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MEDISISS Reprocessed Shavers and Burs are powered arthroscopic accessories intended for use in orthopedic joint surgery.

Arthroscopic devices reprocessed by MEDISISS include burs and blades at the end of a long rod that rotates within a hollow stainless steel housing. The housing has an opening on one side of the distal end, allowing the cutting tip to resect tissue while protecting adjacent material with the housing on the opposite side of the bur or blade. This system attaches to a motorized hand piece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site. Devices are provided sterile.

The provided document describes the 510(k) Notification for "MEDISISS Reprocessed Arthroscopic Shavers and Burs". This is a medical device submission, and the content suggests it is not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing and performance metrics (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance, effect size of human improvement with AI) are not applicable.

However, I can extract information related to the device's performance testing and substantial equivalence.

Here's the closest representation of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Regarding the study that proves the device meets the acceptance criteria:

The document states: "Performance Testing: The functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices. The patient contacting materials are either identical to the materials of the predicate devices, or have been fully evaluated for biocompatibility and functionality."

This indicates that internal performance testing and biocompatibility evaluations were conducted to demonstrate equivalence to the predicate devices. The specific details of these studies (e.g., protocols, raw data, statistical analysis) are not present in this summary but would have been part of the full 510(k) submission.

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

• Sample size: Not specified in the provided summary.
• Data provenance: Not specified in the provided summary. This would likely involve testing of reprocessed devices against new predicate devices, or comparison of properties.

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 as this is not an AI/ML medical device and does not involve ground truth establishment by experts in the context of diagnostic interpretation.

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

• Not applicable for this type of device submission.

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/ML medical device submission.

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

• Not applicable as this is not an AI/ML medical device submission.

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

• For the "Performance Testing" mentioned, the "ground truth" or reference standard would be the characteristics and performance of the original, new predicate devices. Equivalence was shown through direct comparison of functional properties and material characteristics, rather than diagnostic "ground truth."

8. The sample size for the training set

• Not applicable as this is not an AI/ML medical device submission.

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

• Not applicable as this is not an AI/ML medical device submission.

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MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.

The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.

The provided text is a 510(k) notification for MEDISISS Reprocessed ENT Ablation Wands (Coblators). This document is for a medical device (an ablation wand) and not for an AI/ML powered medical device. Therefore, the information requested such as "acceptance criteria and the study that proves the device meets the acceptance criteria", "sample size used for the test set and the data provenance", "number of experts used to establish the ground truth", "adjudication method", "multi reader multi case (MRMC) comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "type of ground truth used", "sample size for the training set", and "how the ground truth for the training set was established" are not applicable to this document. These questions are typically relevant for discussing studies related to the performance of AI/ML algorithms.

The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance specifications for regulatory clearance, rather than presenting a study with acceptance criteria in the manner requested for an AI/ML device.

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The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrosurgical electrodes used for these indications.

The Genesis is an instrument intended for use as a monopolar electrosurgical accessory. The device reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use. Genesis devices are intended for use with monopolar electrosurgical accessories and will be packaged separately. Genesis instruments will also fit in currently marketed electrosurgical pencils offered by other manufacturers.

This document is a 510(k) summary for a medical device called "Genesis" from MEDISISS. It details the device's classification, indications for use, and a comparison to predicate devices, but lacks the specific performance data needed to populate all sections of your request.

Here's what can be extracted from the provided text, and where information is not available:

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

According to the provided text, the Genesis device is an electrosurgical accessory. The acceptance criteria and reported device performance would typically include quantifiable metrics related to its stated features: "reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use."

However, this document does not contain a table of acceptance criteria or reported device performance with specific numerical values for these claims. The 510(k) summary itself focuses on establishing substantial equivalence to predicate devices, not on providing detailed performance metrics.

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

Not available in the provided text. The document describes the device and its indications but does not mention any specific studies, test sets, sample sizes, or data 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 available in the provided text. There is no mention of an expert panel or ground truth establishment.

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

Not available in the provided text. No adjudication method is described as no test set data is provided.

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. The Genesis is an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

Not applicable. The Genesis is an electrosurgical device, not an algorithm.

