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Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures. Trocars are single patient used devices.

AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.

The provided text describes a 510(k) submission for reprocessed disposable trocars by Adven Medical, Inc. (AMI). It focuses on establishing substantial equivalence to new disposable trocars and the reprocessing protocol. However, the document does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the specifics of a study proving device performance against those criteria.

Specifically, the document states: "AMI has performed numerous tests to validate its reprocessing protocol." but does not elaborate on:

• The specific acceptance criteria used for these tests.
• The reported performance statistics from these tests.
• The sample size, data provenance, number of experts, adjudication methods, or ground truth details for these tests.
• Any information regarding MRMC studies or standalone algorithm performance.

Therefore, many sections of your request cannot be fulfilled with the provided text. I will provide the information that is available.

Acceptance Criteria and Study for Reprocessed Disposable Trocars

Based on the provided text, the primary "acceptance criteria" for the reprocessed trocars hinge on demonstrating that they remain "safe and effective for its intended use" after reprocessing, are "able to withstand the necessary cleaning and sterilization process," and that "the physical characteristics or quality of the device will not be adversely effected." The foundational study mentioned is the validation of AMI's reprocessing protocol.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states: "AMI has performed numerous tests to validate its reprocessing protocol." However, it does not specify the sample size for these tests.
• Data Provenance: The origin of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided text. It can be inferred that the testing would have been conducted primarily in the USA, as AMI is a US-based company submitting to the US FDA. The nature (retrospective/prospective) is also not specified.

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 document. The validation tests mentioned likely refer to engineering and biocompatibility testing rather than expert-based clinical ground truth.

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

• This information is not provided in the document.

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 MRMC study information is provided. This type of study is not relevant to the validation of a reprocessed surgical instrument.

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

• This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.

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

• For a reprocessed surgical instrument, the "ground truth" for the validation tests would likely involve a combination of:
  • Functional Testing: Demonstrating the device continues to perform its intended mechanical function (e.g., proper insertion, seal integrity, port function) after reprocessing.
  • Material Integrity Testing: Ensuring no degradation of materials, corrosion, or structural compromise.
  • Cleaning Efficacy/Sterilization Validation: Demonstrating successful removal of bioburden and successful sterilization, typically through laboratory methods (e.g., protein residue tests, sterility tests).
  • Biocompatibility Testing: Ensuring reprocessed devices remain biocompatible.
• Specific details on how these were established are not provided, beyond the general statement of "numerous tests".

8. The sample size for the training set:

• This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.

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

• This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.

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Sequential compression sleeves are intended to increase venous return from the lower extemities in as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only.

AMI intends to market reprocessed sequential compression sleeves and wraps. Reprocessing sequential compression sleeves and wraps is performed by AMI to AMI protocol Number 40009. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices. AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Sequential compression sleeves and wraps are designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism. AMI intends to reprocess disposable sequential compression sleeves and wraps manufactured by Kendall (sleeves and foot wraps), Huntleigh and Plexipulse.

The provided text describes a 510(k) summary for "Reprocessed Used Disposable Sequential Compression Sleeves / Wraps" by 4dven Medical, Inc. This document focuses on the reprocessing of medical devices, specifically sequential compression sleeves and wraps, rather than the development and performance of entirely new medical devices.

Therefore, the typical acceptance criteria and study data associated with demonstrating the performance of a novel device (e.g., accuracy, sensitivity, specificity studies with ground truth) are not applicable in this context.

Instead, the documentation addresses the substantial equivalence of the reprocessed devices to legally marketed predicate devices, focusing on the reprocessing process itself to ensure the reprocessed devices are safe and effective for their intended use.

Here's a breakdown of why many of your requested points are not directly addressed and what aspects are covered:

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

• Not applicable in the traditional sense. For reprocessed devices, the "acceptance criteria" relate to the ability of the reprocessing procedure to restore the device to a patient-ready state without adversely affecting its physical characteristics, quality, safety, and effectiveness. The performance goal is to match that of the new, predicate device.
• The document states: "AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use."
• Implied Acceptance Criteria:
  • Withstand cleaning and sterilization.
  • Physical characteristics unaffected.
  • Quality unaffected.
  • Safety maintained.
  • Effectiveness maintained.
• Reported Device Performance: The document does not provide quantitative performance metrics for the reprocessed devices in the way a new device would (e.g., specific flow rates, pressure measurements after reprocessing vs. new). Instead, the "performance" is implicitly demonstrated by comparing them to the predicate devices. The FDA's 510(k) clearance implies that these criteria were met through the submitted reprocessing protocol.

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 type of information is typically for clinical performance studies of new devices. For reprocessing, the "test set" would be samples of reprocessed devices that undergo various validation tests (e.g., sterility testing, material integrity, functional testing) to ensure they meet specifications after reprocessing. The document does not detail these validation sample sizes or provenance.

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. Ground truth establishment using experts is for diagnostic or predictive devices. For reprocessed devices, compliance with engineering and material standards, sterility, and functional equivalence to the original device serves as the "truth." This is typically assessed through laboratory testing and engineering analysis rather than expert human interpretation of results.

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

• Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, usually in clinical image review or similar subjective assessments.

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 for evaluating the performance of diagnostic imaging devices, often involving AI. This product is a reprocessed medical device, not a diagnostic AI tool.

