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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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The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.

The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.

The provided document is a 510(k) summary for the Olympus Disposable Grasping Forceps FG-52D/FG-54D. It outlines the device's characteristics, indications for use, comparison to a predicate device, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves 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 with corresponding performance results in a consolidated format. Instead, it lists the types of tests conducted to demonstrate safety and effectiveness. The "acceptance criteria" are implied by the successful completion and positive results of these tests, leading to the conclusion of substantial equivalence.

Here's a re-formatted table based on the provided "Performance Data" section:

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

The document does not specify exact sample sizes for each test conducted. It generally states that "Performance Data" was provided. For the provenance, the data seems to be from non-clinical bench testing conducted by the manufacturer, Olympus Medical Systems Corp. The document does not mention the country of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing.

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 to this submission. The device is a physical medical instrument (graspers), not an AI/ML algorithm that requires expert labeling for ground truth. The "ground truth" for its performance is established through standardized engineering and biological tests, not expert consensus on data interpretation.

4. Adjudication method for the test set

This information is not applicable as the device is not an AI/ML algorithm that involves human interpretation 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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical grasping forceps.

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

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized testing methodologies as referenced in the performance data section (e.g., ISO standards for biocompatibility, sterilization, packaging, and specific mechanical tests like insertion force, grasping performance, and strength testing). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML validation for this type of medical device.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm.

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The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Intended patient population: Adults

The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.

The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.

The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.

The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.

The provided text is a 510(k) summary for a medical device (Disposable Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic product. The document describes a traditional medical device (a cytology brush), not an AI/software device.

Therefore, many of the requested categories for AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to non-clinical testing performed to demonstrate the device's performance and safety, which serves a similar purpose to meeting acceptance criteria for a physical device.

Here's the breakdown based on the provided text:

Device: Disposable Cytology Brush (AF series)

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

The document doesn't present a formal table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one would for an AI diagnostic. Instead, it lists performance tests conducted to verify the device meets design specifications and is substantially equivalent to a predicate. The "acceptance criteria" are implied to be "met all design specifications" and "demonstrated safety and essential performance" based on applicable standards. The "reported device performance" is summarized as the tests being successfully performed and demonstrating substantial equivalence.

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

• Sample Size: The document does not specify the exact number of devices/samples used for each non-clinical test (e.g., how many brushes were tested for tensile strength).
• Data Provenance: The tests are described as "Non-clinical testing for Disposable Cytology Brush." The document's origin (Alton (Shanghai) Medical Instruments Co. Ltd in China) suggests the testing likely occurred there or was managed by them. The studies are bench (laboratory) tests and do not involve patient data in the typical sense of a clinical study.

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

• Not Applicable. This is a physical medical device. Ground truth, in the AI/diagnostic sense, is not established by human experts for these mechanical/biocompatibility tests. The "ground truth" here is compliance with engineering specifications and recognized international standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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/imaging device that would involve human readers.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO 10993 standards (e.g., no cytotoxicity, no irritation).
• For sterilization: Adherence to ISO 11135 standards (e.g., Sterility Assurance Level of 10-6).
• For shelf life/sterile barrier: Adherence to ASTM and ISO 11607 standards (e.g., package integrity, product performance after aging).
• For mechanical performance: Meeting internal design specifications and demonstrating performance comparable to the predicate device through side-by-side bench testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set.

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

• Not Applicable. See point 8.

In summary, this 510(k) pertains to a traditional medical device (a cytology brush) and not an AI or software-driven diagnostic tool. Therefore, the information provided in the document focuses on demonstrating substantial equivalence through non-clinical bench testing, biocompatibility, and sterilization validation, rather than the types of studies typically conducted for AI-powered diagnostic devices.

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METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.

The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.

The document describes the acceptance criteria and performance of the METIC™ Airway Balloon Catheter, but it does not involve a study based on artificial intelligence or machine learning. Instead, it describes laboratory and bench testing for a physical medical device. Therefore, several sections of your requested output, which are relevant to AI/ML studies, cannot be extracted from this document, as they are not applicable.

