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The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks.

The device is introduced through the instrument channel of the bronchoscope. The device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap and stopcock. The B7-2C device is 1050 mm in working length, with a pre-inflation diameter of 2.55 mm and a post-inflation diameter of 13 mm, with a max volume of 1.7 cc.

The B7-2C Occlusion Balloon is intended for use in selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis, and airway occlusion to localize air leaks.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Airway Occlusion Test: N=30 tests.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies bench testing ("Performance testing has been completed on both the predicate device as well as the subject device...").

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

• This information is not provided in the document. The tests described are bench tests, not clinical studies involving human assessments.

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

• Not applicable as the performance tests described are objective bench tests, not human assessments requiring adjudication.

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

• Not applicable. This device is a medical instrument (an occlusion balloon) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is not relevant.

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

• Not applicable as this is a medical device and not an algorithm.

7. The type of ground truth used:

• The ground truth for the performance tests (e.g., airway occlusion, burst testing) was based on objective, quantifiable measurements from bench tests. For biocompatibility and sterilization, the ground truth was regulatory standards and established testing protocols.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML model, so there is no concept of a "training set."

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

• Not applicable.

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The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.

The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.

The provided text describes the ANET Electrosurgical Applicator and its substantial equivalence determination to a predicate device (Habib EUS RFA 6700). However, it does not include specific quantitative acceptance criteria or detailed study results (like statistical performance measures, sample sizes, expert qualifications, or ground truth establishment) typically associated with the type of request. The information provided is more general, focusing on the types of tests performed to demonstrate safety and performance.

Therefore, I cannot populate all sections of your requested table and information. I will extract what is available and note what is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of specific metrics and target values (e.g., "sensitivity > 90%"). Instead, it states that the device "successfully passed all performance testing" and that its "lesion dimensions...are equivalent to those obtained with the predicate device under the same test conditions and specified power levels."

Detailed Study Information (Based on available text)

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

   • Sample Size: Not explicitly stated for any of the performance tests (biocompatibility, sterilization, electrical safety, mechanical/functional, or comparative bench-top). The text only mentions "devices tested."
   • Data Provenance: Not specified. These appear to be laboratory bench-top tests conducted by the manufacturer, not clinical studies involving human patients or specific geographic origins.

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

   • Not applicable as the reported studies are primarily bench-top validation tests comparing the physical and functional characteristics of the device/ablation lesions, not diagnostic performance studies requiring expert interpretation of medical images or pathologies.

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

   • Not applicable for the types of engineering and bench-top performance tests described.

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

   • No MRMC study was mentioned. This device is an electrosurgical applicator used for coagulation/ablation, not an AI-powered diagnostic tool.

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

   • This is not an AI algorithm; therefore, this question is not applicable. The performance tests described (e.g., lesion dimensions, mechanical function) are for the physical device itself.

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

   • For the comparative bench-top validation testing, the "ground truth" for comparison was the performance of the predicate device (Habib EUS RFA 6700) under the same test conditions and specified power levels. The measurement of "lesion dimensions" would be considered the objective outcome being compared, likely measured directly from the tissue (e.g., using calipers or imaging).
   • For other tests (biocompatibility, electrical safety, mechanical/functional), the "ground truth" or reference was adherence to established international standards (e.g., ISO, IEC) and the manufacturer's own pre-determined specifications.

7. The sample size for the training set:

   • Not applicable. This device is a medical instrument, not a machine learning model that undergoes "training."

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

   • Not applicable, as there is no training set for this device.

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This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

The PeriFLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and intended for single patient use.

The main components of the device are a handle, a sheath, a needle, and a stylet. The sheath and needle (together termed the insertion portion) are attached to the handle. The removable stylet runs the full length of the device and fits inside the lumen of the handle and the needle.

The needle is housed within the sheath. These components, i.e., the insertion portion, are inserted into the working channel of the endoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, the stylet may be used to assist with removing the sample from the needle.