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable in the traditional sense. For reprocessed devices, the "ground truth" for the reprocessing process itself is established by demonstrating that the reprocessed device meets the original device's specifications for safety, effectiveness, and performance. This involves:
  • Sterility testing: Ensuring no microorganisms remain.
  • Biocompatibility testing: Ensuring no harmful residues.
  • Material integrity/functional testing: Ensuring the device still works as intended and its physical properties are not degraded.
  • Comparison to original specifications: Proving the reprocessed device functions equivalently to a new device.

8. The sample size for the training set

• Not applicable. Training sets are for machine learning algorithms.

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

• Not applicable. Training sets are for machine learning algorithms.

Summary of Relevant Information from the Provided Text:

• Device Name: Reprocessed Used Disposable Sequential Compression Sleeves / Wraps
• Intended Use (Indications for Use): To increase venous return from the lower extremities, as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non-ambulatory patients.
• Reprocessing Protocol: AMI Protocol Number 40009 (details not provided in the excerpt).
• Predicate Device: Sequential compression sleeves and wraps sold new by Kendall under 510K 942664.
• Substantial Equivalence Claim: AMI claims the reprocessed devices are substantially equivalent to the new Kendall sleeves/wraps.
• Basis for Substantial Equivalence (as per FDA CPG #7124.16 for reusability):
  • Able to withstand necessary cleaning and sterilization.
  • Physical characteristics or quality of the device will not be adversely affected.
  • Device remains safe and effective for its intended use.

In conclusion, this 510(k) summary is for the reprocessing of an existing medical device, not for the development of a new device or an AI application. Therefore, the questions related to clinical study design, expert review, and AI performance metrics are not applicable to the information provided. The acceptance criteria revolve around the successful validation of the reprocessing procedure to ensure the device remains safe and effective, and substantially equivalent to its new counterpart. The study proving this would involve detailed engineering, sterility, and functional testing of the reprocessed devices, which are not detailed in this high-level 510(k) summary.

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Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

This is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable arthroscopic blades and burs (K012694). This document pertains to the regulatory clearance of a reprocessed medical device, not a new AI-powered diagnostic or treatment device. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic accuracy metrics, MRMC studies, or training/test set details) is not applicable here.

The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, asserting that the reprocessed devices remain safe and effective for their intended use after reprocessing.

Here's an attempt to address the requested information based on the provided text, noting where specific AI/ML-related questions are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are primarily focused on demonstrating that the reprocessed devices:

• Can withstand the necessary cleaning and sterilization process.
• Do not have their physical characteristics or quality adversely affected.
• Remain safe and effective for their intended use.
• Are substantially equivalent to the new, legally marketed predicate device.

The document does not provide a table with quantitative performance metrics typical for new device clearances. Instead, it relies on the assertion that the reprocessed product is substantially equivalent to a cleared predicate.

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

The document does not specify a "test set" in the context of performance data, as would be expected for a diagnostic or AI device. The submission focuses on the reprocessing protocol (Protocol Number 40006) for commercially available devices. The data provenance would relate to the validation of this reprocessing protocol, but specific numbers or details are not provided in this summary.

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

Not applicable. This is not a study assessing the diagnostic accuracy or performance of an AI model with ground truth established by experts.

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. This device is not an AI-powered tool for human readers.

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)

The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the original, new single-use device (the predicate device, Smith & Nephew Dyonics K953695) and the evidence that the reprocessing protocol maintains these characteristics. This is achieved through validation of the cleaning, sterilization, and functional integrity after reprocessing, rather than a diagnostic "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.

AMI intends to reprocess all brands of used disposable surgical saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.

Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

AMI intends to market used disposable surgical blades, burs, bits and taps that have been reprocessed. Reprocessing blades, burs, bits and taps is performed by AMI to AMI protocol Number 40014. "Reprocessed," means all operations performed to render a contaminated singleuse device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals).

AMI is a "third party reprocessor" and reprocesses used single-used medical devices.

Used blades, burs, bits and taps that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the item is not reprocessed at all) or anytime during subsequent reprocessings.

AMI believes that used single-use blades, burs, bits and taps can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.

Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.

AMI reprocessed blades, burs, bits and taps are composed of the same materials as currently marketed blades, burs, bits and taps sold new.

Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) are reprocessed by Adven Medical, Inc.

The information provided does not contain details about specific acceptance criteria or a study that evaluates device performance against such criteria. The document is a 510(k) summary for reprocessed surgical blades, burs, bits, and taps, outlining the manufacturer's intent to market these reprocessed devices and asserting their substantial equivalence to new, disposable devices already on the market.

Instead of performance metrics, the key aspects discussed are:

• Substantial Equivalence: The primary claim is that the reprocessed devices are substantially equivalent to new disposable devices. This is based on their ability to withstand cleaning and sterilization, their material composition (same as new devices), and their intended use.
• Reprocessing Protocol: Adven Medical, Inc. (AMI) has a specific protocol (Number 40014) for reprocessing these devices, and devices that do not meet this protocol are rejected. This protocol itself acts as a form of internal acceptance criteria for reprocessing.
• Regulatory Compliance: The FDA review confirms that the device is substantially equivalent for the stated indications of use and can be marketed under general controls provisions of the Act.

Therefore, I cannot populate the requested tables and information based on the provided text, as it does not describe a performance study with acceptance criteria in the typical sense for a medical device. It focuses on the process of reprocessing and the assertion of equivalence to existing devices, rather than a standalone performance evaluation with specific numerical targets.

If there were a study, one might expect to see:

• Mechanical testing (e.g., sharpness, torque, tensile strength) before and after reprocessing.
• Biocompatibility testing to ensure no harmful residues.
• Sterility assurance level (SAL) validation.

None of these are present in the provided text.

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