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The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.

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The provided text describes a 510(k) premarket notification for a medical device called the "IS4/DF4 Port Plug." This document is a letter from the FDA to Oscor Inc. stating that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, expert qualifications, ground truth establishment methods, or details about any studies (standalone or MRMC comparative effectiveness) that would typically be included in a technical report or clinical trial summary.

The content is purely administrative, focusing on the FDA's regulatory decision of substantial equivalence based on the provided indications for use and the device's classification. It states that the device "prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle." This is a functional description, but not a quantifiable performance criterion with an associated study result.

Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth. The document is a regulatory approval letter, not a technical performance report.

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The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.

The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.

This appears to be a 510(k) summary for a medical device (lead extender and adaptor kits), not a study evaluating software or AI performance. Therefore, many of the requested categories for AI/software studies are not applicable.

Here's an analysis based on the provided text, focusing on the available information regarding acceptance criteria and performance testing for these hardware devices:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a "Performance Testing" section which details verification tests conducted on the modified Lead Adaptor Kit and Lead Extender Kit products. The study explicitly states: "The assessment of the material change being made to the Lead Adaptor Kit and Lead Extender Kit products was carried out using Design Controls compliant to 21 CFR 820.30. The safety and effectiveness of the product has been ensured through performance testing."

The conclusion states: "Medtronic has demonstrated that the modifications made to the Lead Adaptor Kit and Lead Extender Kit products described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device(s)."

This implies that the study proving the device meets the acceptance criteria is the comprehensive set of verification tests (Performance, Biocompatibility, Sterilization) conducted under Design Controls (21 CFR 820.30) to establish substantial equivalence to predicate devices. The specific results for each test are not numerical but are reported as "verified" or "passed."

Regarding the AI/Software specific questions (not applicable to this device submission):

This submission is for physical medical devices (lead extenders and adaptors), not a software or AI-driven device. Therefore, the following information is not present and is not relevant to this type of 510(k) submission:

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, as this is a hardware device. No "data" in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by engineering standards and objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For these hardware devices, the ground truth is based on engineering specifications, material properties, and regulatory standards for safety and performance (e.g., electrical impedance measurements, tensile strength, biocompatibility tests).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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1. Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.
2. Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.
3. Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

Not Found

The provided document is a 510(k) clearance letter for a Pacemaker Lead Adapter. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The document only confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

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Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.

Not Found

This document is a 510(k) clearance letter for a medical device, specifically "Pacing Bipolar Lead Adaptors, Models iLINK". It indicates that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a regulatory approval letter, not a technical report detailing the device's validation study. Therefore, I cannot extract the requested information from this text.

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Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.

Not Found

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and study details you requested. The document is a 510(k) clearance letter from the FDA for "Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors". It primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory obligations.

The document does not contain:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test or training sets.
• Details on expert involvement, ground truth establishment, or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.

Therefore, I cannot fulfill your request for this specific document.

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The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard.

*IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

The Model 2872 lead adaptor consists of stainless steel connectors, MP35N conductor coils, and silicone rubber insulation. Also packaged in the kit are wrench / setscrew assemblies, and a tube of medical grade adhesive.

Here's an analysis of the provided K982220 510(k) summary, detailing the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The K982220 submission is for a medical device (Bipolar Lead Adaptor Kit) and the "acceptance criteria" are essentially the performance requirements and specifications that the new device (Model 2872) had to meet to demonstrate substantial equivalence to its predicate device (Medtronic Model 5866-38M Lead Adaptor Kit). The "reported device performance" refers to the results of the tests conducted on the Model 2872.

It's important to note that for this type of device, the "acceptance criteria" are primarily engineering specifications and not diagnostic performance metrics like sensitivity/specificity.

Note on Resistance Criteria: The summary explicitly lists the maximum allowed resistance for the new device as 200Ω for both tip/tip connector block and ring/ring connector block. When comparing to the predicate device, it states the predicate had a maximum of 15Ω for both. This difference is listed as a feature difference, but the submission indicates the new device met its specified requirements, implying the 200Ω was the target for the new device and it achieved it. This suggests a different electrical performance target or design for the new device compared to the predicate, but it was deemed acceptable by Medtronic for substantial equivalence.

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

The 510(k) summary does not explicitly state the sample sizes for the device integrity testing (visual, dimensional, electrical, pull strength, flex life verification). It simply states that "Medtronic, Inc. performed device integrity testing" and "All test results for the device met specified requirements."

Given the nature of bench testing for a lead adaptor, samples would typically consist of a statistically significant number of manufactured units or prototypes to ensure reliability and consistency. However, the exact number is not provided in this summary.

Data Provenance: The studies were performed by Medtronic, Inc., which implies an internal, prospective bench testing approach during the device development and validation process. The country of origin of the data would be the United States, where Medtronic, Inc. is based and where the testing was presumably conducted.

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

This type of information is not applicable to this 510(k) submission. For a device like a pacemaker lead adaptor, "ground truth" doesn't involve expert medical interpretation or diagnosis. Instead, the "ground truth" is established by:

• Engineering specifications and standards: The device must meet predefined electrical, mechanical, and material properties.
• International standards: The device must adhere to standards like ISO 5841-3; 1992 (IS-1).
• Comparison to a legally marketed predicate device: The new device must demonstrate "substantial equivalence" to a device already on the market through performance testing.

Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set. The validation relies on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts evaluate patient data (e.g., medical images) and their discrepancies need to be resolved. For bench testing of a device's physical and electrical properties, there's typically no need for such an adjudication process. Test results are either within specification or not.

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

This is not applicable to this 510(k) submission. This device is a passive, implantable medical component (a lead adaptor), not an AI-powered diagnostic tool or a system that involves human readers interpreting data. Therefore, an MRMC study and AI-related performance metrics are irrelevant for this type of device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable to this 510(k) submission. There is no algorithm involved in the function of a pacemaker lead adaptor. It is a physical connector.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering specifications and performance standards: The device must meet predefined thresholds for resistance, pull strength, flex life, and dimensional accuracy.
• Compliance with international standards: Specifically, the IS-1 standard (ISO 5841-3; 1992) for basic mechanical fit of pacemaker components.
• Demonstration of substantial equivalence to a predicate device: The predicate (Medtronic Model 5866-38M) serves as the benchmark for acceptable performance and safety.

8. The Sample Size for the Training Set

This is not applicable to this 510(k) submission. The device is not based on a machine learning algorithm; therefore, there is no "training set."

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

This is not applicable for the same reason as above (no training set for a non-AI device).

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Lead adapters, including silicone adapter sleeves, when used in conjunction with their accessories, provide a means of securely connecting pace/sense leads with otherwise mechanically incompatible pacemaker devices.

BIOTRONIK A1 Series Lead Adapters and the PEH Adapter Sleeve are designed to be chronically implantable, safe and effective through design functionality, simplicity and material biocompatibility. Both devices were cleared for distribution pursuant to FDA review of the 1990 510(k).

For A 1 Series Lead Adapters, the following changes are proposed:

• a titanium alloy (Ti4) will be used for the manufacture of the device set screw; ●
• . the silicone of the lead connector receptacles and connectors will change from DOW Corning HTV silicones to Silopren LSR-4070;
• NuSil MED 1137 will be used as a silicone tube adhesive; .
• slight design improvements and modifications related to the above described silicone . material changes;
• blister packaging material will change from XT Polymer to PETG; .
• the catalog number will change. .

For the PEH Adapter Sleeve, the following changes are proposed:

• the main silicone-based MOC will change from DOW Corning HTV silicones to . Silopren LSR-4070;
• . the catalog number will change.

The following devices were submitted within the 1990 510(k):

PEH Sleeve: adapts one unipolar lead with 5 mm connector to fit 6 mm connector receptacle.

The provided document largely describes changes proposed for existing BIOTRONIK A1 Series Lead Adapters and PEH Adapter Sleeves, and the FDA's subsequent approval of these changes under a 510(k) submission. It focuses on demonstrating that the changes will not adversely affect the overall safety and effectiveness of the existing, already cleared devices.

As such, this document is a 510(k) premarket notification for device modifications, not for a novel AI device requiring a standalone performance study with a test set, ground truth established by experts, or MRMC studies. The acceptance criteria and "device performance" in this context refer to manufacturing and biocompatibility tests, not the diagnostic or therapeutic performance of an AI algorithm.

Therefore, many of the requested categories for AI device evaluation are not applicable here.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

Acceptance Criteria and Study for BIOTRONIK A1 Series Lead Adapters and PEH Adapter Sleeves (Modified Devices)

Note: This document describes a 510(k) submission for modifications to existing, cleared devices. The "acceptance criteria" and "device performance" primarily relate to engineering, material, and safety testing to ensure the modifications do not compromise the previously established safety and effectiveness. This is not an evaluation of an AI-powered diagnostic or therapeutic device requiring a clinical study with human readers or specific statistical performance metrics.

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

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

• Sample Size: The document does not specify the sample sizes for the individual engineering or material tests. These would typically be determined by internal quality control procedures and regulatory standards for device components/materials.
• Data Provenance: The tests are indicated as "in-vitro tests" and "production and biocompatibility test results," suggesting laboratory-based testing conducted by the manufacturer, BIOTRONIK. No information on geographical origin of data or retrospective/prospective nature is provided beyond the nature of the tests themselves.

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. For this type of device modification submission, "ground truth" is established through adherence to engineering specifications, material properties, and established test methodologies, rather than expert clinical consensus on diagnostic findings.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., radiology reads). The tests described are laboratory/engineering tests with objective metrics.

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 device, and no MRMC study was conducted. The document focuses on material and design changes to an implantable medical device.

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

Not applicable. This is not an AI device, and thus no standalone algorithm performance study was conducted.

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

The "ground truth" for the tests performed on these devices is the adherence to pre-defined engineering specifications, material standards, and safety parameters established by BIOTRONIK and regulatory bodies for the safe and effective functioning of lead adapters.

8. The sample size for the training set

Not applicable. This is not an AI device and does not involve machine learning training sets.

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

Not applicable. No training set was used.

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