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

Not available/Applicable in the provided text. As this is an electrosurgical accessory, the "ground truth" would likely relate to the physical effects of its operation (e.g., smoke reduction, tissue damage, eschar accumulation), which would be assessed directly during testing, not established through expert consensus or pathology in the same way a diagnostic device would. However, the specific methods are not described.

8. The sample size for the training set

Not applicable. The Genesis is a physical electrosurgical device, not a machine learning model, so there is no "training set."

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

Not applicable. See point 8.

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The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.

The provided document is a 510(k) summary for the MediSISS Reprocessed Non-electric GI Biopsy Forceps. This type of document is for a medical device that processes existing devices, rather than a diagnostic AI device. As such, the specific criteria for AI model performance (like sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets) are not applicable.

Instead, the acceptance criteria and study information provided relate to the reprocessing of surgical instruments to ensure they are safe and effective for reuse, demonstrating substantial equivalence to new, unused predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each validation test (cleaning, sterilization, functional performance, packaging). However, it refers to "validation data" and "routine tests" which implies a sampling methodology was used in accordance with the listed standards.

Data provenance refers to the origin and history of data. In this context, it relates to the devices that were reprocessed and tested. The predicate devices are from manufacturers like Bard, Esco Precision, Inc., and Olympus. The MediSISS device itself is a reprocessed version of various OEM models (e.g., Bard 385, Microvasive 1537, Olympus FB-240U, Wilson-Cook SDE 2.5-230). The testing would have been conducted on these reprocessed devices, likely in a controlled laboratory or testing facility ("retrospective" in the sense that the original devices are already manufactured, but "prospective" in the sense that the reprocessing and validation are performed afterward).

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

This type of information (number and qualification of specific experts for ground truth) is typically not applicable to the validation of reprocessed surgical instruments. The "ground truth" here is adherence to established engineering, microbiological, and material science standards. These standards (e.g., ISO, AAMI, ASTM, USP) are developed and maintained by expert committees and are considered the "ground truth" for safe and effective reprocessing. Compliance with these standards is assessed through validated test methods, not by subjective expert consensus on 'cases'.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic image reading. For device reprocessing validation, objective measurements and adherence to performance specifications of the listed standards dictate acceptance or rejection.

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 a reprocessed surgical instrument, not an AI diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This refers to AI algorithm performance without human intervention, which is not relevant to a reprocessed surgical instrument.

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed non-electric GI biopsy forceps is defined by:

• Adherence to recognized industry standards: ANSI/AAMI/ISO 11737-1, AAMI TIR No. 12, ASTM D4164, ISO 11607, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993, ASTM F88, ASTM F1980, United States Pharmacopeia 24, ASTM F2096-02. These standards specify acceptable limits for microbial load, sterility, residual levels, functional performance, and packaging integrity.
• Substantial equivalence to legally marketed predicate devices: The "ground truth" for safety and effectiveness is benchmarked against new, unused predicate devices (Bard K912549, Esco Precision K900015, Olympus K955065). Validation data confirmed that the reprocessed devices perform equivalently to these new devices.

8. The Sample Size for the Training Set

Not applicable. This concept is relevant for AI models, not for traditional medical device reprocessing validation.

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

Not applicable, as there is no "training set" in the context of this device's validation.

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The SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel instruments. The instruments are used in general, pediatric, thoracic, gynecologic, urologic, and other open and endoscopic surgeries for the transection, dissection, and coagulation of tissue(s).

Reprocessed Ultrasonic Surgical Instruments consist of hand-manipulated devices, with or without rotation capability, with or without cutting ability.

The handpiece handles are connected to the distal end-effector by a narrow-diameter metal barrel or shaft. The distal end of the device consists of a scalpel with a variety of end configurations including Flat, Cutting, and Blunt or a combination of the same. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula or used to be used in open surgery. The end-effectors are usually operated by the handpiece handles. The handles may be designed to be suppressed and released to activate the instruments end-effector. Similarly the handle may incorporate a button or switch to activate the end-effectors.

The device's shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (by manipulating controls located on the handle.)

