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The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed Hand Activated Sealer/Divider:

Summary of Acceptance Criteria and Study Findings for Reprocessed Hand Activated Sealer/Divider

This submission is for a reprocessed device, thus the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the reprocessed device performs identically to its predicate device and original intent, and that the reprocessing itself is safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

• Biocompatibility
• Validation of reprocessing
• Sterilization Validation
• Function test(s)
• Packaging Validation | "Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider perform as originally intended."
  "Conclusion: Ascent Healthcare Solutions concludes that the Reprocessed Hand Activated Sealer/Divider are safe, effective, and substantially equivalent to the predicate device as described herein." |

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

The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many reprocessed devices were tested for each performance criterion.

• Sample Size: Not explicitly stated as a numerical value (e.g., "N=X devices"). The text mentions "Each individual Hand Activated Sealer/Divider is tested for appropriate function," suggesting every unit undergoes some functional testing. For other tests like biocompatibility or sterilization, it's implied that a sufficient, representative sample was used according to regulatory standards for validation, but the exact number is not provided.
• Data Provenance: The studies were conducted as "Bench and laboratory testing" by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical studies. Given it's a reprocessed device and the tests are focused on material, functional, and reprocessing validation, these are typical laboratory-based studies.

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

N/A. This type of submission (510(k) for a reprocessed electrosurgical device) focuses on engineering and material science testing, rather than interpretation of medical images or clinical outcomes by medical experts to establish a "ground truth." The "ground truth" here is adherence to engineering specifications and performance within established safety and effectiveness parameters, which would be assessed by engineers, quality control specialists, and possibly microbiologists. The document does not describe the use of medical experts for establishing ground truth for these tests.

4. Adjudication Method for the Test Set

N/A. As with point 3, this is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads) where there's subjectivity and potential disagreement. The performance tests described (biocompatibility, sterilization, function, etc.) are typically objective, pass/fail criteria and do not involve human adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is completely irrelevant for this device and type of submission. MRMC studies are used to evaluate the diagnostic performance of imaging devices or algorithms where multiple readers interpret cases. This submission is for a reprocessed surgical instrument.

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

N/A. This is not an AI algorithm or a diagnostic device. It's a reprocessed surgical instrument. The device itself operates as designed (without "human-in-the-loop" once it's in use, other than being operated by the surgeon) and its performance is assessed against its original specifications and the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is multifaceted, rooted in engineering specifications, established regulatory standards, and the performance characteristics of the original (predicate) device.

• Predicate Device Performance: The primary ground truth is that the reprocessed device must perform "identically" and "as originally intended" compared to the new, predicate device.
• Safety Standards: Ground truth for biocompatibility relates to accepted material safety standards.
• Sterilization Standards: Ground truth for sterilization validation relates to established industry and regulatory standards for achieving sterility (e.g., sterilization assurance level, SAL).
• Functional Specifications: Ground truth for function tests would be the original engineering specifications for force, sealing ability (e.g., vessel seal strength), electrical integrity, etc., of the new device.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of this device. A training set is used for machine learning models. This submission describes the testing and validation of a reprocessed medical device through traditional engineering and quality control methods.

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

N/A. As mentioned in point 8, there is no training set for this device.

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Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.

Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.

The provided documents do not contain the detailed information necessary to fully answer all aspects of your request, as they pertain to the 510(k) summary for a reprocessed medical device rather than a new device with AI components. The study described focuses on demonstrating the substantial equivalence of reprocessed endoscopic instruments to predicate devices through bench and laboratory testing.

Here's a breakdown of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Instruments. This included the following tests:

• Biocompatibility
• Validation of reprocessing
• Sterilization Validation
• Function test(s)
• Packaging Validation."

The conclusion is: "Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum residual protein levels, specific electrical resistance ranges for cautery function) and the exact reported performance values for each of these tests are not provided in this summary. Therefore, a detailed table cannot be created. The ground truth for this type of testing is typically established by pre-defined engineering specifications, regulatory standards, and comparison to the performance of the original predicate device.

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

The document does not specify the sample sizes used for each of the bench and laboratory tests. It generally refers to "testing" without providing numerical details for the test sets.