Here's the information that can be extracted relevant to the physical device's performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

• Visual Inspection
• Dimensional Measurement
• Balloon Burst and Balloon Compliance
• Inflation and Deflation Time
• Catheter Bond Strength
• Flexibility and Kink
• Torquability
• Catheter Fatigue
• Balloon Hub Measurement
• Proximal Luer fitting
• Balloon Preparation, Deployment and Retraction"

The document then states in the conclusion: "The performance, biocompatibility, sterilization, packaging and shelf life study conducted on METIC™ – Airway Balloon Catheter demonstrated the device is as safe and as effective as the predicate device." Indicating these tests met the criteria. |
| Balloon Diameter @ Nominal Pressure | 5.0 X 24mm: 10 ATM
7.0 X 24mm: 10 ATM
9.0 X 24mm: 10 ATM
10.0 X 40mm: 7 ATM
12.0 X 40mm: 7 ATM
14.0 X 40mm: 7 ATM
16.0 X 40mm: 7 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Fatigue Test | Catheter shall withstand 10 cycles minimum to Rated Burst Pressure
Rated Burst Pressure:
5.0 X 24mm: 17 ATM
7.0 X 24mm: 17 ATM
9.0 X 24mm: 17 ATM
10.0 X 40mm: 10 ATM
12.0 X 40mm: 10 ATM
14.0 X 40mm: 10 ATM
16.0 X 40mm: 10 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Inflation Time | ≤ 25 seconds | (See above for general statement on performance evaluation and conclusion) |
| Balloon Deflation Time |

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The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling.

The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

The Praxis Medical EndoCore is a device used with an ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree in patients 18 years and older requiring tissue sampling. The device utilizes a battery-powered internal motor to rotate the needle, facilitating cellular material collection, and employs standard vacuum syringe techniques for biopsy.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each "test set" within the non-clinical testing. The non-clinical testing consisted of various laboratory-based tests (Biocompatibility, EMC/Electrical Safety, Bench Testing) and did not involve human patient data test sets. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these specific non-clinical tests.

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

This question is not applicable to the provided document. The non-clinical tests described are objective, laboratory-based evaluations against recognized standards (e.g., ISO, IEC). There is no mention of "experts" being used to establish a subjective "ground truth" for these performance tests, nor are there any clinical studies involving expert interpretation of device output.

4. Adjudication Method for the Test Set

This question is not applicable. The non-clinical tests are objective and do not involve adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided document. The device is a physical instrument for tissue sampling, not an AI-powered diagnostic tool.

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

This question is not applicable. The device is a physical instrument and does not involve an algorithm working in a standalone capacity.

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

The "ground truth" for the non-clinical performance tests is represented by established international and national standards (e.g., ISO 10993, IEC 60601, ISO 80369, ISO 11070) for medical device safety and performance. Device performance was evaluated against the requirements outlined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical instrument, not an AI/machine learning algorithm that requires a training set.

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

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

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The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.

The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

The provided text is a 510(k) Summary for medical device clearance, specifically concerning the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. It outlines the safety and effectiveness information for these devices and compares them to a predicate device.

However, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for details like:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established.

The provided document describes physical medical devices (valves for bronchoscopes), not an AI/algorithm. Therefore, concepts like "AI assistance," "human readers," "effect size of human readers improve with AI," "standalone algorithm performance," and "training/test sets for an algorithm" are not applicable to the information given.

The document does mention "Performance Test" in Section 9, stating:
"The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications."

While this section indicates that performance tests were done and met specifications, it does not provide the acceptance criteria or the specific performance results in a quantitative manner. It also does not involve human readers, AI, or traditional "ground truth" as it would apply to a diagnostic algorithm.

Conclusion based on the provided text:

The provided document is for physical medical devices (valves), not an AI/algorithm. Therefore, most of the requested information (related to AI performance, human reader studies, training/test sets for AI, ground truth establishment for AI) is not present and not applicable to this submission.

The document states that bench testing was performed and the devices met established specifications. However, the specific quantitative acceptance criteria and the reported performance values are not detailed in this summary.

