The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed DePuy Mitek Ablation Wand. It does not contain information about an AI/machine learning device, nor does it provide the detailed specifics about acceptance criteria involving performance metrics like accuracy, sensitivity, or specificity, or the methodology for a multi-reader multi-case (MRMC) study.

The document discusses the substantial equivalence of the reprocessed device to its original (OEM) predicate devices based on various performance tests conducted to ensure that the reprocessing activities did not affect the form or function of the device and that it performs as well as the original, new device.

Therefore, many of the requested details about acceptance criteria and study methodology for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.

However, I can extract the acceptance criteria and performance data for this reprocessed medical device as presented in the document:

Acceptance Criteria and Device Performance for Reprocessed DePuy Mitek Ablation Wand

The acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs equivalently to the original, new device in various tests. The study's goal was to prove substantial equivalence, meaning the reprocessed device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates "side by side" testing with predicate devices. Specific sample sizes for each test are not provided. The data provenance is presumed to be from the manufacturer's internal testing facilities, as is typical for 510(k) submissions, but a specific country of origin for the data generation or whether it was retrospective/prospective is not mentioned. Given the nature of benchtop testing, it would be prospective.

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

Not applicable. The "ground truth" for this reprocessed device relates to its physical, functional, and electrical performance compared to a new, predicate device, not to diagnostic interpretation requiring expert consensus. Performance is measured against engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable. Performance testing for this device does not involve human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a reprocessed medical device, not an AI/machine learning diagnostic aid.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is measured directly through benchtop tests.

7. The type of ground truth used

The "ground truth" for this device is based on engineering specifications, established performance standards, and comparison to the performance of the new, predicate device. For cleaning, it refers to the absence of residues. For functional performance, it's the measured performance (e.g., thermal effects, bending, drop) being equivalent to the predicate. For biocompatibility, it's meeting ISO standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The Reprocessed ArthroCare Ablation Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Reprocessed ArthroCare Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.

This document is a 510(k) summary for a reprocessed medical device, specifically "Reprocessed ArthroCare Ablation Wands." It does not contain information about an AI/ML-driven device or study that uses acceptance criteria in the typical sense of measuring algorithm performance against ground truth in a clinical or diagnostic context.

Instead, the "acceptance criteria" and "study" mentioned here refer to the validation of the reprocessing process to demonstrate that the reprocessed device is substantially equivalent to the original, new device. The "performance" being reported is related to the physical and functional integrity of the reprocessed wands.

Therefore, many of the requested fields are not applicable in this context (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) because this is not an AI/ML device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each type of benchtop performance test (e.g., how many wands were subjected to thermal effects testing, how many for bending, etc.). It generally refers to "the subject devices" and "predicate devices" being tested.
• Data Provenance: The data is from benchtop performance testing conducted by ReNovo, Inc. (the submitter), comparing their reprocessed devices against the predicate (OEM) devices. This is prospective testing for the 510(k) submission. No country of origin is explicitly stated for the "data," but the submitter is based in Bend, OR, USA.

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 an AI/ML device, and "ground truth" in the diagnostic context is not relevant here. The "ground truth" for these tests are objective, measurable physical and chemical properties and functional performance characteristics, often against established industry standards. These are not established by human experts in a subjective manner.

4. Adjudication method for the test set:

• Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring expert adjudication. Performance is measured against predefined, objective pass/fail criteria or equivalence to a predicate device.

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 not an AI/ML device. No human-in-the-loop studies or MRMC studies were performed.

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

• Not Applicable. This is not an AI/ML device. There is no algorithm.

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

• The "ground truth" here is the established physical, chemical, and functional performance characteristics of the original, new (predicate) medical device and compliance with relevant engineering and biocompatibility standards (e.g., ISO 10993, IEC 60601). The "ground truth" for cleaning effectively would be specific limits on residual protein/carbohydrates, for example. For functional performance, it would be the performance of the new device.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. No training set was used.

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

• Not Applicable. This is not an AI/ML device. No training set was used.

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The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures,
• Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy (including palatine tonsils)
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Reprocessed ENT Coblators are radiofrequency (RF) surgical devices which are powered by an RF generator. The device is designed for the hemostasis of blood vessels, dissection, and removal of tissue during otorhinolaryngology ( ENT) surgical procedures.

ENT probes vary in their configuration depending on intended usage in their diameter, length, electrode shape, and saline delivery/suction capabilities. The materials of constructions are generally polycarbonate handles, stainless steel shafts, Polyester or Tygon insulation material, tungsten electrodes, alumina ceramic tips and PVC saline delivery/suction tubing lines

The provided text describes the 510(k) summary for the device "Reprocessed ArthroCare ENT Coblator." This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a totally new device meets acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, performance against those criteria, and the specifics of a study proving device performance (like sample size for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable in the context of this 510(k) submission.

