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The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.

Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode. The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.

This document is a 510(k) premarket notification for a medical device, the "Single Use Arthroscopic Electrode (with Pencil)". It aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this regulatory submission.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information and a notation for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a formal table of explicit acceptance criteria with quantitative targets and corresponding reported device performance. The performance testing section describes comparative testing between the subject device and the predicate device, aiming to show "substantially equivalent" thermal effect and tissue stickiness.

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

• Sample Size for performance testing: Not specified. The document states "comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon". The number of samples for each tissue type or total samples is not provided.
• Data Provenance: The performance testing involved animal models (porcine tissue and bovine tendon). The country of origin of the data is not specified, but the manufacturing company is based in Hong Kong. The testing is retrospective in the sense that it was conducted as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.

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

This information is not provided. The performance testing involved objective measurements of thermal effect and tissue stickiness rather than subjective expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving subjective assessments (e.g., image interpretation), which is not the nature of the performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of AI in assisting human readers, which is not relevant for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical electrosurgical electrode, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" was implicitly derived from direct observation and measurement of the biophysical effects (thermal effect and tissue stickiness) on the animal tissues under controlled experimental conditions. For sterility, packaging, electrical safety, and biocompatibility, the ground truth was established by adherence to and passing of specified international standards (ISO, IEC).

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense.

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

This information is not applicable/not provided for the same reason as point 8.

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The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure

The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post.
The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop.
The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient.
The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm.
This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.

Based on the provided text, the device in question is a "Single Use Micro Electrode" used for electrosurgical cutting and coagulation. However, the document is a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices.

This document describes a device that is compared to predicate devices based on technological characteristics and performance testing data to establish substantial equivalence. It does NOT describe a study evaluating the performance of an AI/ML powered device, nor does it lay out explicit "acceptance criteria" in the sense of performance metrics typically used for AI/ML models (e.g., sensitivity, specificity, AUC).

Therefore, I cannot extract the information required by your prompt, as the prompt's questions are geared towards the evaluation of an AI-powered diagnostic or similar system, which is not what this document pertains to.

The document discusses:

• Performance Testing Data: "Operation Tests include comparative testing was performed on porcine tissue: kidney, liver, and muscle for both Cut mode and Coagulation mode. It demonstrates that the thermal effect and tissue stickiness on the tip of electrode are no significant difference between proposed device and predicate device."
• Safety and Biocompatibility testing data: Compliance with electrical safety standards (IEC60601-1, IEC60601-2-2) and biological tests (Intracutaneous Reactivity, In vitro Cytotoxicity, Skin sensitization) showing "No biological effect resulted."

These are typical tests for electrosurgical devices to prove safety and efficacy, not AI/ML model performance.

To directly answer your request based on the absence of the information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses comparative testing results, noting "no significant difference" in thermal effect and tissue stickiness compared to predicate devices, and that safety tests showed "no biological effect." There are no quantitative acceptance criteria (like sensitivity/specificity targets) for an AI/ML model.
2. Sample sized used for the test set and the data provenance:
   • Sample Size: Not specified for the "operation tests." It mentions "porcine tissue: kidney, liver, and muscle" but not the number of samples or animals.
   • Data Provenance: Porcine tissue (animal study). No country of origin is specified for the tissue or the tests themselves, only that the company is located in Hong Kong, China.
   • Retrospective or Prospective: The "operation tests" would be prospective as they were performed specifically for this submission.
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 study requiring expert ground truth for imaging or diagnostic interpretation. The evaluation seems to be based on physical properties (thermal effect, tissue stickiness) and biological reactions.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Not an AI/ML study.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claims appears to be based on direct measurable effects (thermal effect, tissue stickiness) and standard biological safety assays.
8. The sample size for the training set: Not applicable. There is no AI/ML model involved, hence no training set.
9. How the ground truth for the training set was established: Not applicable. No training set.

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The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.

The provided document, a 510(k) summary for the "Disposable General Electrode" (K152059), primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining acceptance criteria and device performance in the manner typically associated with clinical trials of AI/diagnostic devices.

Therefore, many of the requested fields cannot be directly answered from the given document as it describes a conventional medical device (electrosurgical electrode) and its safety and performance through comparison to a predicate device, rather than an AI-powered diagnostic tool. The document does not feature a typical AI/diagnostic device study with acceptance criteria, ground truth, expert review, sample sizes for training/test sets, or comparative effectiveness with human readers.

