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The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.

The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that fits onto the distal end of a trocar and with its lens wiper serves to clean the camera lens from blood, tissue, fog, grease, and other surgical debris. The lens wiper itself is a mechanical device within the TroKit that employs a thermoplastic elastomer squeegee. The TroKit is translucent. When the laparoscopic camera is inserted through the trocar into the TroKit its insertion opens the mechanical jaws that house the lens wiper. The wiping is done automatically upon the passage of the laparoscopic camera through the TroKit jaws. The TroKit can be activated and used multiple times during surgery. One device is adequate for one surgery.

The provided FDA 510(k) summary for the TroCare TroKit Laparoscope Lens Wiper (K241796) focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and non-clinical performance data. It does not contain information related to the acceptance criteria and study design elements specified in the request, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or details about the training set.

Based on the document, here's what can be extracted and what information is missing:

Information available from the document:

• Type of Ground Truth Used: Non-clinical testing demonstrates that the subject device "performs as well as the legally marketed predicate device." The performance data section specifies "mechanical characteristics" testing to show it is safe and performs as intended. Implied ground truth is the performance of the predicate device and established safety and performance benchmarks for such devices.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable as this is a physical medical device, not an AI/ML algorithm.

Information NOT available from the document:

1. A table of acceptance criteria and the reported device performance: While the document states "The TroKit Laparoscope Lens Wiper was evaluated for mechanical characteristics to demonstrate that it is safe and performs as intended," it does not provide a table with specific acceptance criteria (e.g., in terms of cleaning effectiveness, durability, or ease of use) nor the reported quantitative device performance against those criteria.
2. Sample sized used for the test set and the data provenance: The document indicates that "non-clinical testing" was performed, but it does not specify the sample size of devices tested or any details about data provenance (e.g., country of origin, retrospective or prospective).
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): Since this is not an AI/ML device, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or diagnosis is not applicable here. The evaluation of mechanical characteristics would typically involve engineers or laboratory personnel following test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the non-clinical mechanical testing 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: The device is a physical laparoscopic lens wiper, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence based on design, indications for use, and non-clinical mechanical and biocompatibility testing. The detailed information requested, particularly concerning performance metrics, test set specifics, and expert involvement for ground truth, is typically provided for AI/ML-driven devices or more complex diagnostic tools, which this device is not.

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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the lens of the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.

The provided document describes the troCarWash™ System, a device intended to remove visual obstructions from the distal lens of a laparoscope during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it details various validation and testing activities with implied acceptance criteria being successful completion of these tests according to specified standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Packaging Validation: The sample sizes are not explicitly stated for each test within the packaging validation.
• Sterilization Validation: The sample sizes are not explicitly stated for each test within the sterilization validation.
• Biocompatibility Testing: The sample sizes for these tests are not explicitly stated.
• Electrical Safety & EMC: The sample sizes for these tests are not explicitly stated.
• Software V&V Testing: Not applicable for a sample size in this context.
• Bench Performance Testing:
  • Test Set Size: 29 disposable sets (preconditioned with sterilization and accelerated aging) and 8 disposable sets (preconditioned with sterilization and simulated transportation and distribution) were tested.
  • Data Provenance: The document does not specify the country of origin of the data. It is a benchtop model study, implying it was conducted in a controlled laboratory environment. The tests involved preconditioned (sterilized, aged, and simulating transport) devices, indicating a prospective testing approach on manufactured devices.

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)

Not applicable. The ground truth for the performance of this device (e.g., wash efficacy, sterilization, biocompatibility) is established through objective physical, biological, and electrical measurements against established international and industry standards, not by expert interpretation in the sense of medical image analysis or diagnosis.

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

Not applicable. This type of adjudication method is relevant for studies involving human interpretation of data (e.g., medical images). The studies described here are primarily objective validation and bench performance tests against predefined standards.

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 MRMC comparative effectiveness study was done. The device is a physical cleaning system for laparoscope lenses, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.

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

A standalone performance evaluation was indeed done for the device's functional aspects:

• Bench Performance Testing: This test specifically evaluated the "system performance" and its "wash efficacy" using various scope angles and brands in a "benchtop model." This implies an algorithm-only or device-only performance evaluation without direct human intervention in the cleaning process itself beyond initiating the cycle. The device "utilizes a light sensor to detect the position of the scope as the user pulls the scope back within the trocar to deliver a cleaning cycle," and "incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism." This confirms the automated, standalone operation for its core function.

