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It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.

The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.

The provided text is a 510(k) summary for an "Introducer Needle" device. It outlines the device's comparison to a predicate device and the performance data submitted to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

The performance data section (9. Performance Data) details physical and chemical performance testing, biocompatibility testing, and packaging/shelf-life testing, which are standard for medical devices like introducer needles. These tests are to demonstrate the device meets design requirements and performs as intended, but they do not involve acceptance criteria related to algorithmic performance, expert image interpretation, or human reader improvement with AI assistance.

Therefore, I cannot provide the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device, as this document pertains to a physical medical device.

Here's what I can extract from the provided text regarding the physical device's "acceptance criteria" and "performance data" if interpreted broadly:

Acceptance Criteria and Reported Device Performance (Physical Device)

The document doesn't explicitly list "acceptance criteria" in a table format with specific quantitative thresholds that need to be met for each test for the "Introducer Needle." Instead, it states that "Performance testing was performed in accordance with applicable clauses in ISO 9626-2016 and ISO 7864-2016" and that the testing was "to demonstrate that the Introducer Needle met applicable design requirements." The conclusion then states, "The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended."

However, based on the performance tests listed, we can infer the "acceptance criteria" are implied by meeting the standards of ISO 9626-2016 (presumably for stainless steel needle tubing for the manufacture of medical devices) and ISO 7864-2016 (likely for sterile hypodermic needles for single use).

Here's a representation of the implied acceptance criteria based on the testing performed, and the "reported performance" is that the device met these criteria.

Other Requested Information (Not Applicable to this Document as it's not an AI/ML Device)

The following points are not applicable to the provided document, as it describes a physical medical device (introducer needle) and not an AI/Machine Learning device. Therefore, information regarding AI/ML-specific testing is absent.

• Sample sizes used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. The "test set" here refers to physical units subjected to tests.
• 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 refers to engineering specifications and performance standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For this physical device, the ground truth is established by the specified engineering standards (ISO 9626-2016, ISO 7864-2016) and biocompatibility standards (ISO 10993 series).
• The sample size for the training set: Not applicable (no ML training).
• How the ground truth for the training set was established: Not applicable (no ML training).

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The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.

This device is intended for adult and pediatric patients.

The BD™ Spinal Introducer Needle is intended for placement or introduction of spinal needles.

This device is intended for adult and pediatric patients.

The BD Quincke Spinal Needle, BD Whitacre Spinal Needle are available in various gauges and needle lengths. The needle consists of a hollow needle (cannula) bonded to a clear hub at one end and a specific needle-point type (Quincke or Whitacre) at the other end. The stylet has a handle, which is color-coded and correlates to the gauge size.

The BD Spinal Needle Introducer consists of a needle, needle hub and needle shield and is available in various gauges. The needle consists of a hollow needle (cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle-point type at the other end. The introducer needle is optional aid through which a spinal needle can be inserted.

The BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer devices are single use, sterile needles which, incorporate the ISO 594-1 and ISO 594-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).

The document is a 510(k) summary for the BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the functional and biocompatibility tests. It indicates that the tests were performed according to specified ISO standards and internal requirements. Data provenance is not specified beyond the fact that these are non-clinical/design verification tests performed by BD. There is no indication of country of origin for any data or whether it is retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The tests performed are engineering and biocompatibility evaluations of physical device properties, not assessments requiring expert interpretation of clinical data in the same way an AI/ML device would.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of interpretations.

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

Not applicable. This is a 510(k) submission for conventional medical devices (needles), not an AI-assisted device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria in this submission is based on established engineering standards (e.g., ISO 594, ISO 7864, ISO 10993, USP) and internal company requirements for device functionality and safety. The performance is measured against these objective, predefined criteria rather than a subjective "ground truth" established by experts or clinical outcomes in the context of diagnostic accuracy.

8. Sample Size for Training Set

Not applicable. This is not an AI/ML device, therefore, there is no training set.

9. How Ground Truth for Training Set Was Established

Not applicable. There is no training set.

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Introducer for Endoscopic/Laparoscopic procedures.

The PMIPIN15 Percutaneous Introducer Needle is a single- use, disposable EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. The introducer sheath is 5 Fr and manufactured from low density polyethylene. The device is manually inserted by the physician during endoscopic and/or laparoscopic procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PMIPIN15 Percutaneous Introducer Needle.