The data provenance is from bench and laboratory testing of reprocessed medical devices, rather than clinical data from specific countries. It is inherently prospective in the sense that Ascent Healthcare Solutions performed these tests for this 510(k) submission.

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

This type of information is not applicable in the context of this 510(k) summary. The "ground truth" for the performance of a reprocessed medical device is established through objective physical, chemical, and biological testing against predefined engineering and regulatory standards, not through expert consensus on interpretations like with diagnostic imaging.

4. Adjudication Method for the Test Set:

This is not applicable to the type of bench and laboratory testing described. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints.

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. This submission is for reprocessed endoscopic instruments, which are physical surgical tools, not AI algorithms. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable. This submission is for a physical medical device, not an algorithm.

8. The Sample Size for the Training Set:

This is not applicable as there is no AI or algorithm involved that would require a training set.

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

This is not applicable as there is no AI or algorithm involved that would require a training set.

In summary, the provided document is a 510(k) summary for a reprocessed physical medical device. It describes bench and lab tests to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. It does not involve AI, clinical data from human subjects for ground truth establishment, or multi-reader studies.

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When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.

Ascent Healthcare Solutions' Reprocessed Compression Sleeves were tested against several acceptance criteria through bench and laboratory testing. The study proved that the reprocessed sleeves perform as originally intended, demonstrating safety and effectiveness compared to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly states that "Bench and laboratory testing was conducted," implying a controlled experimental environment rather than patient data.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. Given that the testing involved "bench and laboratory testing" rather than clinical assessment or diagnostic evaluations, the concept of "ground truth established by experts" as typically understood in AI/medical imaging studies may not directly apply. The evaluation would likely have been based on established engineering and materials science standards.

4. Adjudication Method:

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The device is a reprocessed physical medical device, not a diagnostic algorithm or AI system intended to assist human readers.

6. Standalone Performance (Algorithm Only):

Not applicable. The device is a physical medical device (compression sleeve), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing was based on established engineering and safety standards for medical device function and material properties, as evidenced by the mention of "Biocompatibility," "Validation of reprocessing," and "Function test(s)." It was not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive device. The goal was to show that the reprocessed device met the performance characteristics of its original, non-reprocessed counterparts.

8. Sample Size for the Training Set:

Not applicable. The device is a reprocessed physical medical device, not an AI model requiring a training set. The "reprocessing" itself involves a set of procedures that are validated, rather than an algorithm that is "trained."

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

Not applicable, as there is no training set for this type of device. The reprocessing process itself would be validated against established standards to ensure the device performs as intended after reprocessing, which serves a similar role to "ground truth" for the manufacturing/reprocessing process.

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The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

The reprocessed Biosense Webster® Coronary Sinus (CS) EZ STEER™ Diagnostic Electrophysiology (EP) Catheter (hereinafter CS Bi-Directional Diagnostic EP Catheter) is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a braided bi-directional deflectable tip section containing platinum electrodes that can be used for recording and stimulation. Two asymmetric curve types, DF and FJ, are available providing two 180° opposed, single plane curves. The rocker lever located on the handpiece is used to deflect the tip section. A Friction Control Knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip at the preferred site.

The provided document (K100254) describes the performance data for a reprocessed medical device, the "Reprocessed CS Bi-Directional Diagnostic Electrophysiology Catheter." However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device.

This submission is for a medical device reprocessed by Ascent Healthcare Solutions that is "substantially equivalent" to a predicate device. The performance data presented is focused on demonstrating that the reprocessed device performs as originally intended, which is typical for a 510(k) submission for reprocessed devices rather than a novel AI/algorithm.

Therefore, most of the specific questions regarding AI performance criteria, sample sizes for AI test sets, expert ground truth, MRMC studies, or training sets cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: The document implies that the acceptance criteria are that the reprocessed device performs "as originally intended" and is "safe, effective, and substantially equivalent to the predicate devices." No specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) are provided for the reprocessed catheter itself in terms of electrophysiological performance.

• Reported Device Performance:

  • Bench and laboratory testing was conducted.
  • Tests included: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.
  • Conclusion: "Performance testing demonstrates that reprocessed electrophysiology catheters perform as originally intended."

