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The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Rubicor Breast Biopsy Device is 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

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The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary states:

• "Results of in-vitro testing demonstrate that the Rubicor Breast Biopsy Device is safe and effective for its intended function."

However, it does not provide details on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study (algorithm only) was done. (The device described is a physical biopsy instrument, not an AI algorithm).
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.

The Rubicor Flexible Loop Electrosurgical Electrode is 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

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The provided text describes a 510(k) premarket notification for the Rubicor Flexible Loop Electrosurgical Electrode. It details the device's intended use and claims substantial equivalence to predicate devices based on in-vitro testing. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study specifics.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (other than "in-vitro testing"). The document does not mention country of origin, nor whether the data was retrospective or prospective.

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 specified. The document only mentions "in-vitro testing," which typically doesn't involve human experts establishing ground truth in the same way clinical imaging studies do.

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

• Not applicable/Not specified as it was in-vitro testing.

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

• No. This document describes an electrosurgical electrode and its safety/effectiveness for tissue sampling. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant or mentioned.

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

• No. This device is a surgical instrument, not a standalone diagnostic algorithm. Its performance is tied to its physical function in tissue sampling.

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

• For "in-vitro testing," ground truth would typically refer to established physical or chemical properties, measurements, or the ability to perform the intended function (e.g., cut soft tissue, collect samples for subsequent histologic examination). The document implies the ability to provide tissue samples for histologic examination, but the specific "ground truth" for the in-vitro performance itself is not detailed.

8. The sample size for the training set

• Not applicable/Not specified. This is a conventional medical device, not an AI/machine learning model that would require 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.

Summary of Study:

The document states that "Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function." This indicates a study was conducted in a laboratory setting, likely involving tests to assess the device's ability to cut soft tissue and collect samples, as per its intended use for diagnostic sampling of breast tissue. The study aimed to show substantial equivalence to predicate devices like the Rubicor EnCapsule™ Breast Biopsy Device, SenoRx Shape Select Scalpel, Wallach LOOP Electrodes, and Megadyne Electrosurgical Electrode. However, no specific details about the methods, sample sizes, or precise outcomes of this in-vitro testing are provided beyond the general statement of safety and effectiveness.

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The Rubicor Magic ™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Rubicor Magic ™ Breast Biopsy Device is 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Rubicor Magic Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes an 8 cm long, 10 gauge, stainless steel coring cannula and a sharp stylet that runs through the center of the cannula and extends from its distal end. The handle of the device contains an actuation button, two indicator lights, a removable sample collection chamber, a drive mechanism for advancing and rotating the coring cannula and transporting the core specimen to the collection chamber, a DC motor, and a 9 V battery.

The provided 510(k) summary for the Rubicor Magic™ Breast Biopsy Device does not contain detailed acceptance criteria, specific study results, or information regarding a comparative effectiveness study (MRMC). The document states that "Results of in-vitro testing demonstrate that the Rubicor Magic Breast Biopsy Device is safe and effective for its intended function," and that the materials used meet ISO 10993-1 for biocompatibility. However, it does not provide quantitative performance metrics, sample sizes for test or training sets, details about ground truth establishment, or expert qualifications.

Based on the provided text, here is what can be extracted and what information is missing:

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

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

• Sample Size for Test Set: Not specified. The document only mentions "in-vitro testing."
• Data Provenance: Not specified. The testing is described as "in-vitro," which typically refers to laboratory-based testing rather than clinical data from human subjects.

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. As the testing was "in-vitro," it would not involve human experts establishing ground truth in the context of clinical images or pathological samples in the same way an AI diagnostic device would.

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

• Not applicable. This device is a biopsy instrument, not an AI diagnostic system requiring adjudication of interpretations.

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

• No. An MRMC study was not done. The device is a physical biopsy instrument, not an AI diagnostic system intended to assist human readers.

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

• Not applicable. This device is a physical biopsy instrument, not a standalone AI algorithm. The performance mentioned refers to the physical operation of the device (e.g., ability to core tissue, mechanism function).

