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The MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.

MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 (originally manufactured by Ethicon Endo-Surgery). Following clinical use, the instruments are cleaned, refurbished, tested, inspected, packaged, sterilized with ethylene oxide and returned to the user facility by MEDISISS for an additional clinical use.

This document, K124033, describes a 510(k) premarket notification for the MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9. This is a reprocessing submission, meaning the device is a reprocessed version of an existing device (Ethicon Endo-Surgery Harmonic FOCUS Shears).

The acceptance criteria and the study proving the device meets them are described in terms of "Performance Testing" to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device is reprocessed and returned to the user facility, implying data would be generated from testing reprocessed units.

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 studies listed are likely laboratory-based performance tests rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The performance tests described do not suggest a need for an adjudication method in the context of human expert review.

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 information is not applicable. The device is a surgical instrument (reprocessed shears), not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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 surgical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used

For performance testing (e.g., cutting effectiveness, pull force, thermal analysis), the "ground truth" would be established by objective measurements against predefined engineering specifications and criteria, ensuring the reprocessed device performs comparably to the original predicate device. For biocompatibility and cleaning, the ground truth would be established by laboratory analyses (e.g., measuring residual protein/endotoxins) against established safety limits. The document does not explicitly state the specific thresholds or methodologies for these "ground truths," only that evaluation led to a conclusion of substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Since this is a physical medical device (reprocessed surgical tool) and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The "training" for the reprocessing process would involve establishing and validating the cleaning, refurbishment, and sterilization protocols, but this is distinct from an AI training set.

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

This information is not applicable/not provided as there is no "training set" for an algorithm. For the reprocessing methods, the "ground truth" for validating the cleaning, refurbishment, and sterilization processes would be established through scientific evidence and adherence to recognized standards (e.g., AAMI standards for sterilization, FDA guidance for reprocessing), demonstrating that the reprocessed device meets the same safety and performance requirements as a new device.

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The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation. transection, resection, mobilization, and dissections of tissue.

Reprocessed Electrosurgical Instruments mav consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The distal end of the Ethicon device consists of a scissor distal end configuration. The U.S Surgical device consists of a dissector distal end configuration. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The end effectors are operated by the handpiece handles may be designed to be suppressed and released to activate the instruments end-effector. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360") either direction (using a knob on the handle.)

This document describes the validation and acceptance criteria for reprocessed electrosurgical instruments by SISS Inc. (d.b.a. MediSISS). This is NOT a study of an AI/ML device, but rather a submission for a 510(k) premarket notification for a medical device. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance metrics for individual reprocessed instruments. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices and compliance with established standards.

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

The document mentions "representative samples of reprocessed electrosurgical instruments underwent bench testing." It does not specify the exact sample size for these tests. The provenance of the data is prospective, as it involves testing of the reprocessed devices themselves. The country of origin for the testing is not explicitly stated but can be inferred as the U.S. where the company is based and seeking FDA approval.

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 is not applicable to this type of device submission. The "ground truth" for reprocessed medical instruments is typically established through adherence to validated cleaning, sterilization, and functional performance protocols, and comparison to validated predicate devices, rather than expert consensus on individual "cases."

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of human evaluation of data, often in clinical trials or image interpretation studies, which are not described here. The evaluation of reprocessed instruments primarily involves engineering and microbiological testing.

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 a physical medical device (reprocessed electrosurgical instruments), not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

This is not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context is the established performance, safety, and effectiveness of the original, legally marketed predicate devices, as well as compliance with relevant international standards for medical device reprocessing (cleaning, sterilization, biocompatibility). It also includes the manufacturer's own validated internal functional and mechanical testing results. The goal is to demonstrate that the reprocessed devices meet these established benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of reprocessed physical medical instruments as there's no AI/ML algorithm being developed or trained.

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

This is not applicable as there is no training set.

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The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.

Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.

The provided text is a 510(k) clearance letter from the FDA regarding a reprocessed medical device, specifically MediSISS™ Reprocessed Phacoemulsification Tips/Needles. It does not describe an AI medical device or its performance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is not applicable to this document.

However, based on the provided text, I can extract the following relevant details about the reprocessed medical device itself:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of numerical acceptance criteria for a new AI device or its performance. Instead, it focuses on demonstrating that the reprocessed devices are substantially equivalent to legally marketed predicate devices and meet certain established standards for reprocessing.

Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the document is a validation submission for reprocessed single-use devices. It demonstrates substantial equivalence.

• Cleaning, sterilization, packaging validations, and visual/mechanical testing were performed to show that the reprocessed devices are equivalent to new devices and are safe and effective for their intended use.
• Process validation testing was specifically done to validate the cleaning and sterilization procedures, as well as the device's packaging.
• The conclusion states that the device meets the requirements of the stated standards and embodies technological characteristics identical to the predicate device, implying it is safe, effective, and performs as well as or better than the predicate device.

Information Not Applicable or Available from the Provided Text (for an AI device):

The following points are not directly addressed as the document concerns a reprocessed physical medical device, not an AI medical device:

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 for a reprocessed physical device. Validation involves testing of the reprocessed devices themselves, not a data set.
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 for a reprocessed device would involve analytical and performance testing against established standards, not expert consensus on data interpretation.
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, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device centers on compliance with established reprocessing standards (cleaning, sterilization, material integrity, functional performance) and substantial equivalence to the original predicate devices. This is verified through laboratory testing and engineering analysis rather than clinical outcomes data or expert consensus on diagnostic interpretations.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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The MediSISS Reprocessed Hot Biopsy Forceps and accessories are intended to be used endoscopically to obtain tissue specimens, remove polyps, and cauterize tissue.

