported Device Performance" is the overarching statement that all criteria were met.

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

The document comprehensively lists various in-vitro functional testing performed on the Opus S Model 4121 and 4124 pacemakers. However, it does not specify the sample sizes used for these in-vitro tests (e.g., how many units were subjected to thermal shock, how many connectors were tested). It also does not mention the country of origin of the data or whether the tests were prospective or retrospective. Given that these are in-vitro functional tests, they would inherently be prospective.

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)

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving human interpretation or clinical endpoints (e.g., image analysis, disease diagnosis). The studies described here are primarily in-vitro functional and environmental tests for a medical device (pacemaker). Such tests rely on engineering specifications, standardized protocols, and instrument measurements rather than expert human interpretation for "ground truth." Therefore, this information is not applicable to the described verification and validation activities.

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

Similar to point 3, adjudication methods (like 2+1 or 3+1 consensus) are typically used in studies where there's subjectivity in determining ground truth (e.g., reviewing medical images). For the in-vitro functional and environmental tests described, the 'truth' is determined by whether the device's performance meets pre-defined engineering specifications and standards. There is no mention of an adjudication method as it would not be relevant for these types of objective functional tests.

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

The document describes the verification and validation of a pacemaker, which is an implantable electronic device, not an AI-powered diagnostic tool requiring human reader assistance. Therefore, no MRMC comparative effectiveness study was performed or is applicable to this device. This information is irrelevant in the context of pacemaker approval.

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

This question is also generally related to AI algorithms. While the pacemaker itself functions in a "standalone" manner within the patient, and its software (implant and programmer) underwent validation, the concept of "standalone performance" in the context of an "algorithm only without human-in-the-loop performance" typical for AI diagnostics does not directly apply here. The device's performance is its intrinsic function, which was verified through extensive testing as detailed. There isn't an "algorithm" in the sense of a predictive model being assessed for its diagnostic accuracy.

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

For the in-vitro functional and environmental tests conducted on the pacemaker, the "ground truth" is established by engineering specifications, international standards (e.g., for EMI, ESD, vibration), and predefined pass/fail criteria derived from the device's design requirements. For example, for "Electrical Isolation," the ground truth is a measurement confirming that certain leakage currents or resistance levels are not exceeded. For "Sterilization Process Validation," the ground truth is evidence of sterility (e.g., via biological indicators) after the process. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests. Biocompatibility was handled by relying on predicate device history, which implicitly references previous outcomes data and regulatory acceptance.

8. The sample size for the training set

The document describes the verification and validation of manufactured devices, not the development of an AI model that requires a "training set." Therefore, this information is not applicable. The "training" for such a device effectively happens during its design and manufacturing process, using engineering principles and established requirements.

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

As there is no training set in the context of AI/machine learning for this device, the question of how its ground truth was established is not applicable.

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ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.

Stela™ BJ44 and BJ45 models are silicone rubber, tined, J-shaped, bipolar transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. They are similar in design and construction to other such leads in commercial distribution.

The provided text describes the Stela™ Models BJ44 and BJ45 pacing leads. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• In-vitro functional testing, sterilization, and packaging validation: The text states "All test results demonstrated that the established pass / fail criterion was met in all cases." However, it does not specify the sample size for these in-vitro tests.
• Clinical study: Described as a "limited clinical study." The exact sample size is not provided, only that it involved the Model BJ45 lead.
• Data Provenance:
  • In-vitro tests: Likely conducted in a lab environment by the manufacturer (ELA Medical).
  • Clinical study: The text indicates the device was "recently introduced into commercial distribution outside the U.S." and that "No unanticipated adverse device effects have been reported for these leads" from this OUS experience. The limited clinical study mentioned is likely related to this OUS experience or a precursor to it. It is a prospective study for the clinical data from the "limited clinical study."

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

• Not Applicable. The described studies are primarily in-vitro engineering tests and a limited clinical study evaluating device performance, not diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method:

• Not Applicable. See point 3.

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

• No. An MRMC study was not described. This device is a medical lead, not an imaging or diagnostic AI tool that would typically undergo an MRMC study.

6. Standalone Performance:

• Partially. The in-vitro functional testing, sterilization, and packaging validation can be considered standalone performance assessments of the device itself (algorithm only is not applicable here as it's a hardware device).
• The "limited clinical study" also assesses the device's performance in patients in a standalone manner (without another human-in-the-loop comparison).

7. Type of Ground Truth Used:

• In-vitro functional testing: The ground truth is based on engineering specifications and established pass/fail criteria for physical and electrical properties.
• Clinical study: The ground truth for pacing and sensing characteristics would be derived from physiological measurements and clinical observations in patients. The absence of complications serves as a negative ground truth.

8. Sample Size for the Training Set:

• Not Applicable. The description does not involve a "training set" in the context of machine learning or AI. This is a hardware device.

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

• Not Applicable. See point 8.

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