(197 days)
The models 438-07 and 435-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. Active-fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.
The Intermedics Cardifix™ EZ Models 438-07 (bipolar) and 435-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for atrial or ventricular applications for long term cardiac pacing. The nominal length for the model 438-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal length for the model 435-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors. The models 438-07 and 435-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 365-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-89 ("J" stylet, limber), and model 365-90 ("J" stylet, firm). The model 435-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter. VS-1 unipolar lead to 6 mm unipolar pacer). The minimum introducer size recommended for the model 438-07 is 10 French. The minimum introducer size recommended for the model 435-07 is 7.5 French. The models 438-07 and 435-07 pacing leads are identical to the Intermedics models 438-05 (K922972, K954719) and 435-05 (K922972, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719) except that the dimensions of the cathode tip have been slightly modified to accommodate the active fixation corkscrew.
This document is a 510(k) summary for pacing leads, which are medical devices, not AI/ML software. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.
Here's an analysis of the provided text in relation to your request, indicating where information is present and where it is not applicable or unavailable:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the way one would describe for an AI/ML model (e.g., sensitivity, specificity, AUC thresholds). Instead, safety and effectiveness are established through:
- Design and Material Equivalence: The new models (438-07 and 435-07) are stated to be identical to predicate devices (438-05, 435-05, 430-07, 431-07) except for a minor modification to the cathode tip (IROX coating and slight dimension change to accommodate the corkscrew). This implies the acceptance criterion is equivalence to previously cleared devices.
- Biocompatibility Testing: The materials were evaluated in in vitro and in vivo tests (Hemolysis, MEM Elution Cytology, Ames Mutagenicity, USP Class V, Intramuscular Implantation, Maximization Sensitization, USP Pyrogen Test). The reported performance is that the materials "were not found to present any toxic liability under physiological conditions."
- Qualification Testing: "Complete qualification testing was performed on the predicate leads." For the new leads, specific testing was done on the modified tip to corkscrew joint "to verify the strength of this joint." The reported performance is "All of the test samples successfully completed the qualification testing."
- Clinical Experience of Predicate Devices: The "extremely low incidence of clinical complications" of the predicate devices (438-05, 435-05, 430-07, and 431-07) is cited as evidence of effective performance, and based on similarity, the new devices are "expected to perform with comparable efficacy."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design and Materials: Equivalence to predicate devices | New models are identical to predicate devices except for minor cathode tip modification (IROX coating and dimensions for corkscrew). |
| Biocompatibility: No toxic liability under physiological conditions | Materials "were not found to present any toxic liability under physiological conditions" based on various tests (in vitro/in vivo). |
| Qualification Testing: Successful completion of tests (especially for modified joint) | All test samples for the tip to corkscrew joint "successfully completed the qualification testing." Predicate leads also underwent full qualification testing. |
| Clinical Performance: Comparable efficacy to predicate devices | Predicate devices showed "extremely low incidence of clinical complications," and new devices are "expected to perform with comparable efficacy" due to similarity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not explicitly stated. For biocompatibility, it refers to "test systems" and "test data." For qualification testing, it mentions "All of the test samples." No specific numbers or human patient count are provided for these tests.
- Data provenance: Not specified. The biocompatibility and qualification tests are laboratory/bench tests, not clinical studies with human data tied to specific locations or retrospective/prospective designations. The "clinical experience" cited is from commercially available predicate devices, implying real-world data but without details on its origin or nature (e.g., registries, individual reports).
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. This pertains to establishing ground truth for AI/ML models based on expert review. The studies described are engineering qualification tests and biocompatibility tests, not studies requiring expert review for ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for studies where multiple readers or experts assess cases. The studies here are focused on device engineering and material properties.
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 a medical device approval, not an AI/ML software. No MRMC study was performed, and there is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device approval, not an AI/ML software. No algorithm is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground truth for Biocompatibility: Laboratory test results based on established international standards (e.g., ISO for hemolysis, USP for pyrogen).
- Ground truth for Qualification Testing: Engineering specifications and successful completion of designed tests (e.g., strength of a joint).
- Ground truth for "Clinical Experience": Implied real-world performance data (low incidence of complications) from existing, commercially available predicate devices. This aligns somewhat with "outcomes data," but is presented as a general summation rather than a specific study.
8. The sample size for the training set
- Not applicable. There is no AI/ML model, and thus no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.
In summary: The provided document is a 510(k) submission for conventional medical devices (pacing leads), relying on equivalence to predicate devices and results from engineering and biocompatibility tests. It does not involve AI/ML technology, and therefore, most of your questions related to AI/ML study design and performance metrics are not applicable to this specific document.
§ 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.