  Table (Based on the document):

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Each individual CS Bi-Directional Diagnostic EP Catheter is tested for appropriate function," which suggests a 100% inspection or a statistically determined sample from reprocessed lots, but the exact numbers are not given.
• Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions.

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 is a reprocessed physical device, not an AI/algorithm that requires expert-established ground truth for its performance evaluation in the way an AI diagnostic tool would. The "ground truth" for the device's function is its intended mechanical and electrical performance.

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

• Not Applicable. As above, this is for a physical device performance, not an AI output requiring expert 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. This is not relevant for the type of device and study described. There is no AI component or human reader interaction with an AI.

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

• No. There is no algorithm or AI component mentioned.

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

• The "ground truth" for this device's performance would be engineering specifications, established functionality of the original predicate device, and compliance with reprocessing standards. It's not a medical diagnostic ground truth like pathology or expert consensus on an image.

8. The sample size for the training set

• Not Applicable. There is no AI or algorithm that would require a training set.

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

• Not Applicable. There is no AI or algorithm that would require a training set.

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The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.

The Ultrasonic Curved Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including 5mm in diameter. The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are designed to operate with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE).

The provided documentation describes the reprocessing of an Ultrasonic Curved Shears device and its substantial equivalence to a predicate device. The information details the acceptance criteria through performance testing, but not a specific study with a quantitative measure against criteria in a table format as requested.

Here's an analysis of the provided information, addressing your points:

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

The document lists categories of performance testing but does not provide specific quantitative acceptance criteria or detailed reported performance values. It states generally that "Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended."

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

The document does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

This information is not provided in the document. The performance tests appear to be laboratory and bench testing, not clinical studies involving human observers for establishing ground truth.

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

This information is not applicable and not provided. The testing described is technical performance testing, not a clinical trial with expert 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

An MRMC comparative effectiveness study was not conducted. This document describes the reprocessing of a surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human reader performance.

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

This is not applicable to the device described. The device is a reprocessed surgical instrument, not an algorithm.

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

For the "Function test(s)," the ground truth would likely be the original design specifications and performance characteristics of the predicate device. For "Biocompatibility," "Validation of reprocessing," "Sterilization Validation," and "Packaging Validation," the ground truth is established by adherence to recognized standards and protocols for reprocessing, sterilization, and packaging of medical devices. No clinical outcomes data or pathology is mentioned for establishing ground truth in this context.

8. The sample size for the training set

This is not applicable as the device is a reprocessed physical instrument, not an AI model.

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

This is not applicable as the device is a reprocessed physical instrument, not an AI model.

Summary of the Study:

The study described is a series of bench and laboratory tests designed to demonstrate that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist performs as originally intended by the manufacturer of the predicate device (Harmonic Focus Curved Shears and Torque Wrench, K063192). The core of the argument for substantial equivalence relies on:

• Identical Design and Materials: The reprocessed device is stated to have identical design, materials, intended use, mechanism of action, mechanical design, size, and materials as the predicate device.
• Reprocessing Validation: Ascent Healthcare Solutions' reprocessing procedure includes removal of soil, decontamination, and individual functional testing of each reprocessed unit.
• Performance Testing Categories: The testing covered Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), and Packaging Validation.

The conclusion is that these tests demonstrate safety, effectiveness, and substantial equivalence to the predicate device. The document does not provide the granular details of the specific acceptance criteria (e.g., a specific force requirement for a function test) or the quantitative results of these tests, but rather states that performance was "demonstrated."

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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.

The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.

Trocar Obturator is available in bladeless configuration sized 5 mm.. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury

The reprocessed device has the same intended use as the original device and does not incorporate new technology or design changes.

The provided text is a 510(k) premarket notification for reprocessed trocars. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, device performance data, study design, or validation results needed to answer your request fully.

The document states that a previous 510(k) (K062497) included information for trocars limited to one reprocessing cycle, and this current 510(k) (K100080) "includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This implies a study was conducted, but the details of that study are not present in the provided excerpts.

To address your request, I will indicate where the information would typically be found in a complete submission or what is inferred from the available text.

Here's a breakdown of the requested information based on the provided text and general 510(k) content expectations:

1. Table of acceptance criteria and the reported device performance

Explanation: The document explicitly states: "This 510(k) includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This sets the acceptance criteria at maintaining safety and effectiveness. However, the specific metrics and the actual performance results demonstrating this are not included in the provided pages.

