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The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators.

The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used.

Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:

• Symptomatic paroxysmal or permanent second or third-degree AV block .
• Symptomatic bilateral bundle branch block .
• Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders
• . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
• Vasovagal syndromes or hypersensitive carotid sinus syndromes .

BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators.

Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies.

The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U.

There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.

The provided text does not contain detailed information regarding acceptance criteria, device performance metrics, or study designs typically used to prove that a device meets specific acceptance criteria in the context of device performance. This document is a 510(k) submission summary for the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's Pikos family of pulse generators, focusing on regulatory clearance based on substantial equivalence.

The core of the submission is that the NIPS feature is being "unlocked" from existing, previously FDA-approved pulse generators (Pikos family) and utilizes existing hardware and software drivers. The clearance is based on the premise that there are no hardware changes to the pulse generators or programmer system, and the primary functions remain the same. Therefore, the regulatory decision appears to be based on the substantial equivalence to the previously cleared devices rather than a new performance study with specific acceptance criteria as one might find for a novel device or feature requiring extensive clinical validation.

Without direct information from the text, I cannot complete the requested tables and descriptions. Many of the requested fields (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth establishment, training set details) are relevant to studies demonstrating new device efficacy or accuracy, which does not appear to be the focus of this 510(k) submission.

However, based on the information provided, here's what can be inferred or stated about the "acceptance criteria" and "study" in a regulatory context:

Implied Acceptance Criteria (Regulatory):

The implied acceptance criteria for this 510(k) submission relate to the device's safety and effectiveness compared to a predicate device, as per FDA's substantial equivalence pathway.

• Safety: The NIPS feature, when unlocked, does not introduce new safety risks compared to the predicate devices. This is supported by the statement that "There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature" and that the "primary functions... remain the same."
• Effectiveness (Functional Equivalence): The NIPS feature performs its intended function (high rate pacing and EP studies) in a manner equivalent to how it would perform on previously approved devices or off-label use, or devices cleared outside the US. The fact that it's an "unlocked" feature using existing software drivers suggests its fundamental functionality is already established within the existing hardware.
• No New Indications/Contraindications: The indications/contraindications for use of the PIKOS products with the NIPS feature remain "identical to those for all single chamber (AAI or VVI) pulse generators." This implies no new therapeutic claims are being made that would require novel performance data.

The "Study" (Regulatory Review Process):

The "study" or review that proves the device meets these implied acceptance criteria is the FDA 510(k) Pre-market Notification Review Process.

This process involves:

• Documentation Review: BIOTRONIK submitted documentation (the 510(k) itself) outlining the device description, its intended use, technological characteristics, and comparison to predicate devices.
• Predicate Device Comparison: The core of the "proof" is the argument of substantial equivalence to previously legally marketed predicate devices. The submission highlights that the Pikos family pulse generators were "FDA approved for use with P950037/S8, dated 08-24-99)" and that the NIPS feature is generated "entirely through the existing pulse generator and lead system."
• Risk Assessment (Implied): The FDA implicitly assesses if unblocking this feature introduces new risks or changes the fundamental operating principles in a way that would necessitate a new class of controls or different regulatory pathway. The statement "There are no hardware changes... The primary functions... remain the same" directly addresses this.
• Labeling Review: Ensuring the indications for use align with the predicate device and the safety profile.

Given the nature of the document, the following table and descriptions are based on the regulatory context of substantial equivalence, not a typical performance study for accuracy or diagnostic capability.

1. Table of Acceptance Criteria and the Reported Device Performance

Additional Requested Information (where applicable from the text or inferred from the 510(k) context):

2. Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. This is a regulatory clearance for a software unlock feature on existing hardware, not a performance study requiring a test set of patient data. The "acceptance" is based on the argument of substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a traditional sense for a performance study. Regulatory review team at FDA serves as the "technical experts" assessing the submission.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication of results.
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 is not an AI-assisted diagnostic device, nor a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. The NIPS feature is an integrated function of a pacemaker controlled by a programmer with human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study. The "truth" for this submission is regulatory (i.e., substantial equivalence to predicate devices and established safety/efficacy of the base pacemakers).
8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set. The functionality is based on pre-existing, already developed and tested software drivers within an established device.
9. How the ground truth for the training set was established: Not applicable.

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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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The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:

• · Sinus node arrest or bradycardia with or without AV conduction disorder.
• · Intermittent or complete AV conduction block.
• · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
• · Atrial fibrillation and ventricular bradyarrhythmia.

The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.

This 510(k) submission (K945627) for the Pikos LP 01/LP B01 Implantable Pacemaker Pulse Generators focuses on demonstrating substantial equivalence to a predicate device (K914109/A, Pikos 01 and Pikos H01) rather than establishing new acceptance criteria through a clinical study. Therefore, most of the requested information regarding a study proving acceptance criteria will not be present.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define a table of new acceptance criteria and corresponding performance metrics from a distinct study for this device. Instead, it relies on demonstrating that the new device performs equivalently to a predicate device (Pikos 01/E01 models) based on pre-established performance of that predicate.

The qualification testing mentioned is primarily for design verification and validation of components and modifications, not for proving clinical performance against new acceptance criteria.

• Self-Sealing Header: "qualification reports describing the testing conducted for validation... included vibration, shock, temperature and transport tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization... was validated."
• Hybrid Circuit Modifications: "qualified with complete electrical and mechanical testing." (Implies meeting internal design specifications and performance standards). |
  | Safety and Effectiveness: | "The product labeling includes instructions for use adequate to assure safe and effective operation of the device." (Relies on the established safety and effectiveness of the predicate device and verification of modifications). |

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

No specific "test set" in the context of clinical data for proving new acceptance criteria is described. The "qualification testing" refers to engineering and bench testing.

• Sample Size: Not applicable in the context of a clinical test set from human subjects for this submission. The "sample" likely refers to components or finished devices subjected to various engineering tests (e.g., a certain number of self-sealing headers tested for leakage). These numbers are not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The qualification testing data would be generated in-house by BIOTRONIK GmbH & Co.

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

Not applicable. This submission is for a medical device that relies on engineering qualification and demonstrated equivalence, not a diagnostic algorithm requiring expert-established ground truth from a test set of human data.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 is not an AI-assisted diagnostic device, and no MRMC study or AI components are mentioned.

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

Not applicable for the reasons stated above.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the qualification testing of components and modifications (e.g., self-sealing header, hybrid circuits), the "ground truth" would be engineering specifications, international standards (like IS-1 mentioned for the header), and internal design requirements.

For the substantial equivalence claim, the "ground truth" is effectively the established safety and effectiveness profile and performance characteristics of the predicate device (Pikos 01/E01).

8. The Sample Size for the Training Set

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

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

Not applicable.

In summary: This 510(k) submission is for an implantable pacemaker pulse generator that relies on demonstrating substantial equivalence to an already approved predicate device. The "qualification testing" described is for verifying the design and manufacturing of the new device and any modifications, ensuring it meets engineering standards and is comparable to the predicate. It does not involve a clinical study with human subjects designed to establish new performance acceptance criteria for a novel device.

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