Not Found

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for reprocessed hot biopsy forceps, along with a list of substantially equivalent devices and indications for use. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as you have requested.

The letter primarily confirms that the reprocessed devices are substantially equivalent to legally marketed predicate devices and have met the regulatory requirements for medical devices.

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Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.

Not Found

I am sorry, but the provided text does not contain information about explicit acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA, confirming that certain reprocessed endoscopic/laparoscopic trocars and cannulas are substantially equivalent to legally marketed predicate devices.

While the letter mentions "supplemental validation data" was reviewed, it does not describe the specific acceptance criteria for that validation or the details of the study itself. It primarily focuses on the regulatory outcome (substantial equivalence) rather than the technical performance data.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or study design based on the provided text.

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Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.

The provided text is a 510(k) summary for reprocessed electrosurgical electrodes and an FDA clearance letter. It does not contain information regarding acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.

The document explicitly states: "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This indicates that a study demonstrating performance against acceptance criteria, as requested in the prompt, was not performed for this submission.

Therefore, I cannot provide the requested information from the given text.

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The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.

The provided K012667 510(k) summary for "Reprocessed Arthroscopic Shapers" explicitly states that "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This means that a study proving the device meets acceptance criteria, as typically understood in a performance study with quantitative metrics, was not conducted or submitted for this particular clearance.

The basis for clearance was a demonstration of substantial equivalence to existing legally marketed predicate devices (the original single-use arthroscopic shapers) based on shared technological characteristics and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not available in the provided documents because a traditional performance study was not performed.

Here's a breakdown of the information that can be extracted from the provided text, and where gaps exist:

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

• Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics for the reprocessed device versus the original. The implicit acceptance criterion for this 510(k) pathway was that the reprocessed device would be "substantially equivalent" to the predicate device. This equivalence was based on technological characteristics and intended use, rather than a direct comparative performance study.
• Reported Device Performance: No specific quantitative performance metrics comparing the reprocessed device to the new device are reported. The submission states that the reprocessed device has identical materials, dimensions, geometry, method of use, and compatibility with arthroscopic systems as the original single-use shaper.

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 for Test Set: Not applicable. A specific performance "test set" as part of a comparative performance study was not conducted.
• Data Provenance: Not applicable.

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)

• Number of Experts/Qualifications: Not applicable. Ground truth for a comparative performance study was not established, as such a study was not conducted.

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

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

• MRMC Study: No. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is not relevant or applicable.

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

• Standalone Performance: Not applicable. This is a surgical instrument, not an algorithm.

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

• Type of Ground Truth: Not applicable. No performance study requiring ground truth was conducted. The "ground truth" for substantial equivalence was the design specifications and declared functionality of the original, single-use predicate devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a reprocessed medical device, not a machine learning algorithm.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

The devices that are the subject of this submission are used with a pump system to apply sequential compression to the lower limbs. They are made of a variety of materials and come in various sizes. Some are leg wraps and some are foot wraps. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, testing, packaging, and sterilization. It allows the compression limb sleeves to be used several times rather than just once.

The provided 510(k) summary for Surgical Instruments Servicing & Savings, Inc. regarding "Reprocessed Compression Limb Sleeves" indicates that no comparative performance testing or clinical evaluations were conducted as part of this submission. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for novel devices or those with significant performance claims.

Here's a breakdown based on the information provided in the document, and where details are missing:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document explicitly states that "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This means there are no acceptance criteria related to clinical effectiveness, user performance, or comparative performance against the original single-use devices, nor are there any reported performance metrics for such criteria. The acceptance is based on demonstrating substantial equivalence through material and functional identity, and successful reprocessing/sterilization validation.

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

• For functionality testing during reprocessing: Not specified. This typically would involve testing a sample from each reprocessing batch.
• For sterility validation: Not specified. Sterility validation usually involves a defined sample size and method (e.g., sterilization overkill method, bioburden reduction validation), but details are absent.
• For comparative performance/clinical effectiveness: N/A (no such testing was reported).

Data Provenance: N/A for comparative performance/clinical effectiveness studies, as none were conducted. For internal "functionality during reprocessing" and "sterility validation," the data would originate internally from the reprocessor (Surgical Instruments Servicing & Savings, Inc.).

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

N/A. Given that no comparative performance or clinical effectiveness studies were conducted, there was no need for expert ground truth establishment for such purposes.

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

N/A. No comparative performance or clinical effectiveness studies were conducted that would require an adjudication method.

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

N/A. This device is a medical accessory (compression limb sleeve), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not applicable.

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

N/A. This device is a medical accessory, not an algorithm or AI system.

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

N/A. No clinical or comparative performance studies were conducted that would require a ground truth of this nature. The "ground truth" for the submission's claims revolves around the physical and functional identity to the predicate device and the successful execution of reprocessing and sterilization.

8. The sample size for the training set

N/A. This device is a reprocessed physical medical accessory, not a machine learning model, so there is no "training set."

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

N/A. As stated above, there is no "training set" for this device.

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