The core of this submission is to show that the reprocessed device performs as safely and effectively as the original (OEM) device, with specific testing around the reprocessing procedure and material changes.

Here's an analysis based on the provided text:

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

The document doesn't provide a quantitative table of acceptance criteria with specific thresholds and device performance metrics in the way one would expect for a novel device's clinical trial. Instead, it outlines the types of performance tests conducted to demonstrate equivalence to the predicate devices. The acceptance criterion for these tests is that the reprocessed device performs equivalently to the OEM device.

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: The document does not specify the exact sample sizes (number of units) used for each type of benchtop performance testing. It generally refers to "the subject devices" and "the reprocessed devices" in comparison to "an identical new OEM device," implying a comparative study design.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given the submission is to the FDA (USA), it's highly probable the testing was conducted in the US or at a facility recognized by US standards. The testing described is prospective in nature, as it involves newly reprocessed devices undergoing specific tests.

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

• Not Applicable. This type of information (number and qualification of experts for ground truth) is relevant for clinical studies involving human interpretation (e.g., radiology AI). For a reprocessed electrosurgical device, "ground truth" is established by direct physical, chemical, and electrical measurements against established engineering and safety standards, or direct comparison to the OEM device. Experts involved would be engineers, chemists, and microbiologists in the respective testing fields, but their roles are not for "establishing ground truth" in the diagnostic sense.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret medical images or data and a consensus is needed. In benchtop testing of a reprocessed medical device, the results are typically quantitative measurements or pass/fail criteria based on objective standards, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is relevant for diagnostic devices, particularly those involving AI or image interpretation by human readers. This device is an electrosurgical cutting and coagulation device, not a diagnostic imaging device. Its performance is assessed through benchtop and lab testing, not through human reader interpretation of images.

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

• Not Applicable. This device does not contain an algorithm or software. The document explicitly states under "Software Verification and Validation Testing": "Software Testing is not applicable, because the device does not contain software."

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

• For this device, the "ground truth" (or more accurately, the reference standard) is the performance of the new, original equipment manufacturer (OEM) device and adherence to established international and national standards for medical device safety and performance (e.g., IEC 60601 for electrical safety, biocompatibility standards, and internal specifications for functional performance like thermal effects). The goal is to demonstrate that the reprocessed device is "as good as" the original and meets all relevant safety requirements.

8. The sample size for the training set:

• Not Applicable. This refers to machine learning models. The Reprocessed ArthroCare ENT Coblator is a physical medical device, not an AI/ML algorithm, so there is no training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence of a reprocessed physical medical device to its predicate. The type of testing and "acceptance criteria" presented are geared towards proving that the reprocessing does not compromise the device's safety and effectiveness compared to the original, rather than establishing efficacy for a novel diagnostic or AI-driven device.

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The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.

The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

The provided document is a 510(k) summary for a reprocessed medical device, specifically Reprocessed Ethicon Bladeless Trocars and Universal Trocar Sleeves. It does not describe an AI/ML-based device or a diagnostic algorithm, but rather a physical medical device that is reprocessed for reuse.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and training/test set data, which are typical for AI/ML-based diagnostic devices, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the new Ethicon trocar) through:

1. Comparison of Technological Characteristics: Indications for Use, Materials, Design, Energy Source.
2. Performance Testing: Benchtop functional tests (Seal Drag, Seal Leakage, Insertion, Fixation, Removal Force Test), Product Stability (Shelf Life Testing), Cleaning Validation (Residual Protein and Hemoglobin, Visual Inspection, Cleaning Performance Qualification), Sterilization and Packaging (EtO Sterilization Testing, Simulated Shipment Testing), and Biocompatibility Testing.

The "acceptance criteria" for this device are that its performance, once reprocessed, is equivalent to that of a new, original equipment manufacturer (OEM) device. The study proving this involves side-by-side benchtop testing and cleaning validation.

To directly answer your prompt's questions based on the provided document, where applicable:

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

The document describes the types of tests performed and the overarching goal of demonstrating "substantial equivalence" to the OEM device. It doesn't provide specific numerical acceptance criteria (e.g., "Seal Drag

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The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

This document describes the premarket notification for a Reprocessed Covidien Trocar (K172093). The study contained within this document evaluates the performance of the reprocessed device compared to the original equipment manufacturer (OEM) device.

Here's an analysis of the provided information according to your criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, the performance testing aims to demonstrate equivalence to the new OEM device. Therefore, the "acceptance criteria" here implicitly means "performance equivalent to the new OEM device."