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 provided in the excerpt. A complete 510(k) submission for reprocessing validation would typically include specific numbers of devices tested.
• Data Provenance: Not stated in the excerpt. It would usually be prospective testing of reprocessed devices.
• Country of Origin: Not specified for the data itself, but the applicant (Ascent Healthcare Solutions) is located in Phoenix, Arizona, USA, and the manufacturing site is in Lakeland, FL, USA.

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/Not mentioned. This type of information (expert review for ground truth) is more common for diagnostic imaging AI submissions. For a reprocessed medical device, the "ground truth" is typically established through direct physical, mechanical, and functional testing of the device itself against established specifications, rather than expert interpretation of data.

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

• Not applicable/Not mentioned. Adjudication methods are typically used in clinical or image-based studies where expert consensus is required for ground truth determination. Device performance testing for reprocessing generally involves objective measurements.

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 submission for a reprocessed surgical device, not an AI or diagnostic imaging device that would typically involve an MRMC study.

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

• Not applicable. This is for a physical medical device, not an algorithm. The performance being evaluated is that of the reprocessed trocar itself. The "standalone performance" here would effectively be the results of the physical and functional tests on the device.

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

• The "ground truth" for this type of device validation would be established through:
  • Validated test methods: Objective measurements of physical, mechanical, and functional properties (e.g., integrity, sealing, penetration force, material strength, sterility, biocompatibility) according to pre-defined specifications and industry standards.
  • Comparison to original device specifications: Ensuring the reprocessed device performs identically to the new, predicate device.
  • Safety and effectiveness demonstration: Ensuring no compromise in patient safety or clinical effectiveness due to reprocessing.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning submission with a "training set." The validation involves direct testing of the reprocessed devices.

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

• Not applicable, as there is no "training set" in this context.

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The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general; plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.

The Ultrasonic Coagulating Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054).

The provided document describes the 510(k) summary for Reprocessed Ultrasonic Coagulating Shears. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through a clinical study. The performance data presented focuses on verifying that the reprocessed device performs as originally intended, matching the predicate device.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance that a new device would need to meet. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device (Harmonic Wave Coagulating Shears, K062000). The "acceptance criteria" are implied to be that the reprocessed device performs identically to the predicate device in terms of design, materials, intended use, mechanism of action, claims, clinical applications, patient population, and performance specifications.

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

The document explicitly states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Coagulating Shears." However, it does not specify the sample sizes used for these tests.

The data provenance is from bench and laboratory testing, not human clinical data. There is no information about country of origin, retrospective, or prospective nature of this "test set" in the context of clinical trials, as it's not a clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in the document. The study described is a series of bench and laboratory tests to confirm the physical and functional characteristics of a reprocessed device compared to its original specifications, not a study involving human or image-based ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document, as it's not a study involving human reader interpretation or adjudication. The "test set" here refers to physical items undergoing laboratory testing, not clinical cases.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the substantial equivalence of a reprocessed medical device through bench and laboratory testing, not on the comparative effectiveness of human readers with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This document concerns a reprocessed physical medical device (ultrasonic shears), not a software algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the original specifications and performance of the new (predicate) ultrasonic coagulating shears. The reprocessed device is tested against these established standards to demonstrate that it performs "as originally intended." This includes:

• Biocompatibility standards.
• Validated reprocessing protocols.
• Sterilization efficacy.
• Appropriate function of components (mechanical, electrical, etc.).
• Packaging integrity.

8. The Sample Size for the Training Set

This information is not applicable. There is no training set in the context of machine learning or AI involved in this submission.

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

This information is not applicable. Since there is no training set mentioned, there is no ground truth established for it in this context.

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Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.

3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter 3-D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is 10 French with a 90 cm insertion length.

The provided text describes a 510(k) summary for "Reprocessed 3D Diagnostic Ultrasound Catheters." This submission is for a reprocessed medical device, not a new AI-powered diagnostic system. Therefore, most of the requested information regarding AI performance metrics, ground truth, expert consensus, and training/test sets is not applicable to this document.

