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The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare® System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, binolar, single use Wands.

This 510(k) summary for the ArthroCare System 12000 does not describe any acceptance criteria or a study that uses a quantitative test set to prove the device meets said criteria.

The document states:
"This Special 510(k) proposes a modification in the performance specifications and labeling for the ArthroCare System 12000, which was previously cleared in K071709 on August 7, 2007. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System 12000 remain the same as in the predicate cleared 510(k). The modified ArthroCare System 12000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."

This indicates that the submission is for a modification to an already cleared device, and the basis for clearance is substantial equivalence to a predicate device (K071709), rather than a new study demonstrating performance against specific acceptance criteria using a test set. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

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The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

This is a 510(k) premarket notification for a modification to an existing device, the ArthroCare® Topaz® ArthroWands®. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics for this modified device is not explicitly present in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, or effect size) for the modified device are not provided in this 510(k) summary. This document primarily asserts that the modified device remains substantially equivalent to its predicate.

However, the "Summary of Safety and Effectiveness" section implicitly refers to acceptance criteria by stating: "The modified ArthroCare Topaz ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

This implies that the "acceptance criteria" are met if the modifications:

• Do not substantially change the device.
• Do not significantly affect the safety.
• Do not significantly affect the efficacy.

The "reported device performance" is not quantified in this document, but rather relies on the performance of the predicate devices. The modifications are a change in performance specifications, materials, and labeling, but the "indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare Topaz ArthroWands remain the same as in the predicate cleared 510(k)s."

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective study) is described as this is a Special 510(k) for device modification, not a clinical trial evaluating a new device. The substantial equivalence argument relies on the predicate's established safety and efficacy.

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

Not applicable. No new ground truth establishment is described for a test set in this 510(k) summary.

4. Adjudication method

Not applicable. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission.

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

Not applicable. This device is an electrosurgical device, not an AI or algorithm-based system.

7. The type of ground truth used

Not applicable in the context of this 510(k) for device modification. The "ground truth" for the original predicate device's safety and efficacy would have been established through pre-market testing and clinical experience, but not detailed here.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable.

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The ArthroCare ENT Plasma Wands 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
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.

The provided text is a 510(k) premarket notification for a medical device (ArthroCare® ENT Plasma Wands) and does not describe a study that conducted testing with associated acceptance criteria. Instead, it describes a "Special 510(k)" submission for a material modification to a previously cleared device.

The key points from the text related to performance, acceptance criteria, and studies are:

• Substantial Equivalence: The document states that the modified ArthroCare ENT Plasma Wands are "substantially equivalent" to a predicate device (K033257). This is a regulatory pathway and not a performance study demonstrating new acceptance criteria.
• No new performance criteria: The submission explicitly states: "The indications for use, technology, principle of operation, dimensional specifications, performance specifications, labeling and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)."
• No new study presented: Because the performance specifications are stated to be the same, and the modification is primarily material, the document does not present a new study with acceptance criteria to demonstrate device performance. It relies on the substantial equivalence to the previously cleared device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this specific document, as those types of studies were not included in this Special 510(k) submission.

Summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance data from a new study. It asserts that the "performance specifications... remain the same as in the predicate cleared 510(k)" (K033257).

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

Not applicable. No new test set data is presented as part of this Special 510(k) submission.

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

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set is described.

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

No. The document does not describe an MRMC comparative effectiveness study.

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

Not applicable. This device is an electrosurgical wand; it is not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. No new study requiring ground truth is described.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical wand; there is no AI algorithm with a training set discussed.

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

Not applicable. There is no training set discussed.

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The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures. The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (ArthroCare System), focusing on its substantial equivalence to previously cleared predicate devices due to a modification in performance specifications and labeling.

The document discusses:

• General information about the submitter and device.
• The device's description (electrosurgical system with generator, wands, and cable).
• Intended uses.
• A statement of substantial equivalence to predicate devices (K020832 and K030954).
• A summary statement affirming the modifications do not significantly affect safety or efficacy.
• An FDA letter confirming the 510(k) clearance based on substantial equivalence.
• The Indications for Use statement.

There are no details about:

1. Acceptance criteria
2. Reported device performance values against acceptance criteria
3. Sample sizes for test sets or their data provenance
4. Number or qualifications of experts for ground truth
5. Adjudication methods
6. MRMC comparative effectiveness studies (or effect sizes)
7. Standalone algorithm performance studies
8. Type of ground truth used
9. Training set sample size
10. How ground truth for the training set was established

The document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed report of a performance study with specific acceptance criteria.

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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

The provided document, K030551, is a 510(k) Pre-market Notification for the ArthroCare ArthroWands. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics.

Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for the device itself (as if it were a novel device undergoing clinical efficacy trials) is not present in this document. The document primarily attests that the modifications to the ArthroWands do not significantly affect safety or efficacy compared to the previously cleared predicate device (K020557).

Here's an breakdown based on the available information:

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

This document does not contain a table of acceptance criteria or reported device performance in the way one would expect for a de novo submission or a clinical trial report. The "acceptance criteria" here is implicitly "substantial equivalence" to the predicate device. The performance is assessed through the unchanged indications for use and principle of operation.

