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The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The ShinEvac® Smoke Evacuation Pencil, model: SW12200-APBCSE36, SW12200-APBCSE36G, SW12200-APBCSE56, SW12200-APBCSE56G, SW12200-APBCSB36 and SW12200-APBCSB56 is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Electro surgical Pencil is one of accessories of HF Electro Surgical Unit generates frequency from 300~600KHz for coagulation and cutting function, power up to 80W and 120W respectively. It is connected with cable conducting electro energy from unit and is holding a detachable tip electrode for the electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. This device can remove surgical smoke when connected to a smoke evacuator.

The provided text describes a medical device, the ShinEvac® Smoke Evacuation Pencil, seeking FDA clearance via a 510(k) submission. This type of submission generally demonstrates substantial equivalence to a predicate device rather than providing extensive de novo clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the study described here focuses on demonstrating that the new device performs similarly to a legally marketed predicate device, especially regarding safety and functional aspects, rather than setting and meeting specific quantitative clinical performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices.

However, I can extract information related to performance testing and safety, which serve as the acceptance criteria for this type of device within the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Performance Testing (Animal Study): The animal study involved evaluating the device in "three different tissues" ("liver, kidney and muscle"). The exact number of animals or trials within each tissue type is not specified.
• Data Provenance: The animal study is prospective (conducted for the purpose of this submission). The country of origin for the animal study is not specified in the provided text.
• Other tests (Safety, Biocompatibility, Sterilization): These are typically laboratory-based tests conducted on device samples. The specific sample sizes for these tests are not provided but would be defined by the respective international standards (e.g., ISO, IEC).

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

• This device is an electrosurgical pencil, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance metrics (like sensitivity/specificity).
• For the animal study, the evaluation of "safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage" would likely involve veterinary pathologists or researchers with expertise in electrosurgery and tissue histopathology. However, the exact number and qualifications of these experts are not specified in the document.
• For the other tests (safety, biocompatibility, sterilization), the "ground truth" is established by adherence to the objective criteria and protocols defined in the referenced international standards.

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

• Not applicable as this is not a diagnostic AI device requiring expert consensus for ground truth labeling. Performance is assessed against objective engineering and biological standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an electrosurgical pencil. The submission is for a physical medical device, not an AI algorithm assisting human readers.

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

• Not applicable. This device is a physical electrosurgical tool and not an AI algorithm.

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

• For the animal study, the "ground truth" for assessing cutting performance, tissue temperature, cooling time, and thermal damage is established through direct observation, measurement, and potentially pathological examination of a histologist or other experts.
• For safety, biocompatibility, and sterilization tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies stipulated within the referenced IEC and ISO international standards. Compliance with these standards serves as the benchmark.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. This device is not an AI algorithm that requires a training set.

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The Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

SHINMED model SW-988 Ultrasonic Nebulizer

I am sorry, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device (SHINMED Model SW-988 Ultrasonic Nebulizer). This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain the detailed technical information required to answer your questions about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or in accompanying clinical/technical reports, which are not part of the provided text.

Therefore, I cannot provide the requested information based solely on the given input.

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The Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Shinmed Various Model: of reusable Electro-Surgical Pencils, SW11100, SW11200, SW11202, SW11300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The cevice is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The SHINMED Various Models of Electro-Surgical Pencils used with a 510k-clearance generator are intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Not Found

The provided text is a 510(k) summary for SHINMED electrosurgical pencils. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. However, it does not contain specific acceptance criteria, details of a performance study, or reported device performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML-driven medical device.

Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly extracted from this document because it describes a traditional electrosurgical device, not an AI/ML system.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document is for an electrosurgical pencil, not an AI/ML device, and thus does not specify algorithmic performance metrics like sensitivity, specificity, or AUC against acceptance criteria. The "performance testing" mentioned is general validation for a medical device's function, not a specific study with AI-relevant metrics.

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

• Cannot be provided. This information is relevant for AI/ML device studies. The provided text doesn't describe a study with a "test set" in this context. It mentions "performance testing" to validate the device's function, but no details on sample size or data provenance in an AI/ML sense are given.

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)

• Cannot be provided. This information pertains to AI/ML model validation where ground truth is established for test data. The document describes an electrosurgical pencil, which doesn't involve such expert-driven ground truth establishment for its performance validation.

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

• Cannot be provided. This is relevant for AI/ML model validation, particularly when experts interpret data to establish ground truth. This concept does not apply to the electrosurgical device 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

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/ML systems where human readers interact with AI outputs. The document is for an electrosurgical pencil, not an AI-assisted diagnostic or therapeutic device.

