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The device is used for drawing osteomedullary substance and/or for bone marrow explantation.

Trap Easy is a bone marrow biopsy needle, consisting of a cannula with cylindrical tip and ergonomic handle, a removable pyramidal stylet, a sample trapping device integrated into the cannula and an extraction wire.
The device is used for drawing osteomedullary substance and/or for bone marrow explantation. This device is intended to be used only by experienced and properly trained physicians and is intended to be used exclusively for bone marrow tissue biopsies.
The device is available in different models:

• 8G x 100 mm
• 8G x 150 mm
• 11G x 100 mm
• 11G x 150 mm
  Trap Easy is supplied in sterile packaging and is designed for single use, non-reusable. At the end of its use, the device should be disposed of as infectious hospital waste.

This looks like a 510(k) summary, which typically does not include raw data or detailed study protocols for performance testing, but rather summarizes the results and demonstrates substantial equivalence to a predicate device. The information provided is sparse regarding the detailed breakdown of the acceptance criteria and study particulars for Trap Easy.

However, based on the provided text, here’s an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions acceptance criteria but does not explicitly list them with thresholds. It states that "The average lengths and diameters were compliant with acceptance criteria." and "Performed tests show that all the 50 samples have a good integrity and there were no samples ruined or divided in small parts."

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

• Sample Size for Test Set: 50 samples were tested for integrity, length, and diameter.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies appear to be non-clinical performance tests conducted by the manufacturer, HS Hospital Service SPA (located in Italy).

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

This appears to be a study of the physical characteristics and performance of a device, not an interpretative AI algorithm. Therefore, the concept of "experts to establish ground truth" as it pertains to clinical interpretation is not applicable here. The "ground truth" for the physical performance metrics (integrity, length, diameter, removal ease, mechanical function) would be established by direct measurement and observation during the testing process. The document does not specify the number or qualifications of personnel who performed these tests or evaluated the results.

4. Adjudication Method for the Test Set

Not applicable as this is a device performance test, not a clinical interpretation task requiring adjudication.

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

No. This document describes the performance testing of a physical biopsy device, not a software or AI algorithm requiring an MRMC study.

6. If a Standalone Study (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 Sample Integrity, Length, Diameter, and Removal: The ground truth was established through direct observation and quantitative measurements during the performance tests.
• For Mechanical Functioning: The ground truth was established by direct observation and inspection for damages after the biopsies.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided text summarizes performance tests conducted on the "Trap Easy" device to demonstrate its performance characteristics. The tests evaluated:

• Sample integrity after biopsy: All 50 tested samples reportedly had "good integrity" with no samples being "ruined or divided in small parts."
• Sample length of single biopsy: The average lengths were reported as "compliant with acceptance criteria," although the specific criteria or measured values are not detailed.
• Sample diameter: The average diameters were also reported as "compliant with acceptance criteria," without specific values provided.
• Sample removal: It was noted that "sample removal was easy for all samples."
• Mechanical functioning of the needle: The tests concluded that "the needles didn't show any damages to the internal mechanism after all biopsies."

The studies were conducted in a manner "as similar as possible to how the biopsy device is used in a medical procedure." The overall conclusion from these tests is that "Obtained results demonstrated that the device's performances are maintained for the intended use of the device."

It appears these were non-clinical, bench-top performance tests, rather than clinical trials with human subjects. The details regarding the exact methodology, measurement tools, and statistical analysis are not available in this summary document.

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Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

The devices subject of this submission, generator AGN-H-1.3, generator AGN-3.3 and AMICA-PROBE 17G & 18G applicators, belong to the HS AMICA devices family and they represent an evolution and implementation of previous models, already authorized by FDA under K182605. The working configuration of the HS AMICA commercial system consists of:

• . A programmable generator for the generation and control of the energy required for the thermoablative treatment;
• . Disposable applied parts (or applicators) for the direct release of energy into the patients or for temperature measurements inside the patient's body.
  The result is an integrated system for thermoablation of tissues through controlled emission of nonionizing electromagnetic radiations in the microwave and radiofrequency ranges. The generators and its accessories are able to emit only microwaves (MW, 2450 MHz), or only radiofrequency waves (RF, 450 kHz) or either microwaves or radiofrequency waves (not simultaneously). The new electrosurgical devices introduced by H.S. Hospital Service S.p.A. are the AMICA-GEN models named AGN-H-1.3 and AGN-3.3, along with 17G and 18G AMICA-PROBE disposable applicators.

This document describes the premarket notification (510(k)) for the HS AMICA devices family, specifically the AMICA-GEN AGN-H-1.3 and AGN-3.3 generators, and AMICA-PROBE 17G & 18G applicators. The submission aims to establish substantial equivalence to a previously cleared device (K182605).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate devices through adherence to safety and performance standards for electrosurgical cutting and coagulation devices. The reported device performance primarily focuses on the device's functionality, adherence to electrical safety and EMC standards, and a single ex-vivo bench test for the new applicators.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

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

• The document mentions "ex-vivo test" for the 18G-gauge AMICA-PROBE.
• Sample Size: Not specified for the ex-vivo test.
• Data Provenance: The ex-vivo test was conducted by HS Hospital Service Spa. The country of origin for the test is not explicitly stated, but the company is based in Italy. The study is a bench test, and inherently retrospective in the sense that the results were analyzed after the experiments. It is not a clinical study involving human subjects or patient data.