This document describes the regulatory clearance for reprocessed ultrasonic surgical instruments, not a study evaluating an AI device or a new medical device's performance. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness studies is not applicable.

The document discusses the substantial equivalence of reprocessed devices to legally marketed predicate devices. The "performance data" section focuses on validation of the reprocessing methods (cleaning, sterilization, packaging) and demonstrating that the reprocessed devices maintain their mechanical function.

Here's a breakdown of the relevant information from the provided text, and an explanation of why other requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Non-Applicability for other sections:

The document focuses on the regulatory clearance of reprocessed medical devices (ultrasonic surgical instruments), not the development or evaluation of a new diagnostic or therapeutic device, especially not one involving AI. Therefore, the traditional "acceptance criteria" and "study" framework relevant to a novel device's performance often includes metrics like sensitivity, specificity, AUC, etc., which are not present here.

• 2. Sample size used for the test set and data provenance: Not applicable. The document discusses process validations for cleaning, sterilization, and mechanical function, not a test set for diagnostic accuracy or clinical outcomes of a novel device. The "data" refers to validation reports from these processes.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to the effectiveness of the reprocessing steps (e.g., sterility, cleanliness, mechanical integrity), which are assessed through standardized validation protocols, not expert consensus on diagnostic images or clinical conditions.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" in the sense of a set of cases requiring adjudication for a diagnostic outcome.
• 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 document is about reprocessed surgical instruments, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm or AI component in the described device or its reprocessing validation.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the reprocessing validation, the "ground truth" is defined by the established standards and methods for assessing sterility, cleanliness, and mechanical function. For example, sterility is confirmed by microbiological tests according to established protocols, and mechanical integrity by predefined engineering tests. This is not 'expert consensus' on clinical data, pathology, or outcomes data in the usual sense for a diagnostic device.
• 8. The sample size for the training set: Not applicable. There is no AI model or "training set" involved.
• 9. How the ground truth for the training set was established: Not applicable.

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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 may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. 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.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.

The provided text describes a 510(k) premarket notification for reprocessed electrosurgical instruments. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific acceptance criteria as would be found for novel devices or AI/software as a medical device (SaMD).

Therefore, many of the requested categories for acceptance criteria and study details are not applicable (N/A) in this context, as the focus is on process validation and demonstrating that the reprocessed device performs identically to its original counterpart.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: The document mentions "Representative samples of reprocessed electrosurgical instruments underwent bench testing." However, a specific numerical sample size for the test set is not provided.
   • Data Provenance: The testing appears to be internal "bench testing" conducted by SISS Inc. (d.b.a. MediSISS) in the US, as part of their manufacturing and re-processing validation. It is prospective as it's part of a manufacturing validation process.

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

   • N/A. This type of study (demonstrating substantial equivalence for reprocessed medical devices) does not typically involve expert review for ground truth in the same way an AI/CADe system would. The ground truth here is derived from objective measurements against established specifications for electrosurgical instrument function, cleaning, and sterilization.

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

   • N/A. Adjudication methods are typically relevant for subjective assessments or discrepancy resolution in clinical trials or expert-labeled datasets. This premarket notification relies on objective bench testing and compliance with standards.

4. 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 is a reprocessed medical device, not an AI/CADe system. No human reader studies or AI assistance are involved.

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

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

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

   • The ground truth is based on objective performance specifications and compliance with recognized standards (e.g., ISO for sterilization and biocompatibility) for electrosurgical instruments, along with visual and mechanical factory acceptance testing. The "truth" is that the reprocessed device functions identically and safely (e.g., cleaned, sterile, biocompatible) to the original predicate device.

7. The sample size for the training set:

   • N/A. This device does not involve machine learning or AI, so there is no "training set." The reprocessing "process validation" itself is akin to a training phase in a manufacturing context, ensuring the process consistently yields acceptable products.

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

   • N/A. As there is no AI training set, this is not applicable. The "ground truth" for the reprocessing process validation was established by adherence to industry standards and internal quality control specifications for device functionality, cleanliness, and sterility, verified through scientific methodologies like sterilization validation protocols.

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