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

The ground truth for the various tests outlined is based on:

• Bench Performance Testing: The ground truth for "acceptable cleans" is implied to be visually clear lenses after the cleaning cycle, as determined by direct observation in the benchtop model. The document states "the troCarWash™ system was able to achieve acceptable cleans." While not explicitly defined as a quantified "ground truth" metric (like µg/cm² of residue), the pass/fail nature against visual clarity is the de facto ground truth.
• Packaging, Sterilization, Biocompatibility, Electrical Safety & EMC, Software V&V: The ground truth for these validations is compliance with specific international and national standards (e.g., ASTM, ISO, ANSI AAMI, IEC, FDA guidance documents). Successful completion according to the parameters and thresholds defined in these standards constitutes the ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. Its function is mechanical cleaning and physical/chemical interaction, governed by established engineering principles and materials science. While "software" is mentioned as having undergone V&V, it is for controlling the physical cleaning mechanism.

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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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.

The provided FDA 510(k) summary for the troCarWash™ System focuses on a device that removes visual obstructions from laparoscope lenses during surgery. The submission describes various non-clinical tests (packaging, sterilization, biocompatibility, electrical safety/EMC, software verification/validation, and bench performance testing) to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the specific information required to answer many parts of your request, particularly regarding:

• Acceptance criteria values for performance (e.g., target accuracy, sensitivity, specificity, or specific cleaning efficacy metrics). The text states "the troCarWash™ system was able to achieve acceptable cleans" but doesn't quantify what "acceptable" means.
• Detailed study design for performance evaluation beyond "Bench Performance Testing." While it mentions "wash efficacy," it doesn't provide specific metrics.
• Sample size and data provenance for a "test set" in the context of AI/ML or comparative studies with human readers.
• Details on expert ground truth establishment, adjudication methods, or MRMC studies.
• Information about a training set for an AI/ML model or how its ground truth was established. This device is a mechanical cleaning system, not an AI/ML diagnostic or therapeutic device, so these concepts (training set, experts for ground truth) likely don't apply in the way you're asking.
• Standalone performance metrics (e.g., Sensitivity, Specificity, AUC) typical of AI/ML devices.

Based on the provided document, here's what can be inferred and what information is missing:

Device Description: The troCarWash™ system is a laparoscopic lens cleaning device consisting of a reusable control unit and a disposable, sterile, single-use trocar. It removes visual obstructions (condensation, blood, tissue particulates) from the distal lens of a laparoscope to maintain a clear image during surgery. It uses medical-grade CO2 and saline for cleaning.

Nature of Device: This is primarily a mechanical/electromechanical device, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions related to AI/ML specific performance metrics (e.g., human reader improvement with AI assistance, training data, ground truth establishment by experts for AI models) do not directly apply to the described device and the information provided. The "Software Verification and Validation Testing" section explicitly states the software was considered "minor" level of concern, implying it's not performing complex diagnostic or decision-making functions typically associated with AI.

Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or performance metrics for wash efficacy (e.g., percentage of debris removed, clarity score), a table as requested cannot be fully populated. The closest statement is:

Study Information (Based on available text):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for Wash Efficacy: Not explicitly quantified in the provided text. It states "acceptable cleans."
   • Reported Device Performance for Wash Efficacy: "The study demonstrated that with various scope angles and brands, the troCarWash™ system was able to achieve acceptable cleans." (No quantitative metrics provided).

2. Sample sized used for the test set and the data provenance:

   • Sample Size: "29 disposable sets (trocar, obturator, and tubing set) preconditioned with sterilization and accelerated aging and 8 disposable sets preconditioned with sterilization and simulated transportation and distribution were tested for wash efficacy." This totals 37 disposable sets.
   • Data Provenance: The document does not specify the country of origin. The study was a "benchtop model" performance test, implying controlled laboratory conditions rather than retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This device is evaluated for its mechanical cleaning performance, not for diagnostic accuracy requiring expert interpretation or ground truth labeling in the context of an AI/ML model. The "acceptable cleans" would likely have been determined against pre-defined visual or technical criteria, not expert consensus on medical images.

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

   • Not applicable. This type of adjudication method is used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements and establish ground truth for image-based diagnostic systems. It is not relevant for a mechanical cleaning efficacy test.

