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The Streamline 1 Temporary Pacing Leads are indicated for temporary atrial, or atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The devices are supplied sterile and intended for single use only.

Model 6491 Unipolar Pediatric Temporary Pacing Lead: The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6492 Unipolar Temporary Atrial Pacing Lead: The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6494 Unipolar Temporary Myocardial Pacing Wire: The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6495 Bipolar Temporary Myocardial Pacing Lead: The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6500 Unipolar Temporary Myocardial Pacing Lead: The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6491: The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 1). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6492: The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 2). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6494: The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi- filament wire (1) (see Figure 3). One end of this wire has been stripped to have an electrode surface (2). This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle (3). An atraumatic chest needle (4) at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.

Model 6495: The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi- filament lead (see Figure 4) which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6500: The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 5). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body, except the silicone rubber disc (6) in case of atrial application.

This document is a 510(k) summary for Medtronic's Streamline™ Temporary Pacing Leads. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the modifications to the Streamline™ Temporary Pacing Leads "do not affect the intended use of the devices or alter the fundamental scientific technology of the devices." This suggests that the substantial equivalence claim is based on the known performance characteristics of the predicate devices and the minor nature of the changes (pin protector, sterile barrier, packaging, and shelf-life reduction).

Therefore, based on the provided text, I cannot provide the requested information about:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report with detailed performance metrics against acceptance criteria.

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The OL YMPUS Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.

Olympus Unipolar Optical Biopsy Forceps

This document is a 510(k) summary for the Olympus Unipolar Optical Biopsy Forceps. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The provided text from the regulatory submission focuses on:

• Device Identification: Name, common name, classification.
• Predicate Devices: A list of previously cleared devices considered similar.
• Submitter Information: Company and contact details.
• Summary Preparation Date: December 8, 1998.
• Intended Use Statement: "The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract."
• FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing marketing.
• Indications for Use Statement (CDR): Reinforcing the intended use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Medical device regulatory submissions like 510(k)s often do not publicly detail the specific performance acceptance criteria and study results in the summary section. Instead, they refer to internal testing performed by the manufacturer to demonstrate substantial equivalence to predicate devices, which may include bench testing for performance characteristics relevant to the device's function (e.g., biopsy sample size, coagulation effectiveness, mechanical integrity). These details are typically reserved for the full 510(k) submission, which is not fully provided here.

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The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.

The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.

The provided document K964329 describes a 510(k) submission for a Unipolar Electrosurgical Hook Electrode. This device is not a software-driven AI/ML device, and therefore, many of the requested criteria related to AI/ML device performance and study design are not applicable.

Here's an analysis based on the information provided, highlighting the non-applicability of certain AI/ML-specific questions:

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)

• Not Applicable: This device is a physical electrosurgical hook electrode. The "test set" in an AI/ML context refers to a distinct dataset used for evaluating algorithm performance. For this device, "testing" refers to physical compliance testing.
• The performance data focuses on technical characteristics rather than a clinical "test set" in the AI/ML sense.

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: Given this is a physical medical device, there is no "ground truth" in the context of expert labels for an AI/ML system. Ground truth typically refers to verified labels or annotations for data used to train and evaluate AI models. The "ground truth" of performance for this device comes from engineering and material testing standards.

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

• Not Applicable: Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses in clinical studies, particularly for AI/ML development. This device's evaluation does not involve such human-in-the-loop expert adjudication of a test set.

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: MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, on diagnostic tasks using medical images or other data. This device is an electrosurgical tool and does not involve "human readers" interpreting data with or without AI assistance.

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

• Not Applicable: There is no algorithm associated with this physical electrosurgical device, so standalone algorithm performance testing is irrelevant.

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

• Engineering Standards / Physical Property Measurement: The "ground truth" for this device's performance is based on established engineering standards for electrical isolation and validated sterilization protocols. For example, "3000 Volt isolation" would be verified through specific electrical tests.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device. There is no concept of a "training set" for physical electrosurgical tools.

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

• Not Applicable: As there is no training set for an AI/ML model, there is no ground truth establishment for a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary states that "Performance Data" was "Tested to assure 3000 volt isolation and validation to recommended sterilization processes." Additionally, it notes the device's "Technological Characteristics" include a "durable powder coating" and that it is "gas and steam sterilizable."

No Clinical Tests: The document explicitly states "No clinical tests performed."

Conclusion: The device's safety and effectiveness were demonstrated through engineering and performance testing against established standards for electrical isolation and sterilization, rather than through clinical trials or AI/ML specific performance studies. The substantial equivalence claim is based on the device's design, intended use, and technological characteristics being comparable to pre-enactment and existing predicate devices, along with the successful completion of these non-clinical performance tests.

