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Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation

The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:

Summary of Device Performance and Acceptance Criteria

Based on the provided documents, limited specific details are given regarding explicit acceptance criteria and corresponding reported device performance values in a quantitative manner. The submission primarily relies on a qualitative statement of performance verification.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Pre-clinical as well as bench top testing" but does not provide details on the number of samples or tests conducted.
• Data Provenance: The nature of the testing (pre-clinical, bench top) suggests controlled laboratory environments. There is no information regarding country of origin of data or whether it was retrospective or prospective in a clinical sense.

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

• Not applicable. The provided summary describes testing of an electrosurgical electrode and generator, which typically involves engineering and functional performance testing, not diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. As the testing is described as pre-clinical and bench top for an electrosurgical device, expert adjudication methods (like 2+1, 3+1) are not relevant.

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

• No. There is no mention of a multi-reader multi-case comparative effectiveness study. This type of study is typically relevant for interpretative diagnostic devices, not for an electrosurgical accessory.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is an electrosurgical electrode accessory, not a software algorithm or AI-based diagnostic tool. Therefore, a "standalone algorithm only" study is not relevant.

7. Type of Ground Truth Used

• Functional/Performance Standards: The ground truth would be established by engineering specifications, safety standards, and performance test protocols for electrosurgical devices (e.g., power output, safety cut-offs, tissue effect characteristics). The document generally states "performance requirements described," implying adherence to such standards.

8. Sample Size for the Training Set

• Not applicable. This device is a hardware accessory (electrosurgical electrode). The concept of a "training set" is typically associated with machine learning or AI models, which are not relevant here.

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

• Not applicable. As mentioned above, the concept of a training set and its ground truth does not apply to this type of medical device.

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Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa

The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The provided text is a 510(k) summary for a medical device accessory. For such devices, a detailed list of specific, quantifiable acceptance criteria and performance metrics is generally not included in the summary itself. Instead, the summary refers to a broader assessment of "performance requirements described" that are met through pre-clinical and bench-top testing. The actual detailed criteria would be in the full submission, which is not provided here.

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

The provided text does not include information on the sample size or data provenance (such as country of origin or retrospective/prospective nature) for any test set. The performance data section only states, "Pre-clinical as well as bench top testing has been performed to verify that the product meets the performance requirements described." This implies laboratory-based testing rather than studies involving patient data.

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

The provided text does not include information on the number or qualifications of experts used to establish ground truth. As noted above, the testing described appears to be pre-clinical/bench-top, not clinical, rendering this type of ground truth establishment less relevant for this submission.

4. Adjudication Method for the Test Set

The provided text does not include any information on an adjudication method for a test set. This would typically be relevant for clinical studies or studies involving expert assessment of outputs, neither of which are described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in the provided 510(k) summary. The summary focuses on pre-clinical and bench-top testing to demonstrate substantial equivalence, not a comparison of human reader performance with or without AI assistance.

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

The device is an "Electrosurgical Electrode" and an "Bipolar Electrosurgical Electrode" that is used "in conjunction with the Scuba Electrosurgical Generator." It is a physical accessory used by a surgeon. Therefore, no standalone (algorithm only) performance study was relevant or performed, as the device itself is not an algorithm or AI.

7. The Type of Ground Truth Used

Based on the description of "Pre-clinical as well as bench top testing," the ground truth would likely be established through engineering specifications, physical measurements, and possibly simulated tissue models to verify the device's functional integrity, power delivery, tissue effects (cutting, desiccation), and safety features (e.g., electrical insulation, temperature control). It would not involve expert consensus, pathology, or outcomes data in the typical sense for an AI/algorithm-based device.

8. The Sample Size for the Training Set

The provided text does not mention a training set or any machine learning/AI components. This device is a physical electrosurgical electrode, not an AI software.

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

As the device is a physical electrosurgical electrode and not an AI software, there is no training set and therefore, no process for establishing ground truth for a training set.

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The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.

The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff.

Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.

The provided text describes a medical device, the "Scuba System," which is a hysteroscopic electrosurgical device. It outlines its specifications, intended use, and provides a summary of non-clinical and clinical studies conducted to demonstrate its safety and effectiveness.

However, the text does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance metrics in a table, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.

The document describes comparative studies where the Scuba system was compared to existing technologies (monopolar electrosurgery, laser surgery, and the Erbotom Generator with Karl Storz accessories). These comparisons are intended to demonstrate substantial equivalence, a common requirement for 510(k) submissions.

Here's a breakdown of what can be inferred and what is missing based on your request:

What can be inferred/extracted:

• Device: Scuba System (Hysteroscopic Electrosurgical Device)
• Intended Use: Tissue cutting, vaporization, and desiccation in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
• Study Type: Comparative studies against predicate devices (monopolar electrosurgery, laser surgery, Erbotom Generator).
• Non-Clinical Studies:
  • In vivo studies using porcine animal models (stomach test model and skin flap model in live swine) to demonstrate vaporization and coagulation of live tissue.
  • Biocompatibility testing.
• Clinical Studies (Extirpated Uteri):
  • One study compared the Scuba system to monopolar electrosurgery and laser surgery, finding it "as effective in cutting and coagulating uterine tissue."
  • Another study used ten extirpated uteri, comparing the Scuba and Erbotom Generator side-by-side in each uterus. Both devices were "effective in excising and coagulating uterine tissue."
  • Ground Truth Type for Clinical Studies (Extirpated Uteri): Histological evaluation of tissue effects was performed, indicating a form of "pathology" or "expert assessment of tissue damage." Serosal temperature measurements were also recorded.

What is explicitly MISSING from the provided text:

1. A table of acceptance criteria and the reported device performance: The text states the device was "as effective" or "performed similarly" to predicate devices but does not provide specific quantitative performance metrics or a formal acceptance criteria table.
2. Sample size used for the test set and the data provenance: Only "ten uteri" are mentioned for one clinical study. No information on data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is an electrosurgical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrosurgical device operated by a human.
7. The type of ground truth used: For in vivo animal studies, it was observed tissue effects. For ex vivo human uterine studies, it involved histological evaluation and temperature measurements. This is broadly "pathology" or "direct observation/measurement of tissue effects."
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable for the same reason.

Conclusion:

The provided document (K9624822, 510(k) Summary for the Scuba System) focuses on demonstrating substantial equivalence through comparative studies of its electrosurgical capabilities. It lacks the detailed information typically associated with the evaluation of AI/ML-based diagnostic devices, particularly regarding acceptance criteria, specific performance metrics, expert roles, and data set characteristics (training/test sets, provenance, adjudication methods) that would be relevant for such systems.

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