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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 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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The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.

The devices in the KARL STORZ Suction and Irrigation System are manually operated, reusable surgical devices consisting of handle, suction/irrigation tubes, cannulae or needles. The handle is intended to be used in combination with suction/irrigation cannulae and tubing and controls the suction and irrigation. Enabled by the handle with stop cock valve, the regulation of the irrigated quantity of fluids via the tubes, or rather the quantity of aspirated fluid (e.g., blood, fluids, and tissue debris) into or out of the patient is performed. Cannula and needle: Enabled by the pointed distal end, both puncture and injection/extraction cannulae and needles, perform puncturing of target organs or tissues and injecting fluids into operating site i.e. extracting blood or fluids from them. The prerequisite for suction is either a vacuum powered suction wall apparatus or a pump, which serve as impulse for the suction. The proximal end of the tube set is connected to the vacuum or pump. Either a pump is required as impulse for irrigation or the natural force of gravity, i.e., by positioning the flush bag at the appropriate height.

The provided document is an FDA 510(k) Premarket Notification for medical devices, specifically KARL STORZ suction and irrigation systems. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data and does not typically include studies involving artificial intelligence (AI) or machine learning (ML) components, nor does it present "acceptance criteria" and "device performance" in the context of an AI/ML model's diagnostic or predictive capabilities.

Therefore, the requested information regarding AI/ML-related acceptance criteria and study details (such as sample sizes for test and training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment, etc.) cannot be extracted from this document, as it is not relevant to the type of device and submission described.

The document focuses on:

• Device Description: Manually operated, reusable surgical devices (handle, suction/irrigation tubes, cannulae, needles).
• Intended Use: Suction and/or irrigation to flush or remove blood, fluids, and tissue debris during laparoscopic surgical procedures.
• Basis for Substantial Equivalence: Comparison to predicate KARL STORZ devices (K945059 and K951190) based on technological characteristics and non-clinical performance data.
• Non-Clinical Performance Data Provided:
  • Biocompatibility testing: Compliance with ISO 10993.
  • Reprocessing Validation: Compliance with standards like ANSI/AAMI/ISO 14937, 11138-3, 11607-1, 11737-1, 17664, 17665-1 regarding cleaning and sterilization.
  • Bench Top Performance Testing: Leak Test, Flow Incoming Test, Flow Outgoing Test.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

In summary, this document does not contain information about an AI/ML device or its associated performance studies.

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The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
• introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;
• aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
• control non-variceal hemorrhage.

The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.

The provided text is a 510(k) summary for a medical device called the "Disposable Endoscope Injection Needle." It describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, it explicitly states that "No Clinical Study is included in this submission."

Therefore, I cannot provide information about acceptance criteria and a study that proves the device meets clinical performance acceptance criteria, as no such clinical study was conducted or presented in this document. The submission relies solely on non-clinical (bench) testing and substantial equivalence to a predicate device.

Here's what I can extract regarding acceptance criteria and performance based only on the non-clinical data provided:

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

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 does not specify the sample sizes used for the non-clinical (bench) tests. The data provenance is implied to be from Yangzhou Fartley Medical Instrument Technology Co., Ltd. in China, where the device is manufactured. These are all prospective bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These were non-clinical, objective bench tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as these were objective bench tests, not subjective interpretations requiring adjudication.

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 physical medical instrument (an injection needle), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" was defined by engineering specifications, industrial standards (like ISO 10993, ISO 11135), and the physical properties required for safe and effective function of such a device.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable.

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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 injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.

The provided text is a 510(k) summary for an Injection Needle, a medical device used with an endoscope for various injections in the GI tract. It does not describe an AI/ML-enabled device nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the new Injection Needle to a predicate device (Single Use Injector NM600/610) based on non-clinical tests (biocompatibility, sterility, package integrity, etc.) and direct comparison of design and intended use specifications, as is common for traditional medical devices in a 510(k) submission. No clinical study was performed.

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Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.

The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.

The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.

The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.

The provided text describes the Endoscopic Injection Needle (K213239) and its acceptance criteria, along with a summary of the testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the tests listed. The "Reported Device Performance" column indicates that the device met these criteria through successful testing.

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

• Test Set Sample Size: The document does not explicitly state the sample size used for each specific bench test item. It generally refers to "bench testing" being performed.
• Data Provenance: The data is from "Summary of non-clinical and performance testing- Bench testing" carried out by Beijing ZKSK Technology Co., Ltd. The tests were performed according to recognized consensus standards and the company's technical requirements. This is retrospective testing performed by the manufacturer on its own device prototypes/production samples. The country of origin for the testing is implied to be China, where the manufacturer is located.

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

Not applicable. This device is a physical medical instrument, not an AI/software device that relies on expert interpretation for ground truth in its performance evaluation as described in the context of AI/ML devices. The "ground truth" for the bench tests is based on objective measurements and adherence to engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring human adjudication for performance evaluation. Adjudication methods are typically relevant for subjective expert assessments or when there are disagreements in interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an Endoscopic Injection Needle, a physical instrument, and its evaluation focuses on bench testing and mechanical/biocompatibility performance, not on AI-assisted human reading.

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; it's a physical medical instrument. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on objective measurements, adherence to recognized consensus standards (e.g., ISO 7864, ISO 9626, ISO 10993 series, ISO 11607-1, ISO 80369-7), and the manufacturer's internal design requirements and specifications. For biocompatibility, the ground truth is established by the biological responses observed against the criteria in ISO 10993.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device's safety and effectiveness are established through physical and biological testing as described above.

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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Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected 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 Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.

The provided document is a 510(k) Summary for a Single Use Injection Needle, which is a medical device, not an AI/ML software. Therefore, the questions related to AI/ML software performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission.

The document describes the non-clinical performance testing conducted to demonstrate the essential performance of the proposed device and confirm it works as intended and is substantially equivalent to a predicate device.

Here's the information extracted from the document regarding the acceptance criteria and study proving 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" side-by-side with "reported device performance" in the format typically seen for AI/ML models (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests conducted and concludes that the results demonstrated substantial equivalence. The predicate device's characteristics serve as the de-facto acceptance criteria for equivalence.

Here's a summary of the non-clinical performance tests and the conclusion of equivalence:

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