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The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:

• NA-201SX-4021:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.9mm
• Needle Width: 21G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

• NA-201SX-4022:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.8mm
• Needle Width: 22G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

Both models feature an adjustable sheath length and are intended for single use.

This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.

The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.

Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.

Acceptance Criteria and Reported Device Performance (Physical Device)

This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/SaMD specific questions:

As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
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 a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
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. This applies to AI-assisted diagnostic or interpretive systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
8. The sample size for the training set: Not applicable. This applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable. This applies to machine learning models.

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This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement. The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.

This submission (K190239) is for a medical device (Single Use Aspiration Needle NA-U401SX-4025N, also known as ViziShot 2), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and adjudication methods are not applicable to the provided document.

The document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

• Accelerated aging test conducted per ASTM F1980-16 for sterile barrier systems.
• Real-time aging test for three years will be performed to
  demonstrate longer stability and support accelerated aging test results. |
  | Biocompatibility | Device materials are biocompatible and do not pose unacceptable biological risks. | - Biocompatibility testing conducted per FDA's "Use of International Standard ISO 10993-1:2009, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'."
• Specific tests completed: Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Pyrogen Study. |
  | Performance - Bench | Device functions as intended and meets design specifications for aspiration, piercing, visibility, etc. | - Bench testing conducted to ensure devices perform as intended and meet design specifications.
• Specific tests performed: Piercing, Ultrasound visibility, Needle extraction and retraction, Aspiration, Endoscope compatibility, Handle function, Joint Pull Strength, Breakage Strength.
• "Bench testing confirms that the NA-U401SX-4025N meets its essential performances, which are technologically equivalent to those of the reference device." |
  | Risk Analysis | Identified risks are mitigated adequately and meet established in-house acceptance criteria based on ISO 14971:2007. | - Risk analysis conducted in accordance with ISO 14971:2007.
• Design verification tests and their acceptance criteria were identified and performed based on this assessment. |

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

• Sample Size: Not specified in the document. The document refers to "bench testing," "accelerated aging test," and "biocompatibility testing," which inherently involve testing a certain number of devices or samples.
• Data Provenance: The tests were conducted internally by Olympus ("established in-house acceptance criteria"). The country of origin of the data is not explicitly stated, but the submitter is Olympus Medical Systems Corp. in Tokyo, Japan. The tests are non-clinical (bench, lab-based), so retrospective or prospective doesn't directly apply in the same way it would for clinical data.

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

• Not applicable as this is not an AI/ML device dealing with "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance tests would be the established engineering and biological standards and specifications the device is designed to meet.

4. Adjudication method for the test set

• Not applicable. This is not an AI/ML device involving human interpretation and 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 not an AI product.

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

• Not applicable. This device is not an AI product.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on engineering specifications, established medical device performance standards (e.g., sterilization, biocompatibility, mechanical strength), and a risk analysis based on ISO 14971:2007. It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the AI/ML sense.

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

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

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This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract.

The Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement. The subject devices will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.

This is a submission for a medical device called the "Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N". This document is a 510(k) summary, which means it's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance results for each criterion in a summarized format. Instead, it lists the types of performance data collected and states that these tests were conducted "to ensure that the subject devices perform as intended and meet design specifications." The overall conclusion is that the device "raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance."

Based on the "Performance testing - Bench" section, we can infer some of the areas where acceptance criteria would have been applied:

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

The document does not specify the exact sample sizes for each of the performance tests (e.g., how many needles were tested for piercing or ultrasound visibility). It only states that tests were "conducted."

The provenance of the data is in-house testing conducted by Olympus Medical Systems Corp. or its contractors. The studies appear to be bench tests and lab-based assessments (e.g., sterilization, biocompatibility, mechanical performance). There is no mention of human clinical data or patient data, so the concepts of "country of origin of the data," "retrospective or prospective," and "test set" in the context of clinical data do not apply here.

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

Given that the performance data is entirely based on bench testing (mechanical, biocompatibility, sterilization), the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense (e.g., for image interpretation) is not applicable. The "ground truth" for these engineering tests would be established by validated test methods, reference standards, and established physical/chemical properties, rather than expert human interpretation.