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

• This information is not provided. The study appears to be a bench test rather than a clinical study requiring expert consensus on image interpretation or clinical outcomes. The "ground truth" for a bench test would be objective measurements of physical parameters (e.g., ablation volume, temperature distribution), which are typically established by the testing methodology itself, not by expert readers.

4. Adjudication Method for the Test Set:

• Not applicable as this is a bench test, not a study requiring reader adjudication on a test set.

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

• No, an MRMC comparative effectiveness study was not performed. This submission focuses on demonstrating substantial equivalence for an electrosurgical device family, particularly new models and smaller-gauge applicators, primarily through engineering principles, electrical safety, EMC, software validation, and bench testing. It does not involve AI software or human-in-the-loop performance evaluation.

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

• No, a standalone algorithm performance study was not performed. This device is a hardware electrosurgical system with integrated software, not a standalone diagnostic AI algorithm.

7. Type of Ground Truth Used:

• For the ex-vivo bench test, the ground truth would be objective physical measurements related to ablation performance (e.g., thermal lesion size, shape, or temperature profiles) achieved in the ex-vivo tissue model. The document states "validate the functional ablation performances," implying that quantitative or qualitative measurements of the ablation were the "ground truth" for this specific test.

8. Sample Size for the Training Set:

• Not applicable. This device is an electrosurgical system, not an AI/ML model that undergoes a "training" phase with a dataset. The software validation is based on standard software engineering principles and testing, not machine learning.

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

• Not applicable, as there is no "training set" for this type of medical device submission.

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Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.

HS AMICA devices family is a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
AMICA-GEN is available in the following different models: AMICA-GEN AGN (Microwave generator only), AMICA-GEN AGN-R (Radiofrequency generator only), and AMICA-GEN AGN-H (Hybrid Microwave and Radiofrequency generator). The MW and RF outputs can never be activated simultaneously. The actual energy source in use depends on the applied part type, RF or MW, connected to the generator.
There are several available variants of PROBE (i.e. the applied parts for direct energy delivery into the patient's body for percutaneous or intra-operative use): AMICA-PROBE (disposable device for MW energy delivery) and RF AMICA-PROBE (monopolar, straight, stainless steel electrode for RF energy delivery).
HS AMICA devices family consists of non-sterile reusable electronic parts, and sterile disposable applied parts. The sterilization method used for all the sterile components is Ethylene Oxide.
The microwave devices can be operated in continuous and PULSE mode. The PULSE mode is new operational mode with a duty cycle of 40% and a max output power of 190 Watts.

The provided text is a 510(k) Summary for a medical device (HS AMICA devices family) seeking clearance from the FDA. It primarily focuses on comparing the new device to a predicate device and demonstrating substantial equivalence through various tests and compliance with standards.

However, the document does not describe an AI/ML-based medical device. The "AI" term in the prompt implies such a device. This document describes an "Electrosurgical Cutting and Coagulation Device and Accessories," which uses microwave and radiofrequency energy for thermo-ablation of soft tissues. The software update mentioned (Rev. 1.7.1) appears to be a general software update for device control, not an AI/ML algorithm for diagnostic or prognostic purposes.

Therefore, the specific information requested about acceptance criteria and studies for an AI/ML device (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) is not present in the provided text as it pertains to an AI/ML aspect.

The document does mention "Performance Data" and "Thermal Effects performance tests" with ex-vivo bovine liver, kidney, and muscle as part of the verification and validation studies. It states that "the system passed all pre-determined acceptance criteria identified in the test plan." However, it does not explicitly list these acceptance criteria or the reported performance in a quantitative, granular way as would be expected for an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). The nearest it comes to a performance claim is that "PULSE mode ablations allowed for slightly more spherical ablations."

Based on the provided text, I cannot fulfill the request for information regarding AI/ML device acceptance criteria and study details because the device described is not an AI/ML device.

If the question were rephrased to be about the non-AI medical device described in the document, here's what could be extracted, though it would still be limited:

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

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

• The document mentions "Thermal Effects tests with ex-vivo bovine liver, kidney and muscle." No specific sample sizes (number of tissue samples or experiments) are provided.
• Data provenance: Ex-vivo bovine tissues.

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

• Not applicable/Not mentioned, as this is a performance test on tissue, not an AI ground truth establishment.

4. Adjudication method for the test set:

• Not applicable/Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done as this is not an AI/ML device for interpretation.

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

• The device itself is a standalone electrosurgical system. The performance tests were of the device's ability to ablate tissue.