However, I will extract the information that is present and indicate where the information is not applicable or not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)
• IEC60601-2-2: 2009 (Fifth Ed) |
  | Compliance with these standards is the implicit acceptance criterion. | The device's safety testing was performed to comply with these standards. (Assumed compliance, as it's a 510(k) submission). |
  | Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) Residue | EO and ECH residue test performed in accordance with ISO10993-7. |
  | EO residue ≤ 4 mg per device
  ECH residue ≤ 10 mg per device | The residue level on the patient contact portion of the device shall be met below standard (interpreted as compliance was achieved). |
  | Biocompatibility (ISO 10993-1) | Biological evaluation performed in accordance with ISO10993-1. |
  | Specific acceptance criteria for biocompatibility tests are not stated, but compliance with the standard and passing the tests below are implied acceptance criteria. | Verified that the material use of the proposed electrode is biocompatible with intended use, through:
• Intracutaneous Reactivity Test
• In vitro Cytotoxicity Test
• Skin sensitization tests |

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

• Sample Size for Test Set: The document mentions "comparative testing was performed on porcine kidney, liver, and muscle." The number of porcine samples or tests performed is not specified.
• Data Provenance: The data is from laboratory testing performed using animal tissues (porcine kidney, liver, and muscle). The country of origin of the data is not explicitly stated, but the manufacturer is based in Hong Kong, China. The testing described is prospective, as it was conducted specifically for this submission.

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

This is Not Applicable as the device is an electrosurgical electrode, not a diagnostic device requiring expert interpretation for ground truth. The performance is assessed through objective measurements (cutting/coagulation effectiveness, eschar buildup, residue levels, biological reactions) and compliance with engineering standards.

4. Adjudication method for the test set

This is Not Applicable. Performance was assessed through direct measurements and comparison to a predicate device, not through subjective expert 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 is Not Applicable. This is a conventional medical device, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

This is Not Applicable. The device is an electrosurgical electrode and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:

• Objective performance comparison: "No significant difference" in operation result and eschar buildup compared to the predicate device on animal tissue (porcine kidney, liver, and muscle).
• Compliance with international standards: Adherence to IEC 60601-1, IEC 60601-2-2, ISO 10993-7, and ISO 10993-1.
• Chemical and biological tests: Measured EO/ECH residue levels and positive outcomes from intracutaneous reactivity, in vitro cytotoxicity, and skin sensitization tests.

8. The sample size for the training set

This is Not Applicable. This is not an AI/machine learning device, so there is no training set.

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

This is Not Applicable, as there is no training set for an AI/machine learning device.

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The electrode is used to cut and coagulate the selected tissue for laparoscopic procedures.

Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.

This document describes a 510(k) premarket notification for a Disposable Laparoscopic Electrode. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove that the device meets specific acceptance criteria in the way a clinical study would for efficacy. Therefore, much of the requested information regarding clinical study parameters (sample size, ground truth, experts, MRMC studies, etc.) is not applicable to this type of submission.

However, based on the provided text, I can extract information related to performance testing to support the claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study, but rather describes a comparative performance test to show equivalence. The "acceptance" is implied by demonstrating "no significant difference" to the predicate device.

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

• Sample Size: Not explicitly stated as a number of "samples" in the context of a clinical trial. The comparative testing was performed on "porcine kidney, liver, and muscle." The number of animal units or tests conducted on these tissues is not provided.
• Data Provenance: Porcine (animal) tissue. The study is a prospective experimental study in a laboratory setting, not a retrospective or prospective human clinical data study.

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

• This is not applicable to the type of performance testing described. The "ground truth" was established by direct observation and measurement of physical effects (cutting, coagulation, eschar buildup) in the laboratory setting. There were no human "experts" establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was a comparative experimental study, not a study requiring adjudication of expert interpretations.

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 medical device for surgical procedures, not an AI/imaging device requiring human reader assessment.

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

• Not applicable. This is a medical device for surgical procedures, not an algorithm.

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

• The "ground truth" for the performance testing was the direct physical effect observed on biological tissue (porcine kidney, liver, and muscle) during cutting and coagulation, and the qualitative assessment of eschar buildup. For safety and biocompatibility, the ground truth was meeting established international standards (IEC and ISO).

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable.

Summary of the Study:

The study was a comparative performance testing conducted in a laboratory setting using porcine tissues. The goal was to demonstrate that the Disposable Laparoscopic Electrode performed "no significant difference" compared to an existing predicate device (Megadyne E-Z Clean Disposable Laparoscopic Electrodes and Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable) in terms of cutting, coagulation, and eschar buildup across various power settings (30W, 50W, 100W). Additionally, the device underwent testing to ensure electrical safety (IEC standards) and biocompatibility (ISO standards), indicating compliance with these predefined safety "acceptance criteria." The specific quantitative results of the comparative tissue tests were not detailed, but the conclusion states "no significant difference."

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