4. Adjudication Method for the Test Set

As the performance data is derived from bench testing, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations of clinical data) is not relevant. The results of bench tests would be determined by objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a physical medical instrument (an aspiration needle) and does not involve AI or human interpretation in a diagnostic workflow where such a study would be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an algorithm or AI-based system, so a standalone performance study in that context is not applicable.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Design Specifications: The device was tested to perform "as intended and meet design specifications."
• International Standards: Compliance with standards like ISO 10993-1, ISO 14971, ASTM F1980-16, and various ISO standards for sterilization and packaging.
• Validated Test Methods: The bench tests themselves would have employed validated methods to objectively measure parameters like flexibility, piercing force, aspiration volume, etc.

8. The Sample Size for the Training Set

This device does not utilize a "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering development and quality control, not through iterative training on a dataset.

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

Since there is no training set in the AI sense, this question is not applicable.

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These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The Single Use Aspiration Needle NA U201H are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The Single Use Aspiration Needle NA U201H consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G will be available. The Single Use Aspiration Needle NA U201H are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The Single Use Aspiration Needle NA U201H and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.

The provided document is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-U201H. The key takeaway from this document is that no clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies were conducted involving human readers or AI. The submission relies on performance data from bench and animal testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

The document mentions that "Risk analysis for the Single Use Aspiration Needle NA-U201H was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific quantitative acceptance criteria and detailed performance results for each test (e.g., insertion force, aspiration volume, etc.) are not explicitly provided in the summary. It only lists the categories of tests performed.

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

The document does not provide details on sample sizes for the bench or animal testing. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective), as the tests are described as internal performance evaluations.

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

This information is not applicable as there were no clinical studies, and therefore no a ground truth established by medical experts for a test set. The performance evaluation was based on bench and animal testing, which would involve technical personnel.

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

This information is not applicable as there were no clinical studies involving human interpretation or 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on clinical study data to demonstrate substantial equivalence." Furthermore, this device is an aspiration needle and does not involve AI.

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

No, a standalone performance study was not done, as this device is a physical medical instrument and does not involve an algorithm or AI.

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

For the bench and animal testing, the "ground truth" would be defined by the measurement standards and specifications for each test (e.g., a specific force for insertion, a certain volume for aspiration, image quality metrics for visibility, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as there were no clinical studies.

8. The sample size for the training set

This information is not applicable as there were no machine learning algorithms or AI components involved in this device, and thus no training set.

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

This information is not applicable as there was no training set.

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This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration(FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject devices are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject devices consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G are available. The subject devices are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The subject devices and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.

This document describes the premarket notification (510(k)) for the Olympus Single Use Aspiration Needle NA-U200H. It does not contain information about an AI/ML device or its performance criteria. The performance data provided are for a medical device (a biopsy needle) based on sterility, biocompatibility, and bench/animal/clinical performance evaluations, not AI/ML model metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as the provided text pertains to a traditional medical device premarket notification.

If you have a document describing an AI/ML device, please provide it, and I will do my best to extract the relevant information.

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This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

The single use aspiration needle NA-U401SX (aka ViziShot 2) is intended to be used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle, and stylet. The needle is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen that was punctured with the needle. The needle is dimpled for echo enhancement and also consists of an oval portion for better angulation.

The subject device will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.

The provided text describes a 510(k) premarket notification for the "Single Use Aspiration Needle NA-U401SX" (aka ViziShot 2). This notification primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as one might find for more complex software or diagnostic devices.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test sets, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not present in this document. This document details a medical device (a needle), and the "performance" here relates to its physical and functional attributes, not an algorithm's diagnostic capabilities.

However, I can extract the information that is available regarding the "acceptance criteria" and the "study" that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Inserting into endoscope
• Flexibility of the insertion portion
• Piercing
• Ultrasound visibility
• Needle extraction and retraction
• Aspiration
• Withdrawal from endoscope
• Locking force of handle portion
• Limitation of needle depth |
  | Biocompatibility Testing | Compliance with FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1" and relevant ISO standards (ISO 10993-1, -5, -10, -11). | Performed in accordance with the specified FDA Guidance and ISO standards. |
  | Sterilization | Compliance with ISO 11135 (Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices). | Applied ISO 11135. |
  | Packaging/Shelf Life | Compliance with ASTM F-1980-07 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages). | Applied ASTM F-1980-07. |
  | Technological Characteristics (vs. predicate) | Validation testing demonstrated that differences in needle tube shape on proximal side, sheath composition, and materials do not affect the safety or effectiveness of the subject devices. (Specifically, the oval portion of the needle tube and new patient contact materials, with sheath design similar to K904667). | Validation testing demonstrated that these technological features do not affect the safety or effectiveness of the subject devices. |