The document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance data. Therefore, the "acceptance criteria" here are largely derived from the performance and characteristics of the predicate device and relevant international standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are essentially demonstrating equivalence to the predicate device and compliance with relevant standards. The "device performance" is presented as meeting these standards and being similar to the predicate.

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

The document does not provide specific sample sizes for the individual tests (biocompatibility, sterilization, package, mechanical performance). It states "A series of preclinical tests were performed" and refers to ISO and ASTM standards, which would dictate appropriate sample sizes for each test.

• Test Set Sample Size: Not explicitly stated (implied by compliance with standards).
• Data Provenance: The tests are non-clinical (laboratory-based, material-based). There's no human clinical data presented, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. Physical measurements and performance evaluations were done on samples of the new device and the predicate device. Needle penetration testing was conducted by an "independent lab."

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

Not applicable. This device's evaluation is based on non-clinical engineering and materials testing, not on interpretation by clinical experts. The "ground truth" for these types of tests comes from the established scientific methods and standards (ISO, ASTM).

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no clinical data or expert interpretation requiring adjudication. Performance is assessed against quantitative standards.

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

Not applicable. This is not an AI-powered diagnostic or assistive device. It is a physical percutaneous introducer needle.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• International Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11070 (needles), ASTM standards (packaging, shelf-life). These standards define acceptable methodologies and performance thresholds.
• Predicate Device Characteristics: For comparative aspects (design, materials, indications for use), the characteristics of the legally marketed predicate device (Ranfac Percutaneous Introducer PIN-15, K951090) serve as a de-facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

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

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

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

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The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.

The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.

The Aspire Introducer Needle, a single-use, sterile, non-pyrogenic, disposable product, underwent testing to ensure its reliable design and performance. The device is intended for guidewire introduction during percutaneous gastrointestinal procedures.

Here's a breakdown of the acceptance criteria and the study information:

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

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

The document does not specify the exact sample size for each performance test (e.g., bond strength, biocompatibility). It generally states that "test articles" were used, implying a sample was taken for each test. The provenance of the data is from internal testing conducted by Aspire Bariatrics, Inc. and is likely prospective in nature as it is part of the premarket notification process for a new 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 applicable. The device is a physical medical instrument, and its performance is evaluated through engineering tests, sterilization validation, and biocompatibility testing, not through expert-established ground truth on a dataset. The "ground truth" here is the adherence to established engineering specifications and regulatory standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study data where multiple experts interpret cases. For device performance testing, the results are typically objectively measured against predetermined acceptance criteria.

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

This information is not applicable. The Aspire Introducer Needle is a physical medical device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

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

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

The "ground truth" for the performance evaluation of this device is based on established engineering specifications, recognized industry standards (e.g., ISO 10993-1), and regulatory requirements for medical devices. This includes predefined strength limits for bond tests, successful sterilization, and documented biocompatibility.

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

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

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The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.

The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.

The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.

The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.

The provided text describes the B. Braun Tear-Away Introducer Needle and its substantial equivalence to a predicate device (Summit Medical Products, ambIT® Introducer) for FDA 510(k) clearance.

Based on the document, this is not an AI/ML device. It is a physical medical device (an introducer needle). Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

However, I can extract and present the information provided regarding the device's acceptance criteria and the (non-clinical) study that proves it meets them.

Device: B. Braun Tear-Away Introducer Needle

Type of Device: Physical Medical Device (Catheter Introducer/Introducer Needle) - NOT AI/ML

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO standards.

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The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system.

The Howell Biliary Introducer Needle is a modification to the Wilson-Cook Aspiration Biopsy Needle cleared to market via 510(k) K961897. The modified Howell Biliary Introducer Needle is a sterile, single use device that consists of a luer slip handle, outer catheter sheath, inner catheter with needle, stylet, syringe with stopcock, and MLLA hub. The Howell Biliary Introducer Needle is 200 cm long. The Howell Biliary Introducer Needle is introduced to the biopsy site through the Howell Biliary Introducer, covered by K961897. There have been no modifications to the Howell Biliary Introducer.

