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The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.

The Medtronic model 5058 transvenous screw-in pacing lead has a helical tip electrode made of platinum alloy that can be actively fixed in the endocardium. The helix can be extended or retracted by rotating the lead connector pin with a fixation tool. This lead also has a second. larger electrode proximal to the tip electrode and an IS-1 Bipolar connector with one terminal pin. It features MP35N nickel-alloy coil conductors and silicone rubber insulation.

This document describes the Medtronic Model 5058 transvenous screw-in pacing lead, focusing on its design, intended use, and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices. The information provided is a 510(k) summary, which typically outlines the safety and effectiveness of a new device compared to previously cleared devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the Model 5058 lead. Instead, it broadly states that the testing "demonstrate[s] that the model 5058 will perform to Medtronic specifications" and that it is "considered substantially equivalent" to predicate devices. This indicates that the acceptance criteria are likely derived from the performance of the predicate devices and internal Medtronic specifications for mechanical, electrical, and biological compatibility.

However, the types of tests performed imply the areas where performance was assessed. We can infer the categories of acceptance criteria from the tests:

• Connector integrity (e.g., secure mating, no disconnections).
• Tip pressure resistance (e.g., withstands implantation forces).
• Leak integrity (e.g., no fluid ingress/egress).
• Joint and composite pull strength (e.g., resistance to detachment).
• Composite torsional strength (e.g., resistance to twisting).
• Anchoring sleeve suture retention (e.g., secure attachment).
• Flexibility/durability (e.g., withstands repeated bending).
• Stylet insertion/withdrawal (e.g., smooth passage, no damage). | "All of the testing performed on the model 5058 lead... demonstrate that the model 5058 will perform to Medtronic specifications." |
  | Electrical Performance | - Electrical resistance within specified limits.
• IS-1 offset block/AC impedance within specified limits (ensuring proper signal transmission and compatibility with pulse generators). | "All of the testing performed on the model 5058 lead... demonstrate that the model 5058 will perform to Medtronic specifications." |
  | Environmental Stability | - Withstands EtO sterilization process without degradation.
• Withstands thermal shock without degradation. | "All of the testing performed on the model 5058 lead... demonstrate that the model 5058 will perform to Medtronic specifications." |
  | Biocompatibility | - Material biocompatibility (e.g., non-toxic, non-irritating, non-allergenic).
• Biostability of insulation (e.g., resists degradation in vivo). | "Testing previously provided... regarding the surface treatment of the silicone insulation and the biostability of the insulation, is considered relevant to the 5058. Additionally, testing previously provided... regarding biocompatibility, is also considered relevant to the model 5058 lead." |
  | In-Vivo Performance | - Stable electrical performance in a living system (e.g., sensing and pacing thresholds, impedance). | "In-vivo (canine) electrical performance testing" shows "will perform to Medtronic specifications." |

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

• Mechanical & Electrical Testing: The document does not specify the sample size for each individual mechanical or electrical test. It generally states that "testing was performed." The data provenance is internal to Medtronic (Medtronic specifications). These are likely bench tests (laboratory testing).
• Biocompatibility & Biostability: The document highlights that "testing previously provided for the models 5024/5524 (P950089/S9) regarding the surface treatment of the silicone insulation and the biostability of the insulation, is considered relevant to the 5058." Similarly, biocompatibility is deemed relevant from older lead models (e.g., 5023/5523, etc.). This indicates data reuse from previous submissions, implying retrospective use of existing data. The original provenance for those studies is not detailed here but would have been part of their respective 510(k) or PMA submissions.
• In-vivo (canine) electrical performance testing: The document uses the terminology "canine testing." This implies prospective animal studies. The sample size for this specific test is not provided. The country of origin for the canine study is not specified in this summary.

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

This section is not applicable as the document describes the testing of a medical device (pacing lead), not an AI/ML algorithm or a diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is established through direct measurements in mechanical and electrical tests, and observed physiological responses in animal studies (for in-vivo performance) and established biological responses (for biocompatibility).

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as point 3. No human interpretation requiring adjudication is mentioned for establishing the device's performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic tools or AI algorithms where multiple human readers interpret cases, often with or without AI assistance. The Model 5058 is a physical medical device (a pacing lead), not a diagnostic imaging or AI system.

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

This is not applicable. This question pertains to AI algorithms. The Model 5058 is a physical medical device.

7. The Type of Ground Truth Used:

• Direct Measurement/Engineering Specifications: For mechanical and electrical tests, the ground truth is based on established engineering specifications, physical laws, and direct measurements (e.g., resistance values, pull strength in Newtons, successful extension/retraction of a helix).
• Physiological Response (Animal Model): For in-vivo electrical performance, the ground truth is the observed electrical activity and pacing/sensing capabilities within a living canine model, compared against expected physiological responses and performance standards for pacing leads.
• Established Biological Compatibility Standards: For biocompatibility and biostability, the ground truth is established through adherence to recognized international standards and regulatory guidelines for material safety and biological response when implanted in a living organism. This often involves standardized in-vitro and in-vivo tests to assess toxicity, irritation, sensitization, etc.

8. The Sample Size for the Training Set:

This is not applicable. The Model 5058 is a physical medical device, not an AI/ML algorithm that requires a "training set." Its design and manufacturing are based on established engineering principles and prior device experience, not machine learning.

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

This is not applicable for the same reason as point 8.

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