The PeriFLEX Needle is available in one model only (PERIFLEX-21G), with a needle size of 21 gauge (21G). The PeriFLEX Needle can be used with the following accessories: vacuum syringe (to assist with sample collection), biopsy valve (to assist with creating a vacuum), and guide sheath (to extend the working length). However, these accessories are not included with the PeriFLEX Needle's packaging and must be obtained separately by the user.

The provided text describes the PeriFLEX Needle, an aspiration needle for collecting tissue from intrapulmonary regions through a bronchoscope. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. While specific quantitative acceptance criteria are not explicitly stated for each test in a table format, the narrative indicates that the device "met the pre-determined acceptance criteria as outlined in the test protocols."

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

• Sample Size (Test Set): Not explicitly stated with a specific number for each test. The document refers to "in vitro (bench) and ex vivo testing" and "simulated use - ex vivo (bovine lung) bench testing" for biopsy sample size.
• Data Provenance: The testing was conducted as "in vitro (bench)" and "ex vivo (bovine lung) bench testing." This suggests laboratory-based testing rather than human subject data. The country of origin is not specified but is presumably where Spiration, Inc. conducts its R&D, likely the USA given the Redmond, Washington address. The testing is considered prospective as it was performed specifically to support this 510(k) submission.

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

• The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering and material performance assessments (e.g., force, strength, leak tests, biocompatibility) rather than diagnostic accuracy assessments requiring expert interpretation of results.
• For the "Biopsy Sample Size" test, it involved ex vivo bovine lung, which implies objective measurement of tissue obtained rather than expert consensus on its characteristics.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned or relevant as the testing described is not clinical or diagnostic in nature requiring expert review or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done or reported. The device is an aspiration needle, not an imaging or diagnostic AI device that would typically undergo such a study. The focus is on the physical and mechanical performance of the tool itself.

6. Standalone (Algorithm Only) Performance

• This is not applicable as the PeriFLEX Needle is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

• The "ground truth" for the performance tests was based on engineering specifications, material science standards, and objective measurements derived from the in vitro and ex vivo tests. For example, force measurements, leak detection, and observed physical integrity against pre-determined thresholds. For biopsy sample size, it would be the objective measurement of the collected tissue from the ex vivo bovine lung.

8. Sample Size for the Training Set

• Not applicable. There is no algorithm or AI model being developed or trained for this device.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set mentioned or implied.

In summary, the information provided focuses on the physical, mechanical, and biological performance of the PeriFLEX Needle against engineering and safety specifications, rather than clinical efficacy or diagnostic accuracy that would typically involve a "test set" and "ground truth" derived from human clinical data or expert consensus. The study described is a series of pre-clinical bench and ex vivo tests demonstrating the device's conformance to its design requirements and equivalence to predicate devices.

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The ViziShot FLEX has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose of the than its intended use.

The ViziShot FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although the device has a component called a needle, the device is often referred to as a needle as well.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve. The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot FLEX is available in one model only (NA-U402SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Olympus Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot FLEX.

This document is a 510(k) premarket notification for the ViziShot FLEX, a device designed for ultrasound-guided fine needle aspiration (FNA) of tracheobronchial lesions. This submission focuses on demonstrating substantial equivalence to a predicate device, the Flexible 19G EBUS Needle (K142909), primarily through bench testing to confirm its performance and technological characteristics.

Here's an analysis of 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

The submission does not present a formal table of "acceptance criteria" with quantitative performance metrics for device performance in a diagnostic sense (e.g., sensitivity, specificity for disease detection). Instead, the acceptance criteria are generally qualitative and relate to the device's functional integrity, safety, and operational capabilities in a simulated clinical setting. The "reported device performance" refers to the successful completion of these tests.

