(85 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Identical to predicate device. | Confirmed. Indications for Use are consistent with predicate. |
| Technological Characteristics: | |
| - Bipolar, passive fixation endocardial lead. | Confirmed. |
| - Three tines for fixation. | Confirmed. |
| - Tip electrode material and surface area. | Confirmed (titanium base, fractal iridium, 1.3 mm²). |
| - Ring electrode material and surface area. | Confirmed (platinum/iridium base, fractal iridium, 34 mm²). |
| - Lead conductor type and insulation. | Confirmed (quadrifilar MP35N wire, silicone rubber). |
| - IS-1 connector. | Confirmed (3.2 mm IS-1). |
| - Electrode spacing (New vs. Predicate) | New: 15 mm. Predicate: 31 mm (straight), 15 mm ("J" shaped). The new 15mm spacing is deemed identical to the "J" shaped Synox leads, which are also predicates. |
| - Silicone insulation design (New vs. Predicate) | Modified from tapered to consistent thickness due to reduced spacing. This is a design change, but not presented as impacting safety/effectiveness. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device. | Implied by the FDA's clearance letter ("We have determined the device is substantially equivalent..."). |
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.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.