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

This information is not provided in the document. As a 510(k) for modifications to a predicate device, it likely relies on non-clinical testing (e.g., bench testing for dimensional changes, material compatibility) and a comparison to the established safety and efficacy of the predicate device, rather than a clinical "test set" in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The document does not describe a clinical study requiring ground truth established by experts.

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

This information is not applicable/not provided. There is no description of a clinical test set 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

This information is not applicable/not provided. This device is an electrosurgical tool, not an AI-powered diagnostic imaging device.

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

This information is not applicable/not provided. This is an electrosurgical device, not an algorithm.

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

This information is not applicable/not provided. The assessment relies on substantial equivalence to the predicate device, which would have had its own methods of demonstrating safety and effectiveness originally (likely through a combination of non-clinical and potentially some clinical data, but not detailed here).

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe a machine learning algorithm requiring a training set.

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

This information is not applicable/not provided. No training set is mentioned as this device is not an AI/ML product.

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The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.

The provided document is a 510(k) Summary for the ArthroCare Electrosurgery Wands, which details a modification in material for an already cleared device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria for device performance.

Therefore, the information typically requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this specific submission.

The document states:
"The proposed modification in material is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices." (page 1)

And confirms:
"The indications for use, technology, principle of operation, design, performance and dimensional specifications, labeling, packaging, and sterilization parameters of the ArthroCare Electrosurgery Wands remain the same as in the predicate cleared 510(k)." (page 1)

This means that the device's performance characteristics (and any associated acceptance criteria) were established and accepted during the clearance of the predicate device (K020622). This 510(k) is specifically for a material change, not a new device requiring new performance data.

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The ArthroCare Timer is an accessory, supplied separately, that can be used with the Electrosurgery System in the following indications:

• The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
  Arthroscopic and Orthopedic Procedures: Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
  Ablation and Debridement: ACL/PCL (Knee), Acromioplasty (Shoulder), Articular Cartilage (All Joints), Bursectomy (All Joints), Chondroplasty (All Joints), Facia (All Joints), Ligament (All Joints), Notchplasty (Knee), Scar Tissue (All Joints), Soft Tissue (All Joints), Subacromial Decompression (Shoulder), Synovectomy (All Joints), Tendon (All Joints)
  Excision and Resection: Acetabular Labrum (Hip), Articular Labrum (All Joints), Capsule (All Joints), Capsular Release (Knee), Cartilage Flaps (Knee), Cysts (All Joints), Discoid Meniscus (Knee), Frozen Shoulder Release (Shoulder), Glenoidale Labrum (Shoulder), Lateral Release (Knee), Ligament (All Joints), Loose Bodies (All Joints), Meniscal Cystectomy (Knee), Meniscectomy (Knee), Plica Removal (All Joints), Scar Tissue (All Joints), Soft Tissue (All Joints), Synovial Membrane (All Joints), Tendon (All Joints), Triangular Fibrocartilage (TFCC) (Wrist), Villusectomy (Knee)
  Coagulation: ACL/PCL (Knee), Articular Cartilage (All Joints), Carpal Ligaments (Wrist), Glenohumeral Capsule (Shoulder), Ligament (All Joints), Medial Retinaculum (Knee), Rotator Cuff (Shoulder), Tendon (All Joints), Wrist Tendons (Wrist)

The ArthroCare Timer is an accessory that can be used with ArthroCare's Electrosurgery System. It is designed to control the duration of therapy treatment during soft tissue ablation procedures.

The provided document is a 510(k) Summary for the ArthroCare® Timer, an accessory to an electrosurgery system. This submission modifies the performance specifications and labeling for an already cleared electrosurgery system.

Crucially, the document explicitly states: "The proposed addition of the ArthroCare Timer performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."

Therefore, this submission does not contain a new study proving the device meets acceptance criteria. Instead, it leverages the fact that the changes are deemed non-substantial and rely on the prior clearance of the predicate device (K020557 ArthroCare® ArthroWands). The acceptance criteria for the Timer accessory itself would likely be related to its function of timing, which would be tested internally against its design specifications rather than requiring a clinical study with patients or experts.

Given this, I cannot provide the information requested in your numbered points because a new study to prove the device meets acceptance criteria as typically understood for new medical devices (i.e., clinical trials, AI performance studies) was not conducted or reported in this 510(k) summary.

The document is primarily a regulatory filing asserting substantial equivalence based on the minor nature of the modification.

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ArthroCare System 2000: The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
ArthroCare Orthopedic Electrosurgery System: The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
ArthroCare Bipolar Loop: The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in neurosurgical, spinal, and urological procedures.