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

The document does not explicitly state the specific sample sizes (e.g., number of devices, number of trials) for each individual bench test. It broadly states: "Device performance of the ViziShot FLEX was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting. All testing met the pre-determined acceptance criteria as outlined in the test protocols." The provenance of the data is from in vitro (bench) and ex vivo (bovine lung) testing, implying controlled laboratory conditions rather than human clinical data. The country of origin for the data is not specified but is implicitly associated with the manufacturer, Spiration, Inc., based in Redmond, Washington, USA. The data is thus prospective, as it was generated specifically for this 510(k) submission.

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

This type of information is generally not applicable to bench and ex vivo testing studies focused on device functionality and safety. Ground truth in this context would be defined by engineering specifications and objective measurements (e.g., force transducers, calibrated measurement tools, visual inspection against design specifications). There were no human experts establishing a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves objective bench and ex vivo measurements against engineering specifications, not expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics of the device itself, not on the effectiveness of human readers using the device for diagnostic purposes. Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI is not part of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The ViziShot FLEX is a mechanical medical device (an aspiration needle), not an AI algorithm. Its performance is intrinsically linked to human operation by a clinician.

7. Type of Ground Truth Used

For the bench and ex vivo testing, the "ground truth" was established by pre-defined engineering specifications, material properties, and functional requirements (e.g., specific force thresholds, dimensional tolerances, successful aspiration of tissue, maintenance of sterility). For biocompatibility, the ground truth was adherence to established ISO standards (ISO 10993-1, ISO 10993-7).

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the machine learning sense. The "training" for the device's design implicitly comes from prior engineering knowledge and the design of the predicate device.

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

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the design and development of the device (if one were to stretch the analogy) would be established through established biomedical engineering principles, clinical needs, safety standards, and lessons learned from the predicate device.

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The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The Flexible 19G EBUS Needle is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle.

To perform biopsies, the flexible catheter portion is first inserted into a bronchoscope's working channel (2.2mm) then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope using an adapter biopsy valve. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal of the handle. The device is available with a needle size of 19 qauqe (19G).

Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) document for the Flexible 19G EBUS Needle:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria with specific numerical thresholds for each test. Instead, it indicates that "All testing met the predetermined acceptance criteria as outlined in the test protocols." and reports "Pass" for each test. The acceptance criteria were either identical to the predicate or established to verify design differences.

¹ For direct comparison to a commercially available device of the same size, testing was also conducted on the Boston Scientific 19G Scientific eXcelon Transbronchial Aspiration Needle.
² Testing also conducted on the predicate 21G Olympus Aspiration Needle.

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

The document does not specify the exact sample sizes (number of devices tested) for each individual test conducted. It generally refers to "bench testing" and "ex vivo testing."

Regarding data provenance:

• Country of Origin: Not specified. It's likely the testing was conducted by the manufacturer, Spiration, Inc., based in Redmond, WA, USA, or a contract lab.
• Retrospective or Prospective: The testing described is prospective as it involves the evaluation of the new device's performance against predefined criteria.

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

This type of information is not applicable to this specific submission. The device is a medical instrument (FNA needle), not a diagnostic algorithm that requires expert-established ground truth from a dataset. The performance evaluation focuses on physical and functional characteristics, not diagnostic accuracy based on expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. No expert adjudication method (like 2+1, 3+1) was required or described for assessing the physical and functional performance of a medical instrument.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI algorithms where human interpretation plays a role and comparison of performance with and without AI assistance is needed. This document focuses on the physical and functional performance of a medical device.

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

No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the engineering and material specifications and established performance benchmarks for aspiration needles, as well as the behavior of the predicate device and a comparable 19G device. For example:

• Physical measurements and engineering tolerances: For forces, angles, dimensions.
• Standardized test methods: For durability, vacuum integrity, and biocompatibility.
• Observed functional performance: In simulated use (ex vivo bovine lung) and comparison to the predicate and a similar 19G device for aspects like biopsy sample size.
• Biocompatibility standards: ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This device is a physical instrument and does not involve AI or machine learning models that require a training set.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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