Search Results

The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. The stimulation function of the Mapping Suction Probe is used for monopolar stimulation during intraoperative surgical interventions and is connected to electrical stimulators of neuromonitoring devices outside the sterile field via an appropriate integrated connection cable. To ensure a correct monopolar stimulation, a counter electrode is also included in the sterile package which must be placed at the resection marqin. The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.

The provided text is an FDA 510(k) summary for a medical device called the "Mapping Suction Probe." It contains information about the device's indications for use, comparison to a predicate device, and performance data related to biocompatibility and bench testing.

However, the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

The provided document does NOT contain any information about AI, software, or clinical studies that would align with the detailed acceptance criteria and study design requested (e.g., MRMC studies, expert ground truth, training/test set sample sizes for AI models).

The document explicitly states:

• "The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it." (Page 8)
• "Clinical testing was not performed for the Mapping Suction Probe." (Page 9)

Therefore, based on the provided text, it's impossible to answer the majority of the questions related to AI/SaMD acceptance criteria and performance studies. The information available pertains to the physical device's safety and performance characteristics (biocompatibility, electrical safety, mechanical tests, etc.) compared to a predicate device, which is typical for a 510(k) submission for a non-software, non-AI hardware device.

Given the limitations of the provided text, I must state that the requested information (related to AI/SaMD acceptance criteria and studies) is not present in the document.

I will indicate which sections cannot be answered based on the input.

Acceptance Criteria and Device Performance (Based on available data, primarily biocompatibility and bench testing for a hardware device)

Since this is a physical device without AI/software components, the "acceptance criteria" are related to its physical and functional safety and equivalence to the predicate, rather than AI performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

| Category | Acceptance Criteria (based on standards/tests) | Reported Device Performance |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity: No reduction of cell proliferation/viability. | Cytotoxicity (Device): No reduction of cell proliferation/viability observed; dehydrogenase activity 101% at 100% extract conc.; no inhibition/lysis microscopically. Conclusion: Non-cytotoxic. |
| | Sensitization: 0% sensitization rate. | Sensitization (Device): 0% sensitization rate after application. Conclusion: No sensitizing properties. |
| | Irritation / Intracutaneous Reactivity: Primary irritation index of 0. | Irritation / Intracutaneous Reactivity (Device): Primary irritation index of 0 for polar and non-polar extracts. Conclusion: Not irritant. |
| | Acute Systemic Toxicity: No compound-related mortalities or signs of toxicity. | Acute Systemic Toxicity (Device): No compound-related mortalities or signs of toxicity within 72 hours post-dose. Conclusion: No acute systemic toxic characteristics. |
| | Material Mediated Pyrogenicity: Temperature increase for each rabbit not > 0.50°C. | Material Mediated Pyrogenicity (Device): Temperature increase for each rabbit not > 0.50°C. Conclusion: Materials considered non-pyrogenic. |
| | Hemolysis: Haemolytic indices < 2%. | Hemolysis (Device): Haemolytic indices: direct (0.11%) and indirect (0.08%) contact, both < 2%. Conclusion: Non-haemolytic. |
| | Bacterial Endotoxins: < 2.15 EU/device (for device); < 20.0 EU/device (for needle electrode). | Bacterial Endotoxins (Device): < 1.55 EU/test item. Conclusion: Non-pyrogenic. Bacterial Endotoxins (Needle Electrode): 0.6300, 0.7800, 0.6600 EU/test item. Conclusion: Non-pyrogenic. |
| Bench/Performance Testing | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40 and internal requirements for: Electrical Conductivity, Dielectric Strength, Impedance Measurement, Stimulation Current Test, Dimension of Components, Reached Vacuum in Air, Volumetric Flow Rate, Deformation Test, Leakage Test, Pull-out Force Test, Distractive Force Test, Mechanical Stability Test, Bending Stress Test, Insulation Test, Shelf-Life Tests. | Tests were performed on the subject device and/or its component according to the listed standards and internal requirements. Conclusion: "The testing and assessments performed demonstrate that the subject device performs comparable to the predicate device that is currently marketed for the same intended use." (Specific quantitative results for each bench test are not provided in the summary, only that they were performed and concluded comparability/compliance). |

Since the device is a physical instrument and not an AI/Software as a Medical Device (SaMD), the following points cannot be answered from the provided text:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No AI test set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI model.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication for AI.
• 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. No AI, no human reader study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth beyond physical tests and predicate device comparison.
• 8. The sample size for the training set: Not applicable. No AI training set.
• 9. How the ground truth for the training set was established: Not applicable. No AI training set.

Ask a specific question about this device