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

• For "in-vitro testing," ground truth would likely refer to engineering specifications, mechanical performance targets, and material properties. The document does not specify the exact type of "ground truth" or reference standard used to evaluate the device's efficacy in obtaining diagnostic samples in the in-vitro setting. It does mention that the device is "designed to provide breast tissue for histologic examination," implying the ultimate goal is tissue suitable for pathology, but the "in-vitro" nature of the test means this wasn't tested with actual pathology outcomes from human biopsies.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not an AI system that requires a training set.

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

• Not applicable. This document describes a physical medical device, not an AI system.

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The EnCapsule Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The EnCapsule Breast Biopsy Device is 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Not Found

The provided document describes a Rubicor EnCapsule™ Breast Biopsy Device and its 510(k) submission to the FDA. Unfortunately, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "Results of in-vitro testing demonstrate that the Rubicor EnCapsule Breast Biopsy Device is safe and effective for its intended function." However, it does not provide specific acceptance criteria or quantitative performance metrics.

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

Not available in the provided text. The document only mentions "in-vitro testing" without detailing the sample size or the nature of the test set (e.g., human tissue samples, phantom, animal models). There is no information on data provenance (country of origin, retrospective/prospective).

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

Not applicable/available. Since the document only refers to "in-vitro testing" and does not describe a human-read or human-interpreted test set, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/available. As there's no mention of a human-interpreted test set, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

Not applicable. The device described is a physical breast biopsy device, not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type.

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

Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

Not explicitly stated due to limited information on the "in-vitro testing." For a physical biopsy device, the ground truth for performance would typically relate to the quality and adequacy of tissue samples obtained (e.g., tissue quantity, integrity, diagnostic yield). The document vaguely refers to "safe and effective for its intended function," implying that the in-vitro tests confirmed the device's ability to collect tissue for histologic examination.

8. The Sample Size for the Training Set

Not applicable/available. This is a physical device, not an algorithm that requires a training set.

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

Not applicable. As above, this is a physical device, not an algorithm.

In summary, the provided 510(k) summary is very high-level and only states that in-vitro testing was performed to demonstrate safety and effectiveness. It lacks specific details about the study design, acceptance criteria, sample sizes, ground truth establishment, or any human-reader involvement that would be needed to answer your questions comprehensively. The document focuses on establishing substantial equivalence to a predicate device (K023601 & K030049) based on intended use and method of operation, rather than providing detailed performance metrics of a novel study.

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The EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The EnCapsule Breast Biopsy Device is 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Not Found

The provided text is a 510(k) summary for the Rubicor EnCapsule™ Breast Biopsy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a modern AI/ML device submission would.

Therefore, much of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated. For this type of device (a biopsy device), acceptance criteria would likely revolve around mechanical performance, accuracy of tissue acquisition, safety (e.g., integrity of the device, absence of harmful interactions with the body), and biological compatibility.
• Reported Device Performance: The document states: "Results of in-vitro testing demonstrate that the Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function." However, no specific performance metrics (e.g., amount of tissue collected, success rate of biopsy, complication rates) are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: The study mentioned is "in-vitro testing," which typically means laboratory-based testing on non-human materials (e.g., tissue phantoms or excised tissue). No country of origin is specified. The nature of "in-vitro" suggests this would be a controlled environment rather than retrospective or prospective 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 as this is an in-vitro performance test for a mechanical device, not a diagnostic AI/ML algorithm requiring expert interpretation of medical images. Ground truth for a biopsy device would be related to its mechanical function, tissue recovery, and safety.

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

• Not applicable for an in-vitro performance test of a mechanical device.

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

• No. This is a breast biopsy device, not an AI/ML diagnostic tool meant for human reader assistance.

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

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

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

• For "in-vitro testing" of a biopsy device, ground truth would likely refer to objective measurements of the device's function, such as:
  • Confirmation of successful tissue acquisition (e.g., visual inspection, weighing tissue samples).
  • Mechanical integrity of the device before, during, and after use.
  • Absence of material degradation or unwanted interactions.
  • Compliance with design specifications.
  • No expert consensus, pathology, or outcomes data are mentioned for establishing ground truth of the device's performance in this context.