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of needles tested, number of in-vitro experiments). It refers to "testing" and "analysis" rather than specific numerical units of a test set. This is typical for a 510(k) for a physical device where tests are often on prototypes or manufacturing samples.
• Data Provenance: The studies are non-clinical ("Summary of non-clinical testing") and were conducted in-house by the manufacturer (Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. in Japan). The specific country of origin for the data generation would therefore be Japan. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission for the new device.

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

This section is not applicable as the device is a physical medical instrument (an aspiration needle) and not an AI or diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy. The "ground truth" here is the physical and functional integrity and performance of the device against engineering and safety standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions, typically in diagnostic studies or when establishing ground truth for AI model training/testing. This document describes non-clinical engineering and biocompatibility tests for a physical device.

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

This is not applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic systems or AI tools with human readers. This submission is for a physical medical device (an aspiration needle), not an AI system.

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

This is not applicable. This device is a physical medical instrument and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established by:

• Engineering specifications and design requirements: For items like flexibility, piercing ability, aspiration, locking force, and needle depth limitation.
• Regulatory standards: Specifically, ISO 14971 (Risk Management), ISO 10993 series (Biocompatibility), ISO 11135 (Sterilization), and ASTM F-1980-07 (Packaging/Shelf Life Accelerated Aging).
• Functional tests: Verification that the device performs its intended functions (e.g., "inserting into endoscope," "ultrasound visibility").

8. The sample size for the training set

This is not applicable. The device is a physical instrument, not an AI model that requires a training set.

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

This is not applicable for the same reason as above; there is no training set for a physical device. Ground truth for the design and testing of the device is established by the engineering and regulatory standards listed in point 7.

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This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject device is a Single Use Aspiration Needle NA-U200H to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "Single Use Aspiration Needle NA-U200H".

While it states that "Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended," and that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," it does not provide specific details on:

• A table of acceptance criteria and reported device performance (with specific metrics and values).
• Sample sizes used for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
• Type of ground truth used.
• Sample size for the training set (again, not applicable to a physical device in the context of AI).
• How ground truth for the training set was established.

This document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/software device.

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This instrument has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

The NA-201SX-4022 Single Use Aspiration Needle consists of a handle section, needle section, rne NN20 North section. The handle section is connected to the endoscopes instrument channel port via the single use adapter biopsy valve (MAJ-1414). The handle section facilitates the advancement of the needle section during puncture of the targeted site. The syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-201SX-4022. The syringe is used to aspirate the specimen that was punctured with the needle. The syringe has a lock function which can lock the piston (plunger) is pulled. When the stopcock is closed and the piston (plunger) keeps it evacuated. For aspiration, the syringe should be connected with the needle and the stopcock should be opened just before aspiration. The lock Connected with the need for the operator to keep pulling the piston during the procedure thus improving usability. The position to lock the piston (plunger) is selected from 4 levels. Accordingly, the operator can select the specimen size required.

The provided text is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-201SX-4022. It explicitly states in section F that no clinical data was required to establish substantial equivalence for this device. Therefore, a study proving device acceptance criteria was not performed or reported in this document. The decision was based on the device not incorporating any significant change that impacts safety and effectiveness compared to predicate devices, thus obviating the need for clinical data.

Reason for Not Requiring Clinical Data (as stated in the document):

"When compared to the predicate device, the Single Use Aspiration Needle NA-201SX-4022, WAJ-1414 and Syringe does not incorporate any significant change that impacts safety and Mro-1414 and Dynings acos not history drive. Therefore, clinical data is not necessary to establish the subject device."

Given this, the following sections cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance: This would be generated from a clinical study, which was not performed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a clinical study was used.
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): No ground truth for a clinical study was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set required 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, as this is a medical device, not an AI-assisted diagnostic tool, and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth established for a clinical study.
8. The sample size for the training set: No training set for a clinical study was used.
9. How the ground truth for the training set was established: No ground truth for a training set was established.

The document focuses on the substantial equivalence of the new device to existing predicate devices based on design and intended use, rather than presenting clinical performance data from a specific study.

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