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EzVu Visual Vasopressor Injector (EV-19) is intended to inject vasopressor solution into the uterine musculature during laparoscopic surgery.

EzVu Visual Vasopressor Injector (EV-19) is a 330 mm long and 5 mm diameter hollow bore laparoscopic instrument, used to enable laparoscopic flashback visualization before injecting Vasopressor drug into the uterine musculature during laparoscopic surgery. It consists of a stainless steel needle at the distal end, securely connected to a hub, an elongated shaft with transparent window at the distal end and stopcock with luer connection at the proximal end onto which a syringe can be attached. The shaft is made of transparent plastic tube, surrounded by a stainless steel tube along the proximal portion of the injector to provide stability. The stainless steel tube around the transparent plastic tube is wrapped in a heat shrink. The injector is available in one needle size (19 gauge).

Here's a breakdown of the acceptance criteria and the study details for the EzVu Visual Vasopressor Injector (EV-19), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Secondary Endpoint:

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

• Sample Size:
  • Clinical Study (Patients): 13 women
  • Injections: 24 injections across the 13 patients.
  • Blood Aspiration Cases: 25 cases (Note: this number is slightly different from the 24 injections mentioned earlier in the text for detection of blood aspirate).
• Data Provenance: The study was a "multi-center, prospective observational study." The country of origin is not explicitly stated, but the sponsor is located in Navi Mumbai, Maharashtra, India.

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

• Number of Experts: 5
• Qualifications: "trained laparoscopic gynecological surgeons"

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the clinical study's primary and secondary endpoints. It appears that the observations (visibility of blood aspirate, leakage/breakage, compatibility, and usability ratings) were collected directly from the surgical procedures and surgeon feedback.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there any mention of AI assistance or its effect size on human readers. This device is a physical injector, not an AI-powered diagnostic tool.

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

This question is not applicable. The EzVu Visual Vasopressor Injector is a physical medical device, not an algorithm, and does not operate without human interaction. Its performance is intrinsically linked to its use by a surgeon.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through direct observation during surgical procedures by trained laparoscopic gynecological surgeons and their subjective feedback via Likert scales for usability. For the primary endpoint, it was the actual presence/absence of blood aspirate and device integrity as observed by the surgeon, and for the secondary endpoint, it was the surgeons' qualitative assessment of performance and compatibility.

8. The Sample Size for the Training Set

The document does not mention a training set, as this is a physical medical device and not an AI/machine learning algorithm that requires a training phase. The described studies are for validation of the fully developed device.

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

This question is not applicable, as there is no mention of a training set for this device.

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It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.

The provided document is a 510(k) summary for the "Endoscopic Injection Needles" (K240675) from Promisemed Hangzhou Meditech Co., Ltd. It focuses on demonstrating substantial equivalence to a predicate device (Single Use Injection Needle, K210917) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical targets and results in the format requested. Instead, it lists the performance items tested and concludes that the testing "successfully demonstrated essential performance" and that the device "is at least equivalent to the predicate device."

Here's a breakdown of the tested performance items:

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

The document
does not specify the sample sizes
used for each individual non-clinical performance test. It only states that "Performance testing was conducted."

Regarding data provenance, the document indicates that Promisemed Hangzhou Meditech Co., Ltd. is the manufacturer, located in Hangzhou City, China. The biocompatibility testing was conducted by a "third GLP laboratory," but its location is not specified. All tests described are retrospective in the sense that they were conducted for the purpose of this 510(k) submission, likely in a controlled laboratory environment.

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

This information is not applicable as the provided document details non-clinical, benchtop performance testing, not studies involving human subjects or expert assessment of clinical data to establish a "ground truth" as might be done for diagnostic devices. The acceptance criteria for these tests are based on established engineering standards and specifications rather than expert consensus on medical conditions.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Benchtop performance tests typically involve objective measurements against predefined specifications, not subjective assessments requiring adjudication among experts.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test is included in this submission." and "No reference devices were used in this submission." This type of study is relevant for diagnostic imaging devices where human interpretation is involved.

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

No, a standalone algorithm performance study was not done. This device is an Endoscopic Injection Needle, a physical medical instrument, not a software algorithm. Therefore, the concept of "standalone algorithm performance" (without human intervention) is not applicable.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests described is based on:

• Engineering specifications and design requirements for the device.
• Established national and international standards for medical device testing (e.g., ISO 11135, AAMI/ANSI/ISO 10993-7, ASTM F1980-16, ISO 11607-1, ISO 11607-2, ISO 10993 series, USP ).
• Comparison to the predicate device's performance characteristics to establish substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. As this is a physical medical device and not a machine learning or AI-driven system, there is no "training set." The device's design is based on engineering principles and prior knowledge.

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

This information is not applicable for the same reason as point 8.

