Search Results

Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal stenlization or tubal coagulation for sterilization procedures and should not be used for these procedures.

These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

Important Note: The provided text only describes a 510(k) summary for a medical device (Stingray Electrosurgical Forceps). A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, not necessarily detailed performance criteria or clinical efficacy studies as would be required for a novel device or a PMA. The information requested in the prompt, such as acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, are not present in the provided document.

Therefore, the following response will indicate where the requested information is absent.

Acceptance Criteria and Study Details for Stingray Electrosurgical Forceps (K123478)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K083162) and changes to instructions for use, particularly sterilization and cleaning. It does not provide explicit, quantitative acceptance criteria for device performance or a detailed study demonstrating that these criteria have been met in the format typically seen for novel product performance. The "reported device performance" in the table above is derived from statements about validation and testing mentioned in the document.

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

• Sample Size for Test Set: Not specified. The document mentions validation through "twenty (20) sterilization cycles" and "forty (40) sterilization cycles" for an unspecified number of devices, which relates to the device's durability rather than a clinical test set.
• Data Provenance: Not specified. The description of testing (sterilization cycles) suggests laboratory-based validation, not clinical data provenance (country of origin, retrospective/prospective).

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

• Number of Experts: Not applicable/not specified. The provided text describes engineering/technical validation (sterilization cycles), not a study requiring expert-established ground truth.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The validation described (sterilization cycles) does not involve adjudication.

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

• MRMC Study Done: No. The device is an electrosurgical forceps, a surgical instrument. MRMC studies are typically performed for diagnostic imaging or AI-assisted diagnostic devices to assess how AI affects human interpretation. This type of study is not relevant or described for this device.
• Effect Size of Human Reader Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. This device is a manual surgical instrument. The concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable to an electrosurgical forceps.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" implied by the testing described relates to the physical integrity and continued functionality of the device after repeated sterilization, determined by engineering assessments, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. This device does not involve a "training set" in the context of machine learning or AI models.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable/not specified. This concept is not relevant to the described device or the 510(k) submission.

Ask a specific question about this device

Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Ultralite Disposable Irrigation Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

These devices are disposable bipolar forceps design for single use in general surgical procedures. They are connected through a suitable birolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate, or irrigate selected tissues. The semi rigid irrigation tube is designed to carry nonpyrogenic fluid through the instrument and outputted to the tip end. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick alloy tip. The devices are provided sterile ethylene oxide (ETO) and in sterile packs.

The provided text describes a 510(k) summary for the "Stingray Ultralite Disposable Irrigation Bipolar Forceps." This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested elements are not applicable to this type of medical device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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 applicable as the submission relies on documentation of a previously cleared predicate device and adherence to established standards, not a specific "test set" of data for performance evaluation in the way an AI/imaging device would. The "study" referenced for the predicate device appears to be bench and standards testing.

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. The device is a surgical instrument, and its safety and effectiveness are established through engineering design, material selection, manufacturing processes, and compliance with recognized industry standards, not through expert-labeled ground truth like in an AI/imaging study.

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

This information is not applicable. The evaluation method described is a comparison to a predicate device and adherence to industry standards, not a review of a data set that would require 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. This submission concerns a physical surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

This information is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this type of device is inherent in its design, manufacturing, and compliance with recognized safety and performance standards for electrosurgical instruments. The safety and effectiveness of the predicate device (K083162) would have been established through bench testing and adherence to relevant industry standards (ANSI/AAMI HF18-2001, IEC 60601-2-2:2006).

8. The sample size for the training set:

This information is 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:

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

Ask a specific question about this device

Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.

Here's an analysis of the provided 510(k) summary regarding the Stingray Electrosurgical Forceps, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a predicate device comparison rather than explicit acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is therefore reported as being "SAME" or equivalent to the predicate device's characteristics.

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

• Sample Size: Not specified. The document refers to "bench and standards testing data" (Section 5. Safety and Effectiveness, comparison to predicate device, and Section 7. Conclusion), but does not provide details on the number of samples or specific test configurations used.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the tests were retrospective or prospective. It only states that "bench and standards testing" was conducted.

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

Not applicable. This device is not an AI/ML or diagnostic device that requires expert ground truth establishment for a test set. The evaluation is based on engineering and safety standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described as the evaluation is based on objective bench and standards testing.

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

No. This is a medical device (electrosurgical forceps), not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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 inherent to its design and manufacturing, evaluated through bench testing against established standards and comparisons to a predicate device.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this device is compliance with established engineering standards (60601-2-2, ANSI/AAMI HF18-2001) and demonstrated equivalence in physical and functional characteristics to a legally marketed predicate device (ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997). This falls under the category of bench testing and standards compliance.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this device.

Ask a specific question about this device