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Not Found

UNIPOLAR IPG GROUND CABLE, Model 5473

The provided document describes performance testing for medical device, likely a component of a larger system. However, the information requested about a study proving a device meets acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers/experts, is not present in the provided text.

The document details device integrity testing for the UNIPOLAR IPG GROUND CABLE, Model 5473, focusing on its physical and functional integrity. It does not describe an AI medical device, diagnostic performance, or a comparative effectiveness study involving human readers.

Here's an analysis of the provided text against your requested points:

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

Missing Information (Not present in the provided text):

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

• Sample sizes for device integrity testing are provided:
  • Autoclave Sterilization: 10 cable assemblies
  • Grounding Clip Life Cycling: 20 cable assemblies
  • Rotational Flex: 8 cable assemblies
• Data provenance (country of origin, retrospective/prospective) is not mentioned. This type of information is typically irrelevant for device integrity testing of physical components.

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 document describes physical device integrity testing, not a diagnostic study requiring expert ground truth.

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

• Not applicable. This describes physical device testing, not a diagnostic study 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

• No, an MRMC study was not done. This document describes physical device integrity testing, not an AI-powered diagnostic study.

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

• Not applicable. This document describes physical device integrity testing, not an algorithm's performance.

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

• For the device integrity testing, the "ground truth" is defined by the test requirements/specifications. For example, "remaining within specification," "grasping and holding a minimum of 2 ounce weight," and "acceptable contact resistance." These are engineering-defined metrics, not clinical ground truth.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is physical device testing, not an AI model.

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

• Not applicable. No training set or ground truth in the context of machine learning is mentioned.

In summary, the provided text details engineering-focused device integrity testing for a physical medical device component. It does not contain any information related to AI devices, diagnostic studies, human reader performance, or typical ground truth establishment methods for such studies.

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The BIOTRONIK TIR and TIJ pacing leads are safe and effective transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.

The leads are manufactured in unipolar and bipolar configurations. The lead body insulation of all TIR/TIJ endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrifilar MP35N. The TIR/TIJ endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has a Physical Vapor Deposition (PVD) of iridium over titanium, creating a fractal-surfaced ball-like microstructure. Passive fixation in the heart's trabeculae is provided by four flexible silicone rubber tines. The ring electrode (anode) of the bipolar lead is made of platinum-iridium, also with a fractal iridium surface treatment. The IS-1 connection system of TIR/TIJ leads complies with the International Standard ISO 5841.3.1992: Low Profile Connectors. The TIJ lead is pre-formed into a " J" shape for optimal positioning in the atrium.

The provided text describes the safety and effectiveness of the BIOTRONIK TIR and TIJ pacing leads. It details pre-clinical testing, clinical evaluation in Europe, and potential complications. However, it does not contain specific acceptance criteria with quantifiable metrics that are then directly proven by study results. Instead, it generally states that "All tests results were within specifications." and refers to "European clinical studies to examine the performance characteristics of the unipolar and bipolar leads." without providing specific numerical targets or the results that met those targets.

Therefore, I cannot populate a table of acceptance criteria and reported device performance as requested.

Based on the available text, here is the information that can be extracted:

1. Table of Acceptance Criteria and 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: Not explicitly stated as a single "test set" sample size. The text mentions that over 100,000 leads (TIR/TIJ and their European versions IRTI/IRTJ) were sold worldwide by 1994. The European clinical studies for models IRTI and IRTJ would have involved a subset of these leads, but the specific number of patients or leads in those studies is not provided in the excerpt.
• Data Provenance: European clinical studies. The data is from Europe and appears to be prospective, as the studies "examined acute and long-term sensing and pacing thresholds, and long-term impedance's" for the European versions of the leads (models IRTI and IRTJ).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the text. The text refers to "European clinical studies" but does not detail the methodology for establishing ground truth within those studies, such as the use of expert adjudication for outcomes.

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

• This information is not provided in the text.

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

• No, this type of study was not done. The device is a cardiac pacing lead, not an AI-assisted diagnostic tool for human readers.

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

• This question is not applicable. The device is a physical cardiac pacing lead, not an algorithm.

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

• For the European clinical studies, the ground truth would inherently be based on clinical outcomes data (e.g., measured pacing and sensing thresholds, impedance, and the occurrence of complications) observed in patients receiving the implanted leads.

8. The sample size for the training set

• This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set in the typical sense. The "training" in this context refers to manufacturing validation and pre-clinical testing, not data-driven model training.

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

• This question is not applicable for the reasons mentioned above. For the pre-clinical and qualification testing (which could be considered analogous to "training" or development/validation), the "ground truth" was established through engineering specifications, material science standards, and established medical device testing protocols (e.g., biocompatibility testing, corrosion studies, physical property tests like crimp/weld strength) that define expected performance and material properties. "All tests results were within specifications" indicates adherence to these established standards.

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