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The Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate. It is not intended for use in bone.

The disposable biopsy needle is a sterile, spring loaded, disposable percutaneous soft tissue biopsy instrument. The disposable biopsy needle consists of a cannula, an inner stylet, a mechanical power device and a protective cover. It is used to obtain tissue samples for tissue biopsy, suitable for tissue biopsy of various organs such as the kidney, liver, prostate etc. The needle need to be inserted by a qualified physician under ultrasound guidance. The button of the mechanical power unit comply with the color coding requirements of ISO 6009, i.e. 18 gauge = Pink. The disposable biopsy needle includes three models: CMBNA/1810, CMBNA/1815, CMBNA/1820.

The provided text is a 510(k) clearance letter for a "Disposable Biopsy Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Therefore, many of the requested elements cannot be extracted from this document. However, I can provide what is available, noting where information is absent.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The document does not explicitly present a table of "acceptance criteria" against which a clinical device performance study was measured. Instead, it details that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. The performance data provided is primarily related to the physical and material characteristics of the device, rather than diagnostic accuracy or clinical outcomes.

Summary of Reported Performance (Non-Clinical):

Additional Requested Information:

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

   • Sample Size: Not specified for any "test set" in the context of clinical performance. For non-clinical functional testing, "24 repeated sampling steps" were conducted for functional reliability.
   • Data Provenance: Not specified for any clinical data. Non-clinical bench testing was conducted.

2. 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/Not provided. No clinical test set requiring expert ground truth was described.

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

   • Not applicable/Not provided. No clinical test set requiring adjudication was 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 a biopsy needle, not an AI-powered diagnostic tool.

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

   • Not applicable. This is a physical medical device (biopsy needle), not an algorithm.

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

   • Not applicable for clinical ground truth. For non-clinical sampling verification, the "mass and quality" of collected tissue samples were compared.

7. The sample size for the training set:

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

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

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

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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.

The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.

Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.

Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.

Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:

Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles

The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
• Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.

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

This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.

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

No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.

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

No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

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

• Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
• Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
• Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.

The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies.

The URAMIX CuraWay Automatic Core Biopsy Instrument is a medical device intended for obtaining biopsies from soft tissues. The provided text outlines a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., effect size of human readers, standalone performance, training set details) are not applicable or cannot be extracted from the given document as it primarily covers non-clinical engineering and design comparisons.

Here's an analysis of the provided information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of diagnostic performance metrics (like sensitivity, specificity, or AUC). Instead, it provides a comparison of engineering and functional characteristics to a predicate device, aiming to show substantial equivalence. The "performance" reported is primarily in relation to these comparative metrics.

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

The document mentions "ex-vivo tissue studies (porcine muscle, liver)" which suggests an experimental test set. However, it does not specify the sample size for these ex-vivo studies beyond stating "equivalent tissue samples." The data provenance is implied to be laboratory testing rather than human clinical data. No country of origin for this specific testing data is given, but the manufacturer is based in China. This is not a clinical study on patient data.

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. The comparisons and tests described are for physical and material characteristics of the device, not diagnostic performance requiring expert interpretation of results.

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

Not applicable. This device is not an imaging or diagnostic AI device requiring adjudication of human expert interpretations. The testing focuses on mechanical and material properties.

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. The URAMIX CuraWay Automatic Core Biopsy Instrument is a physical medical instrument (a biopsy needle), not an AI device or an imaging/diagnostic AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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-driven device.

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

For the ex-vivo tissue studies, the ground truth was implied by the objective measurements of sample length and weight taken from the porcine tissues. For other non-clinical tests (biocompatibility, sterility, etc.), the ground truth is compliance with recognized international standards (e.g., ISO, ASTM).

8. The sample size for the training set

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

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

Not applicable. No training set is relevant for this device.

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Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.

The Achieve Programmable Automatic Biopsy System is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic 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 Achieve® Programmable Automatic Biopsy Systems are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. The device provides precise control and quality sampling capability when working with calcified or fibrous lesions. The lightweight system offers spring-loaded action for fast, accurate penetration of dense tissue.

The provided document is a 510(k) premarket notification for the "Achieve Programmable Automatic Biopsy Systems." This submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical effectiveness with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria in terms of a clinical outcome (like diagnostic accuracy) is largely not applicable (N/A) in the context of this specific regulatory submission. The studies detailed primarily focus on engineering and performance specifications to establish equivalence, not clinical efficacy or diagnostic accuracy compared to a ground truth established by experts.

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are performance requirements for the device's function and safety, not clinical diagnostic accuracy. The reported performance is that the device "meets or exceeds all performance requirements."

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

Since this is a submission for a biopsy device demonstrating substantial equivalence through non-clinical performance testing (not clinical diagnostic accuracy), the concept of a "test set" and "data provenance" as typically applied to AI/diagnostic algorithms with patient data is N/A.

The non-clinical tests involved:

• Material properties testing: Evaluation of materials against industry standards.
• Sterilization validation: Testing of sterilization processes.
• Performance tests: Such as biopsy sample testing, weld strength, firing speed, and ultrasound visibility.
• Sample sizes for these engineering tests are not specified in this summary.
• Data provenance: Not directly applicable in the sense of patient data origin. These are laboratory-based engineering and performance tests.

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

N/A. The summary does not describe any studies involving experts establishing ground truth for diagnostic purposes. The "ground truth" for the non-clinical tests would be the established engineering standards, physical properties, or comparison to the performance of predicate devices.

4. Adjudication method for the test set

N/A. No adjudication method is described as there are no expert evaluations for clinical decision-making or diagnostic agreement.

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

N/A. This device is a biopsy instrument, not an AI diagnostic algorithm or imaging system. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

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

N/A. This is a medical device (biopsy system), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance studies would be:

• Engineering standards and specifications: For biocompatibility, residuals, material properties, sterilization efficacy, and packaging integrity.
• Performance metrics of predicate devices: For comparative tests like biopsy sample quality, weld strength, firing speed, and ultrasound visibility, where the proposed device's performance was compared to that of the legally marketed predicate devices to establish equivalency.

8. The sample size for the training set

N/A. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

N/A. Not applicable, as there is no training set for a physical biopsy device.

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