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BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.

The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.

Elox (EX xx-BP) is a straight, bipolar endocardial pacing lead utilizing an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal Iridium coating. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The lead contains two conductors composed of quadrifilar MP35N wire in coaxial configurations and is insulated with silicone tubing. A 3.2 mm IS-1 bipolar connector attaches the lead to the pulse generator. The Elox lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

The provided text is a 510(k) summary for the Elox Active Fixation Endocardial Lead. It describes the device, its indications for use, and lists predicate devices. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or clinical study details (like MRMC studies) that would be needed to answer your questions.

Therefore, I cannot generate the requested table and information based on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed report of performance studies.

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Synox leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class I definition of the ACC/AHA Task Force Report, entitled "Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices" (JACC, Vol. 18, No. 1, July 1991:1 - 13).

Synox xx/15-BP leads are bipolar, passive fixation endocardial leads that feature three for fixation in the heart's trabeculae. The tip electrode is made of a titanium base material with a surface treatment of fractal iridium and a surface area of 1.3 mm². The ring electrode is made of a platinum/iridium base material with a surface treatment of fractal iridium and a surface area of 34 mm². The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with sillcone rubber tubing. All Synox leads utilize a 3.2 mm IS-1 connector.

The provided 510(k) notification for the BIOTRONIK Synox Passive Fixation Endocardial Lead describes a medical device, not an AI/ML powered device. As such, it does not involve the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a regulatory pathway where the new device is compared to a legally marketed device (the predicate) in terms of intended use, technological characteristics, and safety and effectiveness.

Therefore, many of the requested elements regarding sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable.

Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" in the context of substantial equivalence:

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

In the context of a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met if the new device is shown to be as safe and effective as the predicate device. The document states the modification is a reduction in electrode spacing and a change in silicone insulation. The performance is implied to be equivalent to the predicate device because of the minor nature of the changes and the direct comparison to existing approved designs.

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

Not applicable. This is not an AI/ML performance study. The 510(k) submission relies on demonstrating substantial equivalence to a predicate device and engineering design changes. No specific "test set" of patient data or clinical study data is detailed in the provided summary for performance evaluation.

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. No "ground truth" establishment by experts in the context of AI/ML validation is described. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

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

Not applicable. There is no described "test set" 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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware medical device (pacemaker lead), not an algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" equivalent in a 510(k) is the established safety and effectiveness of the predicate device(s). The FDA's clearance signifies that the new device is substantially equivalent to these legally marketed predicates.

8. The sample size for the training set

Not applicable. No AI/ML model training is involved.

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

Not applicable. No AI/ML model training is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The study described is a regulatory submission based on substantial equivalence. The manufacturer (BIOTRONIK, Inc.) demonstrated that the Synox 53/15-BP and 60/15-BP leads are substantially equivalent to their own currently marketed and FDA-cleared predicate devices (Synox leads approved under K980869).

The "proof" for substantial equivalence was established by:

• Identifying Predicate Devices: BIOTRONIK's Synox passive fixation endocardial leads (straight and "J" configurations) cleared under K980869.
• Comparing Intended Use: Showing the new leads share the identical intended use with the predicate devices.
• Comparing Technological Characteristics: Highlighting that the new device is a modified version of existing Synox leads. The primary modification is a reduction in the distance between ring and tip electrodes from 31 mm to 15 mm and a corresponding change in the silicone insulation. Crucially, the 15 mm spacing is identical to that of other "J" shaped Synox leads already cleared as predicates. Other characteristics (materials, surface treatment, conductor, connector) are stated to be the same as the predicate.
• Demonstrating No New Questions of Safety/Effectiveness: By showing the changes are minor and by comparing them to already cleared designs (specifically, the 15mm spacing already exists in predicate "J" leads), the submission implicitly argued that no new safety or effectiveness concerns were raised that would differentiate it from the predicate.

The FDA's clearance letter ("We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...") serves as the official "proof" that the device meets the regulatory acceptance criteria for market entry via the 510(k) pathway.

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