To answer your request based only on the provided text:

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

   • Acceptance Criteria: Not explicitly detailed in quantitative terms within the summary, but implied that each test (endoscope compatibility, suction flow, vacuum leak, water leak, pressing force, fatigue, squeegee leak) had "established specifications."
   • Reported Device Performance: The document summarily states: "The performance data demonstrated that the subject devices met established specifications." No specific quantitative results are provided.

2. Sample sized used for the test set and the data provenance: Not applicable to this type of device testing as described. The testing is bench testing on physical units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for these physical devices would be their ability to perform their mechanical functions according to engineering specifications.

8. The sample size for the training set: Not applicable (not an AI/ML algorithm).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML algorithm).

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MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.

The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.

This document is a 510(k) Summary for a medical device called the "MultiStage Balloon Dilatation Catheter." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel AI/software device.

Instead, the document focuses on demonstrating that the proposed device is "substantially equivalent" to a predicate device. This is achieved by showing similar intended use, technological characteristics, and principles of operation, and by performing non-clinical tests to ensure safety and effectiveness.

Here's an attempt to extract the requested information, understanding that it will be framed within the context of substantial equivalence rather than a direct performance study against defined acceptance criteria for, for example, a diagnostic accuracy claim:

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

The document doesn't explicitly state "acceptance criteria" in terms of specific quantitative thresholds to be met for diagnostic performance (as would be typical for an AI/software device making a diagnostic claim). Instead, the "acceptance criteria" are implied by the standards and performance characteristics tested for a physical medical device, and the "reported device performance" is that the device passed these tests and is considered "safe and effective."

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

The document lists "non-clinical tests" which include physical, chemical, and biological performance testing of the device and its components. The sample sizes for these specific engineering and biocompatibility tests are not disclosed in this summary. The data provenance is primarily from laboratory testing of the manufactured device. There is no mention of patient data or its origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of submission. The device is a physical medical instrument, not a diagnostic AI/software that requires expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to establish a consensus ground truth for diagnostic decisions. This submission focuses on non-clinical performance and substantial equivalence to a predicate 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not for a physical balloon dilatation catheter.

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

This refers to AI/software performance. The device is a physical catheter, so a "standalone" algorithm performance study is not applicable.

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

For the non-clinical tests, the "ground truth" is defined by the specifications, requirements, and methods outlined in the referenced international standards (e.g., ISO 10993-1 for biocompatibility, ASTM F1980 for shelf life, ISO 11135 and ISO 11607-1 for sterilization). There is no clinical ground truth involving patient outcomes or expert consensus for this type of submission.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set for model development.

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

This is not applicable as there is no training set for a physical medical device.

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The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.

The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle. Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters. Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet. The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.

The provided text is a 510(k) summary for the Serpex Medical, Inc. Compass Steerable Needle. It outlines the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, it does not describe a study that proves the device meets specific acceptance criteria in terms of AI model performance, diagnostic accuracy, or clinical effectiveness as typically seen for AI/ML-enabled devices.

Instead, the "acceptance criteria" and "study" described in the document refer to standard medical device verification and validation activities for a new physical medical device (a steerable biopsy needle), focusing on its engineering performance, safety, and functionality. This includes:

• Bench Testing: Mechanical and functional performance of the device.
• Validation Testing: Simulated use conditions, including human cadaver testing for clinical performance.
• Human Factors Usability: Assessment of user interface and potential use errors.
• Biocompatibility: Evaluation of material safety in contact with human tissue.
• Sterilization: Validation of the sterilization process.

Therefore, I cannot extract the information required for an AI/ML-driven device's acceptance criteria and study proving it meets them. The prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to the content of this 510(k) summary.

In summary, the provided document details the regulatory clearance process for a physical medical device (a steerable biopsy needle), not an AI/ML diagnostic or assistive device. Consequently, it does not contain the information requested regarding AI model performance, expert adjudication, or MRMC studies.

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The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue.

The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound.

