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The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The provided FDA 510(k) summary (K241022) for the Sterile single use tip cleaner (WK800-S10, WK800-S20) does not contain information on how the acceptance criteria were established or details of a study that proves the device meets specific performance criteria related to clinical efficacy.

The document focuses on non-clinical performance testing for physical characteristics and manufacturing-related residuals, primarily to establish substantial equivalence to a predicate device. There is no mention of clinical studies, human reader performance, AI assistance, or related metrics.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: These acceptance criteria are for non-clinical, physical, and manufacturing characteristics, not for clinical performance or diagnostic accuracy.

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

The document specifies "Non-clinical Performance Testing" but does not provide details on the sample size for these tests (e.g., how many units were tested for peel strength or appearance). It also does not mention the data provenance beyond it being conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. in China. Given the nature of these tests, they would be prospective manufacturing quality and material property tests.

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 tests performed are non-clinical, evaluating physical properties and chemical residuals, not requiring expert clinical interpretation or ground truth establishment in the way a diagnostic imaging device would.

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

Not applicable. This is not a study involving human interpretation or adjudication. The results are from physical measurements and observations against defined specifications.

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 device is a sterile single-use tip cleaner, an accessory for electrosurgical cauterization. It is a physical medical device, not an AI or software-driven diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.

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

No. As explained above, this device is not an AI algorithm. The performance tests are for its physical properties and sterility.

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

For the non-clinical tests, the "ground truth" or reference is the predefined technical specifications and standards (e.g., "free from damage, cracking," "peel strength ≥ 2N/CM," "FTO Residual ≤ 4mg/pcs"). These are established engineering and quality control criteria.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

Not applicable, for the same reasons above.

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The Specimen Bag is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.

The provided text is a 510(k) Pre-Market Notification for a medical device (Specimen Bag models), indicating it is seeking substantial equivalence to a predicate device. This document primarily details the device's intended use, description, and comparison to the predicate device, along with the non-clinical tests performed.

However, the provided text does not contain information about a study that proves a device meets acceptance criteria related to an AI/Machine Learning algorithm's performance, nor does it provide the detailed breakdown requested regarding acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC).

The "tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses" (page 5) refer to a series of engineering and biocompatibility tests typical for a physical medical device, not an AI/ML algorithm. These tests include:

• Tensile strength
• Bag load-bearing
• Opening force
• Rope tension test
• Puncture Force Test
• Pouch Leakage Test
• Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity)

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document. The device is a "Specimen Bag," a physical medical device, not an AI/ML-driven diagnostic or assistive tool.

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The Equipment Pouch is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Equipment Pouch is a sterile and single-use specimencontainer designed for use in retrieving specimens during endoscopic surgery. The Equipment Pouch is supplied in a dispending tube for ease of insertion through a standard 10, 11, or 12mm trocar sheath.

The provided text describes a 510(k) premarket notification for a medical device called "Equipment Pouch". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical effectiveness. Therefore, the information provided does not pertain to studies typically conducted for AI-powered devices or diagnostic tools that require a deep analysis of performance criteria against expert-established ground truth or clinical outcomes.

The testing described is primarily non-clinical bench testing to assess the physical performance and biocompatibility of the device, which is a sterile surgical pouch. There is no mention of a study involving human readers, AI assistance, or complex diagnostic tasks.

Given this context, I will address your specific points based on the available information, noting when information is not applicable or not provided in the document.

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

The document lists non-clinical (bench) tests and states that the device 'meets the requirements of its pre-defined acceptance criteria and intended uses.' However, the specific numerical acceptance criteria and the exact reported performance values for each test are not quantitatively detailed in this summary. Instead, a qualitative description of what each test demonstrates is given.

Biocompatibility tests (ISO 10993 series) were performed, and the document implies they met acceptance criteria, but specific results or quantitative criteria are not listed here.

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 or not provided for this type of device and testing. The tests are benchtop physical and chemical tests of the device itself, not studies on a patient population with specific data provenance.

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 or not provided. The 'ground truth' for these tests relates to engineering specifications (e.g., a bag holding 1kg, a rope withstanding 2kg), not clinical diagnoses or expert interpretations of images.

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

This information is not applicable or not provided. Adjudication methods are relevant for studies involving human interpretation (e.g., reviewing medical images), which is not the nature of the testing described here.

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 device is a surgical pouch, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this device.

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

This information is not applicable. This device does not involve an algorithm. The "performance" refers to the physical characteristics of the pouch.

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

The "ground truth" for the non-clinical testing described is based on engineering specifications and direct measurements of physical properties (e.g., weight capacity, tensile strength, leak integrity) as well as the results of standardized biocompatibility tests. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

This information is not applicable. As there is no training set (for AI), there is no ground truth established for one. The "ground truth" for the device's design and testing is based on established engineering principles and medical device standards.

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The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.

The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.

The provided document is a 510(k) summary for a medical device called "Suction Irrigation Set". This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a robust clinical setting.

Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets them, especially in the context of AI/ML or diagnostic performance, is not available in this document. The tests described are primarily non-clinical, focusing on safety and functional equivalence to a predicate device.

However, I can extract the available information regarding the non-clinical testing performed and the general statement about meeting acceptance criteria.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Available: The document states that "All the test results demonstrate the performance of Suction Irrigation set meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical acceptance criteria and the quantitative reported performance for each test are not provided. Only the types of tests are listed.

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

• Not available in explicit detail. The document mentions "A series of tests" but does not specify sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for these non-clinical, bench-level tests.

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

• Not applicable/Not available. These are non-clinical, engineering/materials tests. There is no "ground truth" established by human experts in the context of a diagnostic or interpretative device.

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

• Not applicable/Not available. Adjudication methods are relevant for expert-driven diagnostic assessments, not for the physical/chemical tests 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 manual suction irrigation set, not an AI/ML-powered diagnostic or assistive device for human readers.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. For the physical/chemical tests conducted, the "ground truth" would be established by objective measurements against engineering specifications and industry standards (e.g., ISO for sterilization).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

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

• Not applicable. This device does not involve a "training set."

In summary: The provided document is a regulatory submission for a traditional Class II medical device, demonstrating substantial equivalence through non-clinical testing. It does not contain information typically found in studies for AI/ML or diagnostic devices, which involve clinical performance and human reader assessment.

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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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The 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 Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

This document is a 510(k) summary for the WickiMed Veress Needle and provides information on its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, therefore no information about acceptance criteria and studies proving the device meets these criteria as would be relevant for an AI/ML system is available.

The document discusses the following types of non-clinical testing for the Veress Needle:

• Biocompatibility tests: Conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. These included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Material-Mediated Pyrogenicity.
• Sterilization validation: Performed per ISO 11135:2014.
• Performance tests:
  • Tip Pull Test
  • Switch Operation
  • Spring Obturator Operation
  • Needle Puncture Force Test

The document states that "All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide the specific numerical acceptance criteria for these tests, nor the reported device performance values. It also does not discuss any of the other specific items from your request (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) as these are not relevant to a traditional medical device submission like a Veress Needle.

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