This document is a 510(k) premarket notification for a medical device, specifically the Howell Biliary Introducer Needle. It does not contain information about software or AI-enabled devices. Therefore, it does not have the kind of acceptance criteria or study details (like sample size, ground truth, expert qualifications, MRMC studies, or training sets) that would be relevant to an AI/ML-driven device.

The document discusses the substantial equivalence of modifications made to an existing predicate device (Wilson-Cook Aspiration Biopsy Needle). The performance data cited is related to design verification and validation testing, which is typical for hardware medical devices, not software performance.

Here's a breakdown based on the information provided, noting the absence of AI-specific details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance (e.g., sensitivity, specificity, or accuracy targets) as would be seen for an AI device. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process for medical devices, which focuses on demonstrating that modifications do not raise new questions of safety or effectiveness compared to a predicate device.

• Reported Device Performance:

  • The document states that "Design verification and/or validation testing was performed as a result of this risk analysis assessment."
  • "Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness."

  Note: This is a general statement about traditional medical device testing, not a report of specific performance metrics like those for an AI algorithm. The performance is deemed acceptable if it does not introduce new risks/issues compared to the predicate.

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

• Not applicable/Not provided. The document refers to "design verification and/or validation testing" for a physical medical device, not a test set for an algorithm. There is no data provenance information as it's not a data-driven study.

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

• Not applicable/Not provided. There is no "ground truth" establishment in the context of an AI algorithm's performance for this type of device submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a hardware device submission, not an AI device.

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

• No. This is a hardware device submission.

7. The Type of Ground Truth Used:

• Not applicable/Not provided.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. There is no training set for a physical medical device.

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

• Not applicable/Not provided.

Summary based on the provided document:

The document focuses on demonstrating substantial equivalence for the Howell Biliary Introducer Needle, a physical aspiration biopsy needle, to a legally marketed predicate device (Wilson-Cook Aspiration Biopsy Needle). The "acceptance criteria" are implicitly met by showing that minor design changes (material change for stylet, addition of syringe with stopcock, change in expiry date) do not negatively impact safety or effectiveness. This is confirmed through standard risk analysis (DFMEA) and design verification/validation testing appropriate for a hardware medical device. The document does not contain any information pertaining to AI or software-based performance studies.

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The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x 2.75 inch needle designed for percutaneous access to introduce a guidewire. The PinpointTM GT Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with PinpointTM GT Technology. The PinpointTM GT Introducer Needle, when used with the PinpointTM GT System creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes modifications to an introducer needle and asserts that the device meets acceptance criteria through various performance tests. However, it does not provide the detailed acceptance criteria and reported device performance in a table format, nor does it present a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement as requested.

The document is primarily a 510(k) summary for the Pinpoint™ GT Introducer Needle, arguing for its substantial equivalence to a predicate device (Pinpoint™ GT Safety Introducer Needle). It lists the types of tests conducted and the standards/guidance documents followed, but not the results against specific acceptance metrics.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract the information that is present and clearly state what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
However, the specific "predetermined acceptance criteria" and the "demonstrated performance" are not detailed in a table or any other format.

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

The document lists "Performance Testing - Bench" which implies physical bench tests of the device components.

• Sample size for test set: Not specified.
• Data provenance: Bench testing results, likely conducted internally by the manufacturer (C.R. Bard, Inc. / Bard Access Systems, Inc.). No information on country of origin of data, or if it was retrospective or prospective, as these are typically applicable to clinical studies, not bench tests like these.

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 the type of testing described (bench testing of a medical device's physical and functional properties). Ground truth and expert consensus are usually relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above (bench testing, not clinical evaluation requiring human reader 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

There is no indication of an MRMC study. The device is an introducer needle, not an AI diagnostic tool. While it interacts with an "ultrasound system equipped with Pinpoint™ GT Technology" to display a virtual image of the needle, the focus of this 510(k) is the needle itself and its substantial equivalence in physical and functional characteristics to a predicate device. The information provided does not suggest AI assistance for human readers in a diagnostic context.

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

This is not applicable. The device is a physical introducer needle, not a standalone algorithm.

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

As this involves bench testing of physical device attributes (e.g., tensile strength, dimensions, stiffness, echogenicity), the "ground truth" would be established by engineering and material standards, measurement tools, and physical inspection techniques to verify that the device meets its design specifications and relevant industry standards (e.g., ISO standards listed).