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, an MRMC study was not done. The document explicitly states: "No clinical data was necessary to support a claim of substantial equivalence." This type of study is typically performed for AI/ML diagnostic aids to show improvement in human reader performance.

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

   • The "Bench Performance Testing" section describes testing the system's ability to clean without direct human intervention in the cleaning process itself (though human operation initiates the cycle). However, this is not "standalone algorithm performance" in the context of AI/ML, but rather the performance of the device's mechanical function. No specific quantitative diagnostic metrics (like sensitivity, specificity, AUC) are provided.

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

   • For wash efficacy: The ground truth would likely be defined by pre-established physical/visual criteria for lens cleanliness after contamination, rather than expert consensus on medical images or pathology. The document doesn't detail these criteria, only that "acceptable cleans" were achieved.
   • For other tests (packaging, sterilization, biocompatibility, electrical safety): Ground truth is established by compliance with recognized industry standards and test methods.

8. The sample size for the training set:

   • Not applicable / Not specified. This device is not an AI/ML model that requires a "training set" in the computational sense. Its design and operation are based on engineering principles, and its software is "minor" in terms of risk, suggesting it's primarily for control, not learning.

9. How the ground truth for the training set was established:

   • Not applicable. As no AI/ML training set is mentioned or implied, this question does not apply.

Summary of Gaps: The provided text is a 510(k) summary for a mechanical device, emphasizing its substantial equivalence through non-clinical performance and safety testing. It lacks the quantitative performance metrics, study design details, and specific AI/ML related information (training sets, expert ground truth, adjudication, MRMC studies) that your questions are designed to uncover for AI/ML medical devices.

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The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.

The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.

The provided document is a 510(k) summary for a medical device (Trocar), not a study proving an AI device meets acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and non-clinical performance testing. Therefore, it does not contain the information requested about acceptance criteria, test sets, expert involvement, and statistical analyses typical for AI/ML device validation studies.

Specifically, the document does not provide information on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes for a test set (it mentions in-house non-clinical tests, but not a large-scale clinical test set for AI).
3. Data provenance for a test set.
4. Number of experts or their qualifications for establishing ground truth for a test set.
5. Adjudication method for a test set.
6. Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human readers improving with AI assistance.
7. Standalone performance of an algorithm (as it's a physical device).
8. Type of ground truth used (e.g., pathology, outcomes data).
9. Sample size for a training set (not an AI/ML device).
10. How ground truth for a training set was established.

Instead, the document states:

Acceptance Criteria & Device Performance (for the physical Trocar device):

• Acceptance Criteria (Implied): The device is expected to meet various performance requirements related to its function, biocompatibility, and sterilization. Specifically, the document mentions:

  • Biocompatibility as per ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity).
  • Sterilization validation per ISO 11135:2014.
  • Specific performance aspects: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, Trocar Insertion/Removal force.

• Reported Device Performance: The document states, "All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide specific numerical or qualitative results for each criterion; rather, it makes a general statement of compliance.

Study Proving Device Meets Acceptance Criteria:

• Type of Study: Non-clinical testing (bench testing, biocompatibility testing, sterilization validation). This is conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
• Sample Size Used for Test Set: Not specified. The document only mentions that "a series of tests were performed" and "The performance testing conducted on subject device is listed below." No quantitative sample sizes for these tests are provided.
• Data Provenance: Implied to be in-house testing conducted by the manufacturer in China, as per their address. It's non-clinical, so "retrospective or prospective" is not directly applicable in the same way it would be for patient data.
• Number of Experts/Qualifications & Adjudication Methods: Not applicable, as this is a physical medical device undergoing bench and biocompatibility testing, not an AI/ML assessment involving human interpretation of data.
• MRMC Comparative Effectiveness Study/Standalone Performance: Not applicable for a physical surgical instrument.
• Type of Ground Truth: The ground truth for this device's performance is objective measurements against established engineering specifications, biocompatibility standards (e.g., ISO 10993), and sterilization standards (e.g., ISO 11135).
• Training Set/Ground Truth for Training Set: Not applicable, as this is not an AI/ML device.

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Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.

The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.

Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.

The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.

The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The provided document (K080871) is a 510(k) summary for "Titanium Needle Sets." In a 510(k) submission for this type of device, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, particularly for devices like interstitial needles which are accessories to a larger system. Performance is generally assessed through design specifications, material compatibility, and intended use alignment rather than through new clinical outcome studies with predefined statistical acceptance criteria typical of novel therapies or diagnostics.