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The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues of structures during cystoscopic procedures. They are provided sterile for single use only.
The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly depending on the skill of surgeon.
The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the needle dependent upon the type of procedure. The intended use does not vary based on the model number or difference in measurement specifications.
The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

This document is a 510(k) summary for a medical device called "injeTAK Adjustable Tip Needle (DIS199; DIS201)". The FDA's substantial equivalence determination process for 510(k) clearances typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves non-clinical testing to compare the new device's performance against its design specifications and, by extension, against the predicate.

Given this context, the document primarily focuses on non-clinical testing and comparisons to a predicate device, rather than a clinical study evaluating an AI algorithm or human-in-the-loop performance.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical tests performed to ensure the device meets its design specifications and performs as intended. Specific, quantifiable acceptance criteria are not explicitly listed in a table format within the provided text, but the general outcome for each test is stated. The "acceptance criteria" are implied by the statement "passed all requirements" or "met the acceptance criteria."

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

The document does not specify exact sample sizes for the non-clinical tests conducted (e.g., how many needles were tested for biocompatibility, packaging, or functional performance). It mentions "the product's packaging testing" and "the testing performed," implying a set of samples were used for each test.

Data Provenance: The tests are described as non-clinical and in-house/manufacturer-conducted tests to verify product design specifications. The data is internal to Laborie Medical Technologies Corp.

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 an invasive medical instrument (needle) and the evaluation presented is a non-clinical device verification and validation summary, not an AI/software product requiring expert ground truth for interpretation of images or other data. The "ground truth" here is the device's adherence to its engineering specifications and relevant ISO standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human assessment of data that would require an adjudication method. The "adjudication" in this context would be the internal quality and regulatory review process of the manufacturer.

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 not an AI-assisted diagnostic or predictive device, and no MRMC study was conducted or is relevant to this submission.

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

No. This is a hardware device (needle), not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device's performance evaluation is based on:

• Engineering Design Specifications: The device must meet its predefined critical dimensions, functional parameters (e.g., flow rate, luer leak), and material properties.
• International Standards: Adherence to relevant ISO standards for biocompatibility (e.g., ISO 10993 series), sterilization (e.g., ISO 11135, ISO 11137), and packaging (e.g., ISO 11607).
• Predicate Device Performance: Demonstrating that the new device performs at least as well as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm.

The device is sterilized by ethylene oxide. The shelf life is 3 years.

The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

This is a 510(k) premarket notification for a medical device (Disposable Injection Needles), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than complex performance criteria for AI/ML devices. Therefore, many of the requested categories for AI/ML device performance are not applicable to this submission.

Based on the provided document, here's an analysis of the acceptance criteria and supporting studies:

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

The document does not present a formal table of "acceptance criteria" in the way one might expect for a digital health or AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with established medical device standards and demonstrating performance comparable to the predicate device. The Reported Device Performance is stated as meeting the requirements of these standards.

The document concludes that "The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914)." This general statement serves as the overall reported device performance and proof that it meets the implicit acceptance criteria of substantial equivalence.

The following information is not applicable to this traditional medical device submission, as it pertains to AI/ML device evaluations:

2. Sample size used for the test set and the data provenance: Not applicable. The tests are physical and chemical bench tests on the device materials and functional aspects, not AI performance on data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device often involves expert annotation. For this physical device, "ground truth" is measured by adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For this device, the "ground truth" is adherence to performance specifications outlined in the referenced ISO and ASTM standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.

The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.

The information provided is about the substantial equivalence of the STERIS Articulator and Carr-Locke Injection Needles (K232826) to a predicate device. This document is a 510(k) summary, which focuses on comparing a new device to a legally marketed predicate device to demonstrate that it is as safe and effective. It does not describe a study involving algorithms, AI, or human reader performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth used, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and device performance from the tables in the "Summary of Nonclinical Tests" section.

Acceptance Criteria and Device Performance

The STERIS Articulator and Carr-Locke Injection Needles (K232826) underwent nonclinical testing to demonstrate substantial equivalence to the predicate device. The following table summarizes the acceptance criteria and reported results:

Study Information (Relevant to this type of device)

1. Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices or tests performed) for each nonclinical test. It only states that testing was performed. Data provenance is not described as this is a device performance study, not a clinical trial or AI model validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests are engineering/performance evaluations, not clinical diagnoses requiring expert ground truth.
3. Adjudication method for the test set: Not applicable for nonclinical device performance tests.
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: Not applicable. This is not an AI/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
6. The type of ground truth used: For these nonclinical tests, the "ground truth" is defined by the "design requirements" which are established engineering and performance specifications for the device.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

The provided text is a 510(k) summary for the Disposable Endoscope Injection Needles. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Device Description: What the device is made of and its configurations.
• Intended Use: How the device is meant to be used.
• Comparison of Technological Characteristics: A table comparing features of the proposed device to a predicate device.
• Non-clinical Performance Data: Mentions conformity to ISO standards for biocompatibility and sterilization, and some bench tests (appearance, physical properties) that "passed."
• Clinical Test Data: Explicitly states, "No Clinical Study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because these aspects are relevant to AI/ML device evaluations and are not present in this 510(k) for a conventional medical device.

