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The LaparoLight™ Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.

LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.

In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.

The provided document is a 510(k) premarket notification for a medical device called the LaparoLight™ Veress Needle. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-driven diagnostics. Instead, it describes tests performed to demonstrate substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding performance data presented for the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the Veress Needle, "acceptance criteria" are usually framed as meeting design specifications, industry standards, and demonstrating equivalence to a predicate device through various tests.

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

• Sample Size: Not specified in the document for any of the performance tests. These are typically bench tests, and the "sample size" would refer to the number of devices tested.
• Data Provenance: Bench testing performed on the device itself.
  • No patient data (retrospective or prospective) is involved, as this is a physical medical instrument, not a diagnostic algorithm.
  • No country of origin of data is specified, as it's laboratory testing.

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

• Not Applicable. This is a physical device, and "ground truth" as it relates to expert consensus for diagnostic tasks is not relevant. The "ground truth" for these tests would be the design specifications and established engineering principles.

4. Adjudication Method for the Test Set

• Not Applicable. Again, this concept applies to diagnostic or interpretative tasks where expert agreement is needed to establish a correct answer. For bench testing of a physical device, the outcome is typically objectively measurable (e.g., force, electrical parameters).

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. This is a physical surgical instrument and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

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

• No. This device is not an algorithm. It's a physical medical instrument used by a human surgeon. Standalone performance as it relates to AI is not applicable.

7. The Type of Ground Truth Used

• Engineering Specifications and Industry Standards: For the performance tests (e.g., electrical safety, EMC, biocompatibility), the "ground truth" is compliance with recognized engineering standards (e.g., ISO, AAMI/ANSI, IEC) and the device's own design specifications. For the comparative tests (force, bond strength), the "ground truth" is equivalence to the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. See point 8.

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LaparoVue is a single-use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

The Laparo Vue is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile (radiation) and intended for single-use only in a healthcare facility / hospital. The LaparoVue is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by LEDs which are illuminated at each port. The LaparoVue has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 12mm in diameter. The horizontal port is the main warming port, primarily used prior to the surgical case to warm the scope before the insertion into a body cavity. A small scope stand is part of the LaparoVue, designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. The vertical port contains a sponge that is saturated with the surfactant solution and warmed when the device is active. This port allows for the user to apply the warmed surfactant prior to and during the case. The LaparoVue is powered by alkaline batteries and has a single-use surgical life of a minimum of 5 hours. A small piece of microfiber is attached to the main housing of the unit that would allow the user to physically wipe the lens to remove any debris throughout the surgical procedure. The VueTip trocar swabs are an accessory that is provided in the same package with the LaparoVue. They are each a sterile, single-use accessory to be used to physically clean debris from the trocar/cannula to minimize any smudging of the scope lens when it is inserted. The trocar swabs are constructed using foam attached to a handle, where the foam is used for the mechanical wiping of the port of the trocar/cannula. Two different configurations are provided, one with a foam diameter intended for use with trocar/cannulas up to 7mm, and the other for trocar/cannula with a diameter from 7mm up to 12mm. The handle material for the VueTip trocar swab is constructed to be radiopaque for the surgical setting. A microfiber cloth is an accessory that is provided in the same package with the Laparo Vue. The cloth is a sterile, single-use accessory to be used as an alternate method to physically wipe debris from the lens of scope during the case. The construction of the microfiber cloth is radiopaque for the surgical setting.

This FDA 510(k) summary for the LaparoVue device primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the LaparoVue itself. The document describes types of performance tests conducted but does not provide specific acceptance criteria or reported device performance values from those tests in a way that allows for a direct comparison as requested.

Therefore, many of the requested sections cannot be fully populated from the provided text.

Here is an attempt to address your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes types of performance tests but does not explicitly state numerical acceptance criteria or provide quantitative reported device performance values for the LaparoVue device for fogging prevention. The "Lens Fogging Validation" section notes that "digital images were recorded to demonstrate the effectiveness of preventing the fog from forming on the lens when the Laparo Vue was utilized," implying a qualitative assessment rather than a specific numerical metric.

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

• Test Set Sample Size: Not explicitly stated for any of the performance tests. The document mentions "digital images" for fogging, but not the number of tests/scopes.
• Data Provenance: All listed performance data (Biocompatibility, Sterilization, Electrical Safety/EMC, Life Expectancy, Lens Fogging Validation) appear to be from bench testing conducted by Buffalo Filter, LLC. No information is provided regarding the country of origin of the data beyond the manufacturer's location in the US. The studies are prospective in the sense that they were conducted for this 510(k) submission.

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

Not applicable for the bench studies described. These studies did not involve human interpretation or a "ground truth" derived from expert consensus. For the "Lens Fogging Validation," the assessment appears to be a direct physical observation or image analysis, not expert medical opinion.

4. Adjudication Method for the Test Set

Not applicable, as no expert review or adjudication process is described for the bench performance tests.

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

No MRMC comparative effectiveness study was done. The document explicitly states:

• "No animal testing was conducted for this submission"
• "No clinical testing was conducted for this submission"

This indicates that no studies involving human readers or clinical cases were performed.

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

Yes, the performance tests described (Biocompatibility, Sterilization, Electrical Safety/EMC, Life Expectancy, Lens Fogging Validation) are all standalone bench tests focused on the device's intrinsic performance characteristics without human interaction beyond operating the device for the test. The "Lens Fogging Validation" assessed the device's ability to prevent fogging directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The closest concept to "ground truth" for the performance tests would be:

• Established standards: For Biocompatibility (ISO 10993), Sterilization (AAMI/ANSI/ISO 11137, 11737; ASTM F2096), and Electrical Safety/EMC (IEC 60601-1, 60601-1-2).
• Direct physical measurement/observation: For Life Expectancy (recording temperatures over time) and Lens Fogging Validation (qualitative observation/recording of fog presence in a simulated environment).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for this device.

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