7. The type of ground truth used:

• The "ground truth" for the performance tests was the observable thermal ablation effects on ex-vivo bovine tissues (e.g., size and shape of ablation zone).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

HS AMICA devices family is an integrated system for thermoablation of tissues through controlled emission of non-ionizing electromagnetic radiations in the microwave and radiofrequency ranges. Especially the HS AMICA family consists of 3 devices and relative accessories emitting: 1. Only microwaves (MW) or 2. Only radiofrequency waves (RF) or 3. Either microwaves or radiofrequency waves (not simultaneously). The three devices emit the specific wavelength through their applicators (probes) that are inserted into the human body and deliver electromagnetic energy through their emitting tip, causing the thermoablation. Briefly, the HS AMICA devices family consists of two main components: 1) the generator; 2} the applicator (probe). The generator of the electromagnetic energy is available in the following variants, depending on the specific electromagnetic emission: 1. AMICA GEN AGN-H. This variant is characterized by both the MW and RF modules that must be selected by the physician. When the MW function is selected, the RF emission is disabled and viceversa and thus the modules operate in mutually exclusive fashion 2. AMICA GEN AGN. This variant has only the MW module. 3. AMICA GEN AGN-R This variant has only the RF module. In all cases, the AMICA GEN is provided with an electronic control unit (EC), for data exchange with the patient applied parts, the interpretation of user's commands through front panel controls or external peripherals (such as the footswitch for remote energy start/stop), the continuous update of the machine indicators, and the control of the energy generation modules MW and/or RF. The applicator (probe) is disposable and consists of the following variants, to be used for the MW or RF thermoablation: 1. AMICA PROBE. This variant is a microwave coaxial antenna of asymmetric dipole type allowing the emission of the MW energy 2. RF AMICA-PROBE. This variant is used for radiofrequency energy delivery through monopolar interstitial electrode.

The provided text is a 510(k) Summary for the HS AMICA devices family, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices (K083157 and K053290) through a comparison of technological characteristics and performance data.

However, the document does not contain the level of detail typically required to fully answer a request for acceptance criteria and a study proving a software/AI-based device meets those criteria, especially regarding clinical study design elements like sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies for AI performance.

The "Performance Data" section discusses:

• Electrical safety
• Electromagnetic compatibility
• Software verification and validation (developed and validated according to FDA guidance and IEC 62304:2006, but no specific performance criteria or results are given beyond "compliance")
• Biocompatibility
• Performance test-bench: This is the closest to device performance, focusing on physical ablation size on ex-vivo tissues for both microwave and radiofrequency components, compared to predicate devices.

Therefore, many parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as the document describes a traditional electrosurgical device, not an AI/software-driven diagnostic or assistive system with the types of performance metrics you've outlined.

However, I can extract the information that is present and indicate where information is missing based on the context of the document.

Acceptance Criteria and Device Performance (Based on available information for a physical device, not AI)

Detailed Study Information (Based on a typical AI/Software Device Request vs. Provided Document)

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

   • Provided: For the "Performance test-bench" (ablation size), the data provenance is "ex-vivo tissues (muscle, liver, lung and kidney)". No specific number or type of "samples" (e.g., number of tissue blocks, number of ablation procedures) is given, nor is the origin country. This is not a clinical test set in the context of AI.
   • Missing for AI: No information on test set size (e.g., number of images, cases) or data provenance (e.g., retrospective/prospective, number of sites/patients, country of origin) for AI performance evaluation.

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

   • Provided: Not applicable. The "ground truth" for the performance test was the physical measurement of ablation size on ex-vivo tissues. This was a physical measurement, not an expert-derived truth.
   • Missing for AI: No information on expert involvement or their qualifications.

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

   • Provided: Not applicable. Ground truth was direct measurement for the physical performance test.
   • Missing for AI: No information.

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:

   • Provided: No. This study was not an MRMC comparative effectiveness study involving human readers. It was a comparative performance test of a physical device against its predicates on ex-vivo tissue concerning ablation size and general safety/EMC standards.
   • Missing for AI: No information.

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

   • Provided: Not applicable. This device is an electrosurgical unit, not an algorithm performing a standalone diagnostic or assistive function on its own data inputs (like images). The "software verification and validation" mentioned refers to the embedded software that controls the hardware, not an AI algorithm for autonomous decision-making or analysis.
   • Missing for AI: No information.

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

   • Provided: For the "Performance test-bench," the ground truth was the physical measurement of the size (depth, width, length) of the ablation zone created on ex-vivo tissues.
   • Missing for AI: Not applicable in the context of this device.

7. The sample size for the training set:

   • Provided: Not applicable. This device is not an AI model that undergoes a "training set" in the machine learning sense. The "training" relates to the design and testing process of the engineering.
   • Missing for AI: No information.

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

   • Provided: Not applicable. See point 7.
   • Missing for AI: No information.

In summary, the provided document from the FDA is a 510(k) summary for a traditional electrosurgical device, not an AI-powered diagnostic or assistive medical device. As such, it details engineering and safety performance (electrical safety, EMC, biocompatibility, and physical ablation size) relative to predicate devices, rather than the complex clinical validation and ground truth establishment methods typical for AI/ML-based software products.

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