The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Endobronchial Ultrasound Aspiration Needle (AreusTM and TridentTM) and its equivalence to a predicate device. However, the document does not contain specific acceptance criteria nor detailed study results with performance metrics that would allow for the construction of a table comparing acceptance criteria to reported device performance.

Instead, the document broadly states that the device "met the predetermined acceptance criteria" without listing those criteria or the precise performance values attained for each. It focuses on demonstrating substantial equivalence through various non-clinical tests.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract the information that is present in the document.

Missing Information:

• Specific acceptance criteria values: The document states that criteria were met but doesn't define them.
• Reported device performance values: Similarly, specific performance numbers are not provided, only a general statement that they "met" the criteria.
• Details on the "study" itself: No specific study names or designs are outlined, beyond mentioning various bench tests and validation activities.
• Sample size used for the test set: Not specified.
• Data provenance for the test set: Not specified (e.g., country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth: Not applicable, as the tests were non-clinical/bench tests, not involving human interpretation of medical images or data.
• Adjudication method for the test set: Not applicable for non-clinical tests.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not done/not applicable, as it's a device, not an AI diagnostic tool.
• Standalone (algorithm only) performance: Not applicable, as it's a physical medical device.
• Type of ground truth used (for test set, if applicable): Not applicable for non-clinical/bench tests.
• Sample size for the training set: Not applicable, as it's a physical medical device, not an AI algorithm requiring a training set.
• How ground truth for the training set was established: Not applicable.

Here's a summary of the information that is available in the document regarding the device's testing and compliance:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific numerical acceptance criteria and reported device performance values are not provided in this document. The document states:

"The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex."

The following types of tests were performed:

• Dimension
• Sheath and Needle Insertion and Withdrawal force
• Stylet Insertion and Withdrawal Force
• Puncture Force
• Ultrasound Visibility
• Locking Force of Handle Portion
• Adjustment Length
• Attach and Detach Adaptor to Scope
• Tensile Strength
• Durability
• Aspiration Capability
• Transmission Force
• Needle Deformation Angle

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

• Sample size for the test set: Not specified in the document.
• Data provenance: Not applicable. These were non-clinical bench tests performed on the device itself.

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

• Not applicable. The ground truth for these non-clinical, physical performance tests would be based on engineering specifications and measurement standards, not medical expert consensus.

4. Adjudication method for the test set

• Not applicable. This is for non-clinical, physical performance tests.

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

• No. This is a physical medical device (Endobronchial Ultrasound Aspiration Needle), not an AI-powered diagnostic tool, so an MRMC study is not applicable.

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

• For the non-clinical bench tests, the "ground truth" would be the engineering specifications and established test methods/standards (e.g., measurements against dimensional tolerances, force thresholds, durability cycles). For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's compliance with ISO 11135. For shelf-life/packaging, it's compliance with ASTM F1980-16, ISO 11607-1, and ISO 11607-2.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

Ask a specific question about this device

The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.

The Pulmonary Balloon Catheters are multi-lumen catheters with a dilation balloon on the distal tip. The catheters have two extension legs with luer connectors on the proximal end. The catheter is designed to pass through the working channel of a bronchoscope and accept a 0.035 in (0.89 mm) X 260 cm guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon.

The dilation balloon will be available in a 7.5F catheter with a length of 1.5 cm and in one additional balloon diameter of 4mm range that will be added to the current range from to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopague marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.

The provided text is a 510(k) summary for the Elation™ Pulmonary Balloon Dilation Catheter. It outlines the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that explicitly establishes acceptance criteria and then proves the device meets those criteria through a detailed performance study as would be seen in a clinical trial.

Instead, the document details a series of non-clinical, bench-top tests designed to show that the modified device (with a smaller balloon diameter and shorter length) performs equivalently to its predicate. The text states "All tests passed the predetermined acceptance criteria," but it does not list these specific criteria or provide detailed results from a study proving this. It also mentions a "design validation study... with porcine lungs to demonstrate the safety of dilation of smaller (6mm diameter or below) bronchi," but no specific data or acceptance criteria for this study are provided.

Therefore, many of the requested items cannot be fully answered from the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device