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

• No, a standalone algorithm performance study was not done. This applies to AI/ML algorithms. The device is a physical electrosurgical pencil.

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

• Cannot be provided. This is a concept related to evaluating AI/ML models against a reference standard. For an electrosurgical pencil, "ground truth" would relate to its physical and electrical performance in a lab setting, not a medical "ground truth" from patient data.

8. The sample size for the training set

• Cannot be provided. This information is pertinent to AI/ML model development. There is no concept of a "training set" for the electrosurgical pencils described.

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

• Cannot be provided. Similar to the above, this is relevant for AI/ML model training. This document does not describe an AI/ML system.

Summary based on available information:

The provided 510(k) summary is for SHINMED various models of electrosurgical pencils (disposable models SW12200, SW12202, SW12300, and reusable models SW11100, SW11200, SW11202, SW11300).

The document states that the devices were compared to a legally marketed predicate device, the Gyrus PlasmaKinetic Superpulse System (510K No - K031085), with respect to intended use and technological characteristics.

Study Type:
The document mentions "performance testing has been done to validate the performance of the device." This implies traditional engineering and functional testing for a medical device to ensure it meets its intended specifications for cutting and coagulation, and hemostasis. However, no specific details about the methodology, sample sizes, or quantitative results of these performance tests are provided in this 510(k) summary. The focus of the 510(k) is to demonstrate substantial equivalence to a predicate device.

Conclusion:
This document details the submission for an electrosurgical pencil, a hardware medical device, and not an AI/ML-driven device. Therefore, the specific information requested, which is tailored for AI/ML performance evaluation (like acceptance criteria for AI metrics, test/training set details, expert ground truth establishment, MRMC studies, or standalone algorithm performance), is not present in the provided text. The "study" referenced is general performance validation for a hardware device against its functional requirements, rather than a clinical study evaluating diagnostic or prognostic accuracy of an algorithm.

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The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

The Shinmed Ultrasonic Nebulizer is a standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing. The device consists of a tabletop high-frequency main unit which provides an occillation frequency of 1.63 MHz. The 30 cc disposable medicine cup in the main unit. A mask or mouthpiece is attached to the main unit with a flexible hose. The patient breaths the medicine through the mask or mouthpiece.

The provided document is a 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer, focusing on its substantial equivalence to a predicate device. It contains very limited details regarding formal acceptance criteria or a dedicated study with statistical endpoints to "prove" the device meets acceptance criteria in the way a clinical trial for a new drug or algorithm would.

Instead, the document emphasizes equivalence in performance characteristics to a legally marketed predicate device. The "study" mentioned is a nebulizer characterization study, which compares the Shinmed device to the predicate device.

Here's an attempt to extract and present the requested information based on the provided text, with many fields being 'Not Applicable' or 'Not Specified' due to the nature of this type of regulatory submission (which focuses on equivalence rather than de novo performance proof).

Acceptance Criteria and Device Performance for Shinmed SW-966 Ultrasonic Nebulizer

The provided 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, the MicroSonic nebulizer (marketed as Lumiscope, K924081). The "acceptance criteria" can be inferred from the comparative performance data presented, which aims to show that the Shinmed device performs similarly to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "Nebulizer Characterization Studies" but does not detail the number of devices or measurement replicates used.
• Data Provenance: The device is manufactured by Shining World Healthcare Co., Ltd. in Taiwan. The characterization studies were presumably conducted by or for the manufacturer. No country of origin for the specific data collection is stated, nor is it explicitly labeled as retrospective or prospective. Given it's a pre-market submission, it would be prospective for the purpose of the submission.

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

• Not Applicable. This type of device (ultrasonic nebulizer) primarily relies on objective physical measurements (e.g., particle size, drug output) rather than expert interpretation or ground truth derived from expert consensus. The "ground truth" here is the physical performance measurement itself.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no expert interpretations involved in determining the core performance metrics, no adjudication method is necessary.

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

• No. An MRMC study is not relevant for this type of device. There are no human readers or interpretations of output typically associated with ultrasonic nebulizers.

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 a software algorithm. Its "standalone performance" is implicitly what the nebulizer characterization studies evaluated.

7. The Type of Ground Truth Used

• Objective Physical Measurements: The ground truth for performance relied on direct physical measurements of the nebulizer's output, specifically:
  • Median Particle Size (MPS) distribution (measured in microns).
  • Amount of drug delivered.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this physical device. The device's design and manufacturing processes are established, and its performance is verified through functional testing.

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

• Not Applicable. As there is no training set, this question is not relevant.

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