The document focuses on demonstrating that the reprocessed devices perform as originally intended and are substantially equivalent to the predicate device.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This submission is for reprocessed physical devices, and the "test set" refers to the physical units tested in bench and laboratory settings, not a data set for an algorithm. The document does not specify the number of reprocessed units tested for each criterion.

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

• Not Applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant here. The "ground truth" for a reprocessed device is whether it meets its original performance specifications after reprocessing.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers on image interpretation. This is not a human-in-the-loop diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This is not an MRMC study. It is a submission for a reprocessed physical medical device.

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

• No. This device is a physical diagnostic ultrasound catheter, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" for this type of submission is the original performance specifications and functional requirements of the predicate device. The studies conducted (bench, lab, biocompatibility, sterilization, function, packaging validation) aim to prove that the reprocessed device meets these identical standards.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI algorithm for this submission.

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

• Not Applicable. There is no "training set" or explicit "ground truth" establishment in the AI sense for this submission.

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Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

The provided text describes the 510(k) summary for Ascent Healthcare Solutions' Reprocessed Electrophysiology Catheters (K090323). This submission focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but it does not include a study design or acceptance criteria related to a diagnostic algorithm or AI performance.

Therefore, I cannot provide information on acceptance criteria for a diagnostic device's performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided regulatory document.

However, I can extract the information regarding the performance data presented in the 510(k) summary, which focuses on the safety and effectiveness of the reprocessing procedure and the reprocessed physical device, rather than the diagnostic accuracy of an algorithm.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as pertaining to reprocessed physical device, not AI/diagnostic algorithm performance):

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The document mentions "Bench and laboratory testing," implying physical testing of reprocessed devices, but does not quantify the number of units tested.
• Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical data rather than bench testing.

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

• Not Applicable. This submission concerns the reprocessing of a physical medical device, not a diagnostic algorithm that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this submission would be defined by engineering specifications and industry standards for medical device performance and reprocessing.

4. Adjudication method for the test set:

• Not Applicable. As explained above, this is not a study assessing diagnostic accuracy requiring expert 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. This type of study is completely unrelated to the content of this 510(k) submission. No AI component is mentioned or evaluated.

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

• No. There is no algorithm or AI component in this device.

7. The type of ground truth used:

• The "ground truth" for the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) would be based on established engineering specifications, industry standards, and regulatory requirements for medical devices and their reprocessing. For example, sterilization validation would have standards for sterility assurance levels, and function tests would have specified electrical and mechanical performance criteria that the reprocessed catheters must meet to perform "as originally intended," mirroring the predicate device.

8. The sample size for the training set:

• Not Applicable. There is no training set mentioned or implied as this is not an AI or diagnostic algorithm submission.

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

• Not Applicable. There is no training set.

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text, a 510(k) summary for Reprocessed Electrophysiology Catheters, does not explicitly define quantitative acceptance criteria for device performance in a table format. Instead, it broadly states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."

The closest approximations to "acceptance criteria" are the types of tests performed. Since specific numerical targets for these tests are not provided, I will present the tests as the criteria implied to demonstrate safety and effectiveness.

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

The document does not provide specific sample sizes for the test sets used in biocompatibility, reprocessing validation, sterilization validation, function tests, or packaging validation. It only states that "Bench and laboratory testing was conducted." The data provenance is also not specified beyond being "bench and laboratory testing," implying it was conducted by Ascent Healthcare Solutions, likely in a controlled, prospective manner to demonstrate equivalence. There is no mention of country of origin of the data.

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

This information is not provided in the document. The study described is a series of bench and laboratory tests to demonstrate device performance and equivalence to predicate devices, not a clinical study involving diagnosis or interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is focused on bench and laboratory testing of the reprocessed device itself, not on human interpretation or diagnostic accuracy where adjudication would be relevant.

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

An MRMC comparative effectiveness study was not conducted. The device is a reprocessed medical catheter, not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used

For the performance testing (biocompatibility, reprocessing, sterilization, function, packaging), the ground truth was established through validated laboratory methods and engineering specifications designed to ensure the reprocessed device meets the original design requirements and safety standards of the new predicate devices. For demonstrating equivalence, the ground truth was the specifications and performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This document describes the re-processing of medical devices, not the development or training of an AI algorithm.

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

This information is not applicable as there is no training set mentioned or implied in the context of this device.

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