8. The sample size for the training set

This is not applicable. The context is the evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

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

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· SemiCut Semi-Automatic Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

· Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tisues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

Themy Automatic Biopsy Needle is also indicated to provide for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality.

· Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone.

· Easy Cut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone.

· MDL Biopsy Needle is intended for soft tissue core biopsy with Palium Reusable Automatic Biopsy Device. The device is not intended for use in bone.

· Coaxial Introducer Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

The M.D.L. S.r.l. Soft Tissues Biopsy Devices and Accessories include semi-automatic spring powered guns (disposable and reusable). Biopsy needle and cannula accessories are provided in a variety of sizes, designed to work with the manufacturer's semi-automatic guns to obtain and deliver a soft tissue core or aspirate sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.

The provided text details the 510(k) premarket notification for M.D.L. S.r.l. Soft Tissue Biopsy Devices and Accessories. This document demonstrates substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for an AI/algorithm-based device.

Therefore, most of the requested information (regarding expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, training set details, etc.) is not applicable to this document as it describes a clearance for a physical medical device (biopsy needles and devices), not a software or AI-driven diagnostic system.

However, I can extract information related to the acceptance criteria for the physical device performance and the tests performed to prove it, as presented in the document.

Here's the breakdown of what can be extracted and what is not applicable:

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

The document provides a "Performance Testing Summary" table (Table 2 on page 10) and describes the criteria and results in section 6.3 "Performance Testing".

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

• Sample Size: The document states, "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes for comparative testing to predicate devices for device performance." For specific tests like mechanical durability, penetration, activation force, and extraction, it notes that "Each tested subject and predicate device was activated 50 times" or "comparable over 50 shots per use," or "tested in triplicate" for shelf-life. There are no overall sample sizes for a "test set" in the context of clinical data for an AI model.
• Data Provenance: Not applicable as this is laboratory/bench testing of physical devices. The testing was conducted by M.D.L. S.r.l. in Italy, as indicated by the company's address. The data is from prospective bench testing performed specifically for this submission.

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

Not applicable. Ground truth, in the context of AI, refers to expert-annotated clinical data. This document describes the performance testing of physical biopsy devices, not a diagnostic AI algorithm. The "ground truth" here is the objective measurement of physical properties (e.g., force, distance, weight) performed by engineering testing.

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

Not applicable. This is not a clinical study involving human readers or interpretation of medical images.

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-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance testing of these physical devices was established through objective engineering measurements against predefined physical criteria, often compared to predicate devices. For example:

• Depth Projection: Measured movement of the needle.
• Penetration Force: Measured force using a dynamometer and certified testing foil.
• Sample Extraction: Measured weight of collected samples.
• Biocompatibility/Sterility/Pyrogenicity: Laboratory tests against international standards (ISO, USP).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's a physical device, not an AI/ML model.

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

Not applicable. See point 8.

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(N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination.

(N302) Coaxial Introducer Needle is used as a guiding needle for (N301)

The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded biopsy instrument with a biopsy needle fitted into a plastic handle.

The needle has a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.

The M-Biopsy™ Coaxial Introducer Needle has a trocar stylet and a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.

The device (M-Biopsy™ Semi-Automatic Biopsy Instrument) is sold as a single device and as a set combination (M-Biopsy™ Semi-Automatic Biopsy Instrument and M-Biopsy™ Coaxial Introducer Needle).

The M-Biopsy™ Semi-Automatic Biopsy Instrument is used to obtain multiple core biopsy samples from soft tissue such as the liver, kidney, prostate, breast, lymph nodes, etc.

The M-Biopsy™ Coaxial Introducer Needle is used as a guiding needle for the M-Biopsy™ Semi-Automatic Biopsy Instrument.

The M-Biopsy™ device family can be used as transient use less than 60 minutes.

The M-Biopsy™ device family is available from Gauge 14 to Gauge 20 in different lengths ranging from 6 cm to 30 cm.

The M-Biopsy™ Semi-Automatic Biopsy Instrument consists of: Mandrill, Needle, House Lit, House base, Spring bushings, Spring, Cannula sledge, Trigger, Protecting sheath and Silicone coating.