The document states:

• "The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures."
• "The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images."
• "The modified device has the same intended use as the legally marketed predicate device cited."
• "The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946."

Based on the available text, specific quantitative acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of artifact reduction) are not detailed. The "performance" is implicitly demonstrated through the claim of CT/MR compatibility with minimal artifacts and the overall substantial equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical study with a "test set" in the context of diagnostic or interventional performance. The "test" in this submission would likely refer to engineering verification and validation testing (e.g., material compatibility, dimensional accuracy, sterilization efficacy, imaging compatibility) rather than a clinical trial. Therefore, sample sizes for a clinical test set are not applicable here.

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)

Not applicable, as no clinical "test set" requiring ground truth established by experts is described for this type of 510(k) submission.

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

Not applicable, as no clinical "test set" requiring adjudication for ground truth is 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. This device is an interstitial needle for brachytherapy, not an AI-powered diagnostic or decision support tool.

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

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

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

Not applicable, as no clinical "test set" requiring ground truth is described. For a device like this, the "ground truth" would relate to its physical properties and performance (e.g., actual dimensions matching specifications, material composition, artifact presence in imaging under controlled conditions).

8. The sample size for the training set

Not applicable. This document is not describing a machine learning or AI algorithm development.

9. How the ground truth for the training set was established

Not applicable. This document is not describing a machine learning or AI algorithm development.

In summary:

The provided 510(k) document is for a medical device accessory (Titanium Needle Set) and aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically relies on comparing design, materials, and intended use, along with non-clinical performance data (e.g., imaging compatibility, mechanical robustness, biocompatibility), rather than extensive human-in-the-loop clinical studies with statistical acceptance criteria. Therefore, most of your requested information related to comprehensive clinical study design and performance metrics is not present in this regulatory submission.

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Temporary implant for ventilation and drainage of middle ear.
Temporary implant for ventilation or drainage of the middle ear.

The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 77 ETD Trocar Ventilation Tube:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative or pass/fail format that would be typical for a device performance study. Instead, it justifies the device's safety and effectiveness through a comparison to a predicate device and by highlighting design modifications that are presented as improvements or at least not introducing new risks. Therefore, the "acceptance criteria" inferred here are based on the claims made about the device's design and its impact on the procedure and patient safety.

2. Sample size used for the test set and the data provenance

The document does not describe a specific clinical study with a test set of human subjects or data. The submission relies on a comparison to a predicate device and statements about the inherent properties of the materials and design. The only "testing" mentioned is MRI compatibility testing, which is a bench test, not a clinical study on a test set.

• Sample Size (Test Set): Not applicable, no clinical test set described.
• Data Provenance: Not applicable, no clinical data described beyond material properties and design rationale.

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 a test set is established as there is no clinical test set described. The evaluation is based on engineering design, material properties, and comparison to existing technology.

4. Adjudication method for the test set

Not applicable, as no test set or clinical study is 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. This is not an AI/software device, and no MRMC study or any clinical comparative effectiveness study is described.

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, so standalone performance is not relevant in this context.

7. The type of ground truth used

The "ground truth" in this context is implicitly established by:

• Material properties and historical use: The safety of gilded silver, pure titanium, and surgical stainless steel is well-established through their long history of use in medical devices.
• Engineering design principles: Claims about precise cuts, secure placement, and reduced trauma are based on the mechanical design of the device and how it interacts with the tympanic membrane.
• Predicate device comparison: The substantial equivalence argument relies on the established safety and effectiveness of the existing K 973226 models.
• MRI compatibility testing: This bench testing provides "ground truth" for the device's behavior in an MRI environment.

8. The sample size for the training set

Not applicable, as no training set for a machine learning algorithm or clinical data for training is described.

9. How the ground truth for the training set was established

Not applicable, as no training set is described.

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Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for providing a well anchored and gas tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.

The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.

The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.

The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential.

The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space.

The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed.

The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.

The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.

The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.

If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.

The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw.

This document is a 510(k) Summary of Safety and Effectiveness for Pajunk GmbH's Trocars, Trocar Sleeves, Distension System, and Anchoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.

Therefore, many of the requested categories for describing a study proving acceptance criteria cannot be directly extracted from this type of regulatory submission. This document primarily asserts that the new devices are substantially equivalent to existing, legally marketed predicate devices, meaning they have similar features, intended uses, and do not raise new issues of safety or effectiveness.