The provided 510(k) summary for the ArthroCare System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a communication from ArthroCare Corporation to the FDA seeking substantial equivalence for modifications to existing devices (ArthroCare Wands). It primarily focuses on:

• Device Description and Intended Use: Outlining what the devices are and what procedures they are used for.
• Predicate Device: Identifying the previously cleared device (K011634) to which the current submission claims substantial equivalence.
• Modifications: Stating that the proposed modifications are in "materials and labeling" and do not affect the safety or efficacy, or the core technology, principle of operation, performance, or dimensional specifications.
• Substantial Equivalence Claim: Asserting that the modified Wands are substantially equivalent to the predicate devices.
• FDA Response: The FDA letter confirms the substantial equivalence determination based on the provided information.

There is no mention of:

1. Acceptance Criteria Table: No such table is presented.
2. Reported Device Performance: No specific performance metrics or data derived from testing are included.
3. Sample Size/Data Provenance: No information about test sets, sample sizes, or data origin is provided.
4. Ground Truth Experts/Qualification: No details about experts, their qualifications, or how ground truth was established.
5. Adjudication Method: No adjudication process is described.
6. MRMC Comparative Effectiveness Study: No such study is mentioned, nor any effect size.
7. Standalone Performance: No algorithm-only performance is discussed, as this is a medical device, not an AI algorithm.
8. Type of Ground Truth: No ground truth type is specified because no performance study is detailed.
9. Training Set Sample Size: No training set is mentioned as this is not an AI/ML device.
10. Training Set Ground Truth Establishment: Not applicable.

This document is a regulatory submission for device modifications based on a claim of substantial equivalence to a predicate device, not a performance study report with acceptance criteria. The claim is that the modifications do not significantly affect the safety or efficacy, implying that the performance assumed for the predicate device still holds without a new performance study being explicitly detailed in this document.

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The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Wands are bipolar, single use, high frequency electrosurgical devices.

This document describes a Special 510(k) submission for the ArthroCare Perc-D SpineWand, proposing modifications in dimensional and performance limits, materials, and labeling. The submission asserts that these changes are not substantial and do not significantly affect safety or efficacy. Therefore, a comprehensive study to establish new acceptance criteria and prove device performance against them, as if it were a novel device, was not conducted or required. The information provided focuses on demonstrating substantial equivalence to a previously cleared device.

Here's an analysis based on the provided text, addressing the requested points:

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

Based on the provided text, no specific quantitative acceptance criteria or objective performance metrics are reported for the modified Perc-D SpineWand. The submission is a "Special 510(k)" which indicates that the changes are minor and primarily relate to dimensional and performance limits, materials, and labeling, asserting that these do not significantly affect safety or efficacy. The "Substantial Equivalence" section states: "The modified Perc-D Wands, as described in this submission, are substantially equivalent to the predicate device...The proposed modification in dimensional and to the producer, specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, no direct table of acceptance criteria and associated performance results is available in this document. The "acceptance criteria" here are implicitly met by demonstrating that the modifications do not alter the fundamental safety and effectiveness profile established for the predicate device.

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

No new test set or clinical data is mentioned for this Special 510(k) submission. The submission relies on the substantial equivalence to the predicate device (K010811), which was cleared on May 30, 2001.

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. No new test set or clinical data requiring expert ground truth establishment for a diagnostic or AI device is described.

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

Not applicable. No new test set or clinical data requiring adjudication is 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

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is an electrosurgical device, not an algorithm.

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

Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for the device's efficacy and safety would have been established during the clearance of the predicate device (K010811) through appropriate non-clinical testing and potentially clinical data, as required for that submission.

8. The sample size for the training set

Not applicable. This device is an electrosurgical tool and does not involve AI/machine learning models requiring a training set.

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

Not applicable. See point 8.

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The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.

The provided document is a 510(k) summary for ArthroCare Electrosurgery Wands. It discusses a special 510(k) submission for modifications to a previously cleared device (K014222). The key aspect of this submission is that the modified specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices, and thus the device is considered substantially equivalent to its predicate.

Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, such as sensitivity, specificity, or accuracy metrics often associated with AI/ML devices.

This document is a regulatory submission for an electrosurgical device, not an AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the information contained within this 510(k) summary.

The summary states: "The Electrosurgery System modified Wands, as described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in dimensional and performance specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices." This statement serves as the "proof" that the device meets acceptance criteria, implying that it continues to perform as safely and effectively as the predicate device because the changes are not substantial.

Therefore, I cannot populate the table or answer most of the questions as the document does not provide this type of information.

Here's what I can infer from the document regarding the general nature of this submission:

1. A table of acceptance criteria and the reported device performance:
   The document asserts "substantial equivalence" to a predicate device (K014222) due to "modifications in dimensional and performance specifications, materials, and labeling [that] are not substantial and do not significantly affect the safety or efficacy of the devices." This implies that the 'acceptance criteria' are met by demonstrating that the modified device performs identically or insignificantly differently from the predicate device, whose performance would have been established during its original clearance. No specific quantitative performance metrics (e.g., in terms of cutting efficiency, coagulation time, tissue damage) or acceptance thresholds for these metrics are provided in this summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. This document does not describe a clinical study in the context of an AI/ML device to establish performance metrics against a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method 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.

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: Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory clearance document for an electrosurgical device based on substantial equivalence, not a performance study report for an AI/ML medical device.

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