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The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.

The Disposable Injection Needle has different model specifications depending on different working length and the needle size.

This document is a 510(k) summary for a Disposable Injection Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a complex AI/software-driven medical device. Therefore, the requested information, which pertains to such a study (sample sizes, expert adjudication, MRMC studies, ground truth establishment for AI/ML models), is not present in the provided text.

The document discusses non-clinical bench testing to demonstrate that the Disposable Injection Needle meets design specifications and performs comparably to a predicate device. This is a physical device, not an AI/ML-driven one.

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 document doesn't provide a direct "acceptance criteria" table in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it lists various physical and chemical performance tests for the medical device. The "acceptance criteria" for these tests would be meeting the specified thresholds or demonstrating equivalence to the predicate device. The "reported device performance" is that the tests were carried out and demonstrated substantial equivalence.

Non-Clinical Performance Tests Performed:

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

• Sample Size: Not explicitly stated for specific tests. The document mentions tests were performed on "both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle)." It doesn't specify the number of units tested for each.
• Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the results of bench testing. There is no mention of country of origin of data, nor whether it's retrospective or prospective, as these terms apply to clinical studies.

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. This device is a physical medical instrument, not an AI/ML system that requires expert annotation for ground truth. The "ground truth" for these tests would be established by validated test methods and reference standards.

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

Not applicable. This is not a study involving human readers or interpretation.

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-assisted device. The document explicitly states: "N/A, no clinical studies are available for the subject device."

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

Not applicable. This is not an algorithm.

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

The ground truth for this device's performance is based on established engineering and materials testing standards (e.g., ISO, ASTM, USP) and the performance of the legally marketed predicate device. For example, for biocompatibility, the ground truth is compliance with ISO 10993. For mechanical performance, it's demonstrating equivalence to the predicate and meeting specified functional requirements.

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.

In summary: The provided FDA 510(k) summary is for a physical medical device (Disposable Injection Needle) and demonstrates substantial equivalence through non-clinical bench testing against a predicate device and adherence to recognized standards. It does not contain the information requested regarding AI/ML device performance studies, as those types of studies (MRMC, standalone algorithm performance, expert adjudication, ground truth for training/test sets) are not relevant to this specific device submission.

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Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.

All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.

There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).

The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.

These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.

There are no accessories for this kind of devices.

This document describes the G-Flex Europe SPRL's Sclerotherapy & Endoscopic Needles, which are endoscopic accessories intended to introduce sclerosing agents or other solutions into the digestive system. The 510(k) submission, K222006, establishes substantial equivalence to the Boston Scientific Interject Injection Therapy Needle Catheter (K171454).

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

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

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied to be that the device performs comparably to the predicate and meets design specifications and relevant standards.

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

The document explicitly states: "No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical "test set" in the context of human data. The performance evaluations were based on non-clinical bench testing, biocompatibility testing, sterility validation, and shelf-life studies. The "sample sizes" for these non-clinical tests are not detailed in the summary, nor is the "data provenance" (country of origin), as it pertains to laboratory and manufacturing data rather than patient data.

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

Given that no clinical testing was performed and no "test set" of patient data was used, this information is not applicable.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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 device is a physical endoscopic accessory, not an AI-assisted diagnostic or treatment system involving human readers.

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

Not applicable. The device is a physical endoscopic accessory, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by:

• Design Specifications: For bench testing, comparing physical and mechanical characteristics to engineering and design requirements.
• International Standards: For biocompatibility (ISO 10993 series), sterility (ISO 11135-1:2014, ISO 11138-2:2009), packaging (ISO 11607-1:2019), and aging (ASTM F1980-16, ASTM D4169-16). Compliance with these standards serves as the ground truth for safety and performance in their respective domains.
• Predicate Device Characteristics: For the substantial equivalence comparison, the characteristics and established safety/effectiveness of the predicate device (Boston Scientific Interject Injection Therapy Needle Catheter, K171454) served as the "ground truth" baseline.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI models with 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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The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided document describes the non-clinical performance testing for the CORE-INJECTOR device to demonstrate its substantial equivalence to a predicate device. It does not contain information about a comparative effectiveness study (MRMC) or a standalone (algorithm-only) study for a medical imaging AI device. The device in question is an endoscope injection needle, not an AI or imaging device. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.

The provided text does not describe an AI/ML device, therefore, the requested information focusing on acceptance criteria and studies for such devices, including details like test set provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set specifics, is not applicable.

The document discusses the substantial equivalence of a medical device, the LiNA OperaScope™ Needle, to a predicate device (Cook Injection Needles). The acceptance criteria and supporting studies are related to the physical performance, biocompatibility, and shelf-life of this non-AI medical instrument.

Here's the relevant information based on the provided text, adapted to the context of a physical medical device:

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

8. The sample size for the training set

Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for a physical medical instrument.

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

Not applicable, as this is a non-AI/ML device.

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