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510(k) Data Aggregation
(61 days)
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.
The provided text is a 510(k) summary for the SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000. It describes the device, its indications for use, and some of the testing performed to demonstrate its safety and effectiveness.
However, the document does not contain specific acceptance criteria values or detailed study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC study details) that would allow for a comprehensive answer to your request regarding acceptance criteria and performance studies. The "TESTING" section briefly mentions the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and aid in smoke evacuation, but it doesn't quantify these abilities with specific metrics or acceptable ranges.
The only specific performance detail mentioned is related to sterilization:
- Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137:2006 and AAMI TIR 27:2001.
Therefore, based only on the provided text, a complete table of acceptance criteria and device performance as requested, along with details about sample sizes, experts, adjudication, and specific study types (like MRMC or standalone), cannot be fully generated.
Here's what can be extracted and what is missing, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (from text) |
|---|---|
| Sterility | Achieves a Sterility Assurance Level (SAL) of 10-6. |
| Pneumoperitoneum Maintenance | Tested to show its ability to maintain adequate pneumoperitoneum during laparoscopic surgery. |
| Smoke Evacuation | Tested to show its ability to aid in the evacuation of smoke. |
| Port of Entry creation/maintenance | Tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
Note: The acceptance criteria for pneumoperitoneum maintenance, smoke evacuation, and port of entry are descriptive ("adequate," "aid in," "ability to create and maintain") rather than quantifiable metrics with specific thresholds. The document does not provide the numerical results or the specific acceptance thresholds for these aspects beyond stating that they were tested successfully.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing is generally referred to as "simulated laparoscopic surgery."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text. The testing mentioned in the document appears to be primarily laboratory/technical testing rather than human-expert-driven ground truth establishment for a diagnostic algorithm.
4. Adjudication method for the test set
- Not applicable/Not specified in the provided text. (No diagnostic algorithm or expert review for ground truth 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
- Not applicable/Not specified in the provided text. This is a medical device (trocar and insufflator), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified in the provided text. This is a medical device, not an algorithm. The device itself performs functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Sterility: Established based on compliance with ISO 11137:2006 and AAMI TIR 27:2001 standards.
- For Functional Performance (Pneumoperitoneum, Smoke Evacuation, Port of Entry): The text implies that the ground truth was based on the device's ability to perform these functions during "simulated laparoscopic surgery" in a manner deemed "adequate" or successful. No further details on how "adequacy" or "success" were quantitatively defined and measured are provided.
8. The sample size for the training set
- Not applicable/Not specified in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning solution.
9. How the ground truth for the training set was established
- Not applicable/Not specified in the provided text. No training set is mentioned.
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(83 days)
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.
SurgiQuest AirSeal™ Optical Trocar & Cannula System
This document is a 510(k) premarket notification from the FDA, primarily concerned with establishing substantial equivalence for the SurgiQuest AirSeal™ Optical Trocar & Cannula System to legally marketed predicate devices. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study data.
My analysis of the provided text confirms that the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, nor data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect sizes.
- Results from a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
- The sample size for a training set.
- Information on how ground truth for a training set was established.
This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of device performance studies. Therefore, it lacks the specific study design and results information you are looking for.
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(52 days)
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.
Acceptance Criteria and Device Performance Study for SurgiQuest™ AirSeal™ Optical Trocar & Cannula System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it describes functional requirements and the types of testing performed to demonstrate compliance. The "Reported Device Performance" column reflects what the document states the testing showed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance for Surgical Use: | |
| Ability to create and maintain a port of entry during simulated laparoscopic surgery. | The device has been tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Ability to maintain adequate pneumoperitoneum during simulated laparoscopic surgery. | It has also been tested to show its ability to maintain adequate pneumoperitoneum during the course of simulated laparoscopic surgery. |
| Minimize CO2 consumption during minimally invasive surgery. | The recirculation and filtration pump is designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. (Testing is implied for this design feature but not explicitly stated as a direct test of CO2 consumption rates in the summary). |
| Safety and Sterility: | |
| Compliance with electrical safety and emissions standards (IEC60601-1, IEC60601-1-2). | The unit will be tested for safety and emissions in accordance with IEC60601-1, General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems and IEC60601-1-2, General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. (Implies compliance was achieved). |
| Achieves a Sterility Assurance Level (SAL) of 10-6. | Sterility validation is in accordance with ISO 11137:2006 (Part 1) and AAMI TIR 27:2001. A Sterility Assurance Level (SAL) of 10-6 is achieved. |
| Biocompatibility (implied for medical devices) | Composed of medical grade materials. (Specific testing for biocompatibility is not detailed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the functional performance testing (e.g., number of simulated procedures or test subjects). It states "simulated laparoscopic surgery" for the functional tests.
For sterility validation, ISO 11137:2006 and AAMI TIR 27:2001 are referenced, which are standards for radiation sterilization dose substantiation. These standards inherently involve a statistically significant number of samples, but the exact number for this specific device is not detailed in the summary.
Data Provenance: The data provenance is internal to the manufacturer, SurgiQuest, Inc., as evidenced by the statement "The device has been tested to show..." and "The unit will be tested...". The testing appears to be primarily prospective as it's for pre-market notification to determine substantial equivalence. The country of origin for the data is implicitly the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of experts to establish a "ground truth" for the functional performance testing. The description indicates engineering and performance testing against industry standards and simulated conditions, rather than expert clinical evaluation for a specific medical outcome. For the safety and sterility testing, the "ground truth" is established by adherence to recognized international standards (IEC, ISO, AAMI).
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as the testing described does not involve subjective interpretations or multiple readers requiring consensus.
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. The SurgiQuest™ AirSeal™ Optical Trocar & Cannula System is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding "human readers improving with AI vs without AI assistance" is not relevant to this device.
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.
7. The Type of Ground Truth Used
For functional and safety testing, the ground truth is established by:
- Performance against defined simulated conditions: For creating/maintaining port of entry and pneumoperitoneum.
- Adherence to recognized international standards: IEC60601-1, IEC60601-1-2 for electrical safety and emissions; ISO 11137:2006 and AAMI TIR 27:2001 for sterility.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "training" for the device would be its manufacturing and design optimization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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