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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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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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The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.

The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.

This document is a 510(k) premarket notification for an Endoscopic Injection Needle. The device is an accessory for endoscopes used to deliver injectable materials into tissue during endoscopic procedures. The notification concludes that the device is substantially equivalent to a predicate device (Carbon Medical Technologies Endoscopic Injection Needle K042615).

Based on the provided information, there is no study proving the device meets specific acceptance criteria in the sense of an effectiveness or performance study with a numerical outcome on efficacy, sensitivity, specificity, etc. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, risk assessment (FMEA), and various validation and testing activities related to manufacturing and safety.

Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission for this particular device. This 510(k) is for a Class II endoscope accessory, and the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy.

However, based on the technological characteristics and performance section, we can infer the "acceptance criteria" and "study" are related to manufacturing, safety, and equivalence to the predicate.

Here's an attempt to answer the questions based on the available information:

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)

• Sample Size for Test Set: Not explicitly stated. The document refers to "validation" and "testing" (e.g., sterilization validation, functional testing), which would involve samples, but the specific number of units tested is not provided in this summary.
• Data Provenance: Not specified, but likely from in-house lab testing and potentially third-party testing facilities engaged by Carbon Medical Technologies, Inc. It's a technical submission, not a clinical study involving patients, so "country of origin for clinical data" is not relevant here. The studies mentioned (e.g., sterilization, shelf life) are prospective laboratory/engineering 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 submission does not involve clinical "ground truth" derived from expert interpretation of medical data (like images or pathology). The "ground truth" for these tests are objective measurements and established standards for engineering, manufacturing, and safety (e.g., sterility, material properties, functional integrity).

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

• Not Applicable. This is not a clinical study involving subjective interpretation that would require adjudication. The "tests" are objective and based on established protocols and standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is completely irrelevant for this device. This is a physical medical device (an injection needle), not an AI-powered diagnostic or assistive tool.

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

• No. This is not an algorithm or AI device.

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

• For the validation and testing mentioned, the "ground truth" is based on:
  • Established scientific and engineering principles: (e.g., for functional testing, material properties).
  • Regulatory standards and guidelines: (e.g., for sterilization, biocompatibility, EO residuals, packaging).
  • Predicate device characteristics: For demonstrating technological equivalence.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. This is not a machine learning or AI device.

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The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure

The Carbon Medical Technologies Endoscopic Injection Needle consists of a stainless steel needle attached to a plastic insertion tube. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the proximal end of the device, is designed to accommodate a standard syringe.

The CMT Endoscopic Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of injectable bulking agent during endoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures.

The CMT Endoscopic Injection Needle is provided sterile and is intended for single use only.

This looks like a 510(k) premarket notification for a medical device. The provided text describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone). This type of detailed study data is typically found in the clinical or non-clinical performance sections of a 510(k) submission, which are not present in the excerpt.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them based on the given input.

Based on the provided text, I can only state the following:

• Device Name: Carbon Medical Technologies Endoscopic Injection Needle
• Intended Use: An accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
• Basis for Clearance: Substantial equivalence to predicate devices (Scerotherapy Needle - Medi-Glove (K955558) and CMT Endoscopic Injection Needle - Carbon Medical Technologies, Inc. (K982890)). The substantial equivalence was based on "design, materials, methods of fabrication and indications for use."

To answer your request, I would need additional sections of the 510(k) submission that detail performance testing and clinical evaluations, if any were required for this type of device.

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The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.

The Martech Endoscopic Injection Needle fits within various endoscopes with working channels having a 5 French or larger inner diameter and extends beyond the proximal end of the endoscope. The Endoscopic Injection Needle is sterile, disposable and nonpyrogenic. It consists of a non-coring, 23 gauge stainless steel needle attached to a flexibe, 5 French polycarbonate catheter with luer lock hub. The luer lock hubs are designed to meet the "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983). Moreover, these luer lock hubs are designed to accommodate standard syringes. To allow for smooth passage of the device through the endoscope's instrument channel, the transition between the needle and catheter assembly is tapered.

The Endoscopic Injection Needle will be provided in a variety of lengths, up to 200 cm, in order to accommodate for different length instrument channels. The needle length will be specified on the device's unit label. In general, the shorter needles with shorter endoscopes such as bronchoscopes and the longer needles may be used with longer endoscopes such as flexible gastroscopes and colonoscopes.

This is a 510(k) summary for a medical device (Martech Endoscopic Injection Needle), not a study analyzing AI/algorithm performance. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc. related to AI or algorithm performance) is not applicable and cannot be extracted from this document.

The document describes the device, its intended use, and claims substantial equivalence to predicate devices (Bard Endoscopic Injection Needle and Mill-Rose Endoscopic Injection Needle).

Here's what can be extracted based on the nature of the document:

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

• Acceptance Criteria for the device itself (not an AI/algorithm): The document implies performance criteria related to its physical characteristics and functionality. These are not explicitly stated in a quantitative table but are inferred from the description and comparison to predicate devices.
  • Fits within various endoscopes with working channels having a 5 French or larger inner diameter.
  • Extends beyond the proximal end of the endoscope.
  • Sterile.
  • Disposable.
  • Nonpyrogenic.
  • Non-coring, 23 gauge stainless steel needle.
  • Flexible, 5 French polycarbonate catheter with luer lock hub.
  • Luer lock hubs meet "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983).
  • Luer lock hubs accommodate standard syringes.
  • Tapered transition between needle and catheter assembly for smooth passage.
  • Available in various lengths up to 200 cm.
• Reported Device Performance (as implied by the 510(k) summary): The document asserts that the device meets these implied criteria by claiming substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for these functions. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. There are no specific quantitative performance metrics reported in this summary that would typically be found in an algorithm performance study (e.g., sensitivity, specificity, accuracy).

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

• Not applicable. This is not an AI/algorithm performance study. The 510(k) summary does not detail a "test set" in this context.

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 is not an AI/algorithm performance study.

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

• Not applicable. This is not an AI/algorithm performance study.

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/algorithm performance study.

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

• Not applicable. This is not an AI/algorithm performance study; it's a physical medical device.

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

• Not applicable in the context of an algorithm. The "ground truth" for this device's safety and effectiveness is established through adherence to standards (ANSI/HIMA MD70. i-1983) and comparison to predicate devices for which safe and effective use has already been demonstrated in clinical practice.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm development.

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

• Not applicable. This is not an AI/algorithm development.

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