Here's an analysis based on the provided text, highlighting where information is available and where it is not:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of specific acceptance criteria (e.g., performance metrics like penetration force, sealing integrity, or specific clinical outcomes) nor does it report detailed device performance data against such criteria. The "acceptance criteria" here is met through the demonstration of substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on an equivalency claim rather than new clinical data from a dedicated test set. The data provenance would be a comparison to existing predicate devices already on the market.

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)

Not applicable. Ground truth, in the context of device performance, would typically be established through clinical observation or objective measurements. This document does not describe such a process for a new clinical trial. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices.

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

Not applicable. No test set requiring adjudication in the clinical study sense is 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. This device is a surgical tool, not an AI diagnostic/interpretive system. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is not an algorithm-only device. It is a manually operated surgical device used by physicians.

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

The "ground truth" for the regulatory submission is based on the established safety and effectiveness of the predicate devices already on the market. The submission asserts that the new device has "similar basic features and intended uses" to these predicates and "raise no new issues of safety and effectiveness."

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a surgical instrument.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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Providing thorough irrigation and aspiration of the peritoneal cavity.Bleeders can be identified,bile,stones,tissue,blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry.

Sole purpose of these instruments are to move tissue around. Sole purpose of these instrain by means of grasping any body They can not grasp or restrain by addints the body cavity They can not grasp of resorain by de into the body cavity organ or tissue. They are introduced they can only move through a brood trough the or up and down.

Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs.

Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures.

Verres needles puncture through the abdominal wall to enable verres needies puncture theabdominal cavity creating space the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity.

Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired.

Instruments which permit the grasping and manipulation of the country the countancel covity enableing a surgeon Instruments which the pritoneal cavity enableing a surgeon needles inside the peritoneal cavity enableing a surgeon needles inside the periconeal cavily charoscopic procedures.

Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy,cut,coagulate,manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.

Trocar and Trocar Sleeves, Laparoscopes, Laparoscopic Forceps and Laparoscopic Instruments, FAN RETRACTORS AND FINGER DISSECTORS, TROCARS, TROCAR SLEEVES AND DILATORS, VERRES NEEDLES, KNOT PUSHER, NEEDLE HOLDERS, MONOPOLAR ELECTRODES,CAUTERY FORCERS,BIPOLAR FORCEPS & SCISSORS AND NON-CAUTERY FORCEPS

This document is a 510(k) premarket notification from the FDA for various laparoscopic instruments manufactured by Jakoubek Medizintechnik GmbH. The document is primarily focused on establishing substantial equivalence to existing devices and outlines the indications for use of several instruments. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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The Olympus "Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic applications.

Trocar System according to Hasson. Common/Usual Name: Trocar, blunt and cone for laparoscopic application.

This document is a 510(k) summary for the Olympus Trocar System according to Hasson. It states that the device is substantially equivalent to predicate devices for its intended use, which is for "first puncture technique according to Hasson in laparoscopic application."

Based on the provided text, there is no acceptance criteria or study information that would allow me to populate the table or answer the specific questions about device performance, sample sizes, ground truth, or expert involvement.

The 510(k) process for this type of device (a Class II surgical instrument) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria directly related to performance metrics like sensitivity, specificity, or reader improvement. The focus is on demonstrating that the new device is as safe and effective as the predicate device.

Therefore, the table and answers below reflect the absence of this information in the provided document.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on provided text):

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not Applicable. The document does not describe a clinical "test set" or a performance study with human subjects or data in the way an AI/diagnostic device would. The 510(k) process for this device relies on a demonstration of substantial equivalence to predicate devices, not on a new clinical study with a test set.

2. 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):

   • Not Applicable. As no specific "test set" or ground truth establishment relevant to an AI or diagnostic claim is described, expert involvement for this purpose is not mentioned. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the experts who evaluated the submission for substantial equivalence.

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

   • Not Applicable. No test set or adjudication method for clinical performance is described.

4. 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 device is a surgical instrument (trocar system), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • Not Applicable. This device is a manual surgical instrument; it is not an AI algorithm, and therefore, a standalone algorithm performance study is irrelevant and was not performed.

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

   • Not Applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI systems is not relevant here. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the Olympus Trocar System is being compared, assuming those predicates were legally marketed.

7. The sample size for the training set:

   • Not Applicable. As this is not an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. No training set exists for this device.

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