The M-Biopsy™ Coaxial Introducer Needle consists of: Mandrill, Needle, Luer, Hub, Stopper, Protecting sheath and Silicone coating.

The M-Biopsy™ Semi Automatic Instrument and Coaxial Needle (set combination) consists of the above mentioned parts and a 3 Cavity clips to keep the part in place in the pouch.

This document is a 510(k) premarket notification for a medical device called the "M-Biopsy Semi-Automatic Biopsy Instrument" and associated needles. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific clinical acceptance criteria for an AI or diagnostic device.

Therefore, the requested information about acceptance criteria and a study proving a device meets them (especially in the context of AI, multi-reader multi-case studies, standalone performance, and ground truth establishment) is not present in this document. This document describes a traditional medical device (a biopsy instrument) and its bench testing for mechanical and material properties, rather than a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

Here's what can be extracted based on the provided text, while acknowledging that it doesn't fit the typical "diagnostic device acceptance criteria" framework:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests and states that the device "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. Instead, it broadly states the device "conformed to and/or passed the testing standard."

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

The document mentions "Each product has been fired 10 times each" for the simulated biopsy performance test. It does not provide further details on the sample size for other mechanical tests or the "test set" in the context of a diagnostic device. Data provenance refers to bench testing, performed by the manufacturer, not clinical data.

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

Not applicable. This is a mechanical device, and "ground truth" in the diagnostic sense (e.g., expert consensus on images or pathology) is not established or reported. The tests conducted are physical and material property assessments.

4. Adjudication Method for the Test Set:

Not applicable. There is no expert review or adjudication process for the bench tests described. The tests are directly measured against predetermined criteria.

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

Not applicable. This is not a diagnostic device involving human readers interpreting images.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is not an algorithm or AI device. The performance refers to the physical function of the biopsy instrument.

7. Type of Ground Truth Used:

Not applicable in the diagnostic sense. The "ground truth" or reference standards for the tests performed are typically engineering specifications, material standards, and functional requirements for a biopsy device (e.g., consistent sample size, sufficient cutting force, sterility, biocompatibility). For the simulated biopsy test, the "form and length of the biopsy sample" was recorded, implying these were the measured outcomes compared against expected values or predicate performance.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set or associated ground truth.

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The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by Ultrasound Systems equipped with Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System creates a virtual image of the needle on the Ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Safety Introducer Needle, arguing for its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The document relates to a physical medical device (introducer needle) and the performance tests described are for the physical properties and safety of this device, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for the test set and data provenance for AI.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication method for AI.
• MRMC comparative effectiveness study results for AI.
• Standalone performance for an algorithm.
• Type of ground truth used for AI.
• Sample size for the training set for AI.
• How ground truth for the training set was established for AI.

The Pinpoint™ GT Safety Introducer Needle is a physical device, not an AI-powered diagnostic/predictive tool. The "Pinpoint™ GT Technology" mentioned is described as a passive magnet that interacts with an Ultrasound System to create a "virtual image of the needle on the Ultrasound display." This indicates a hardware-software integration for visualization, not an AI algorithm performing diagnostic interpretation or prediction.

What the document does provide regarding acceptance criteria and performance:

The document states that a series of verification and validation tests were performed "in accordance with Design Controls as per 21 CFR §820.30" and various ISO standards and guidance documents.
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."

Summary of Performance Tests (Bench, Biocompatibility):

Bench Tests:

• Dimensional Analysis
• Assembly Leak
• Hub to Cannula Bond Strength
• Needle Stiffness
• ISO Luer Compliance
• Guidewire Compatibility
• Safety Mechanism Override
• Visual Inspection
• Corrosion
• Usability and Simulated Use
• Blood Flash
• Echogenicity
• Magnet Testing
• Particulate testing (USP )

Biocompatibility Testing:

• Cytotoxicity
• Sensitization
• Intracutaneous
• Acute Systemic Toxicity
• Pyrogenicity
• Rabbit Blood Hemolysis
• Unactivated partial Thromboplastin Time Assay
• Dog Thrombogenicity

The document asserts that the device met the acceptance criteria for these tests (which would be defined by the referenced standards and internal protocols), thereby demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or detailed results of these tests are not provided in this summary document. It only states that the criteria were met.

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