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

• Sample Size: The document does not specify the exact sample size for the "test set" (i.e., how many reprocessed trocars were tested against how many new OEM trocars for each performance test). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed.
• Data Provenance: The data is based on benchtop performance testing conducted by ReNovo, Inc. It is prospective testing designed to demonstrate the performance of their reprocessed devices. The country of origin of the data is not explicitly stated but is implied to be where ReNovo, Inc. conducted its testing (USA).

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

Not applicable. This study does not involve human readers or interpretation of medical images/data where expert ground truth establishment would be required. The evaluation is based on objective physical and chemical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation or consensus. The performance tests are objective laboratory 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 study on the reprocessing of a physical medical device (trocar), not an AI imaging or diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed device itself, which was evaluated through benchtop testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is essentially the performance and characteristics of a new, legally marketed OEM Covidien Trocar. The reprocessed device's performance is compared against this established benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set" in this context. The study focuses on evaluating the reprocessing process and the final reprocessed product.

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

Not applicable, as there is no training set for this type of device evaluation.

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The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.

The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power II Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
Shoulder
Ankle
Elbow
Wrist
Hip
Temporamandibular

The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone. Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.

The Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic surgical techniques. Shavers have sharp rotating inner blades housed in an outer shaft designed to cut tissue. Burs have an abrasive wearing surface that rotate in an outer sheath to grind down bone. The housing has a window cut out on one side of the distal end, allowing the bur to cut one part of the intended anatomy, while the adjacent one is still protected by the housing on the opposite side of the abrader, bur or blade. There are various configurations of diameter, length, and cutting or grinding surfaces. The materials of construction are generally: metal shafts, lubricants (between the inner and outer components to reduce friction and heat), and polymer hubs bonded to the shafts. The polymer hub connects to a user-supplied motorized hand piece, which drives the internal abrader, bur or blade inside the outer housing. The handpiece provides suction to remove tissue which has been cut during the surgical procedure.

There are 39 Stryker shavers and 33 Stryker burs included in this submission. The Stryker shavers and burs are used with the Total Performance System Shaver handpiece is made of a motor housing with a coupling mechanism to secure the shavers/burs to the handpiece.

There are 31 Smith & Nephew shavers and 32 Smith & Nephew burs included in this submission. The Smith & Nephew shavers and burs are intended to be used with the Smith & Nephew DYONICS Power II Shaver System control unit. This system is compatible with DYONICS POWER handpieces.

There are 94 ConMed/Linvatec shavers and 26 ConMed/Linvatec burs included in this submission. The Linvatec shavers and burs are intended to be used with the Linvatec Integrated Drive/Pump system. The system has three different handpieces that ca be used for otolaryngology, neurological surgical, orthopedic, and spinal procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided text, extracting what is available and noting what is not mentioned.

Acceptance Criteria and Study Information for Reprocessed Shavers/Burs

Note: The provided document is a 510(k) summary for ReNovo, Inc.'s Reprocessed Shavers/Burs. It focuses on demonstrating substantial equivalence to predicate devices, which means proving the reprocessed devices perform as safely and effectively as new OEM devices. Therefore, the "acceptance criteria" here refer to the performance benchmarks set against the new OEM devices, and the "study" is the comparison testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set used for performance testing (e.g., how many reprocessed shavers/burs of each type were tested). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed, and this testing was done "after three reprocessing cycles."
• Data Provenance: The data comes from benchtop performance testing conducted by ReNovo, Inc. (the submitter). The country of origin for the data is USA. The study is not retrospective or prospective in the clinical sense, as it is a benchtop comparison study, not a study involving patient data.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth for Test Set: This is not applicable in the context of this 510(k) summary. The "ground truth" for these reprocessed medical devices is their performance equivalence to new OEM devices. There are no "experts" establishing a "ground truth" for patient-specific data or diagnostic interpretations. The assessment is based on quantifiable engineering and biological performance metrics compared against the predicate device.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The tests performed are objective, quantitative measurements (e.g., sharpness, bending properties, chemical residue levels, sterility). There is no subjective interpretation requiring an adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems involving human readers and clinical cases, not for the performance validation of reprocessed surgical instruments.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone performance study (algorithm only) was not done. This is not an AI/algorithm-driven device. The "device" here refers to the physical reprocessed surgical instruments.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is the performance of new, original equipment manufacturer (OEM) devices. The reprocessed devices are compared directly against these new OEM devices across various functional, cleaning, and material characteristics to establish substantial equivalence.

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. This document describes the validation of reprocessed physical medical devices, not an AI or machine learning model that would require a training set.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for these devices.

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