8. The 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. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical device (breast biopsy tool). It confirms that "in-vitro testing" was performed and deemed the device "safe and effective for its intended function," leading to a determination of substantial equivalence to predicate devices. However, it does not provide the detailed study results, acceptance criteria, or ground truth methodology that would be expected for an AI/ML device submission, due to the nature of the product.

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The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Rubicor EnCapsule™ Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with a partial or complete removal of the imaged abnormality.

The extent of histological 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 essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Not Found

The provided text describes a 510(k) summary for the Rubicor EnCapsule™ Breast Biopsy Device. However, the document does not contain a detailed study proving the device meets specific acceptance criteria for performance metrics analogous to those found in AI/ML device submissions (e.g., sensitivity, specificity, AUC).

Instead, this submission is for a physical medical device (an electrosurgical device for breast biopsies) and its substantial equivalence determination is based on a comparison to a predicate device and "in-vitro testing." The typical acceptance criteria for such a device would relate to its safety, effectiveness in sampling tissue, and functionality, rather than diagnostic accuracy metrics.

Here's a breakdown of the information that is available based on your request, highlighting what is missing due to the nature of the device and submission:

Acceptance Criteria and Reported Device Performance

Given the nature of this physical biopsy device, the "acceptance criteria" discussed are largely related to the device's functional performance and equivalence to a predicate, rather than diagnostic accuracy.

Study Details (as far as applicable to this type of device submission)

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

   • Test Set Sample Size: Not specified. The submission refers to "in-vitro testing." For a physical device, this would typically involve testing the device's mechanical, electrical, and functional attributes in a controlled environment, often not involving human patient data or a "test set" in the diagnostic AI sense.
   • Data Provenance: The testing was "in-vitro," meaning in a controlled lab environment. No information on country of origin or whether it was retrospective/prospective is provided, as it's not applicable to in-vitro testing of a physical device.

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

   • Not applicable. As this is not an AI/ML diagnostic algorithm, there is no "ground truth" established by experts in the context of diagnostic accuracy for a test set. In-vitro testing for a physical device might involve engineers or technicians evaluating device function against specifications.

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

   • Not applicable. There is no diagnostic "test set" or adjudication process described as would be for an AI/ML algorithm.

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:

   • Not applicable. This is a physical biopsy device, not an AI diagnostic tool designed to assist human readers.

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

   • Not applicable. This is a physical biopsy device, not a standalone AI algorithm. It is used by a human practitioner to obtain tissue samples.

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

   • Not applicable. For in-vitro testing of a physical device, the "ground truth" would relate to engineering specifications and functional output (e.g., successful tissue capture, integrity of the captured sample), not clinical diagnostic outcomes like pathology.

7. The sample size for the training set:

   • Not applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

   • Not applicable, as there is no training set.

Summary regarding the absence of detailed metrics common for AI/ML devices:

This 510(k) summary is for a physical medical device (a breast biopsy device) whose primary function is to collect tissue samples. The "test results" and "performance" section specifically refer to "in-vitro testing" demonstrating the device is "safe and effective for their intended function" and "substantially equivalent" to a predicate device.

The type of data and criteria you've asked for (e.g., sensitivity, specificity, expert ground truth, MRMC studies) are characteristic of diagnostic software or Artificial Intelligence/Machine Learning (AI/ML) devices. For a physical device like the Rubicor EnCapsule™, the "performance" typically refers to mechanical, electrical, and functional safety and efficacy, often assessed through bench testing and comparison to existing, legally marketed devices. The document does not provide any clinical study results demonstrating diagnostic accuracy metrics because the device itself is a tool for tissue acquisition, not a diagnostic algorithm. The diagnosis is made by a pathologist examining the tissue obtained using the device.

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The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Not Found

The provided text describes a 510(k) submission for the Rubicor EnCapsule™ Breast Biopsy Device. This device is classified as an electrosurgical device and accessories (21 CFR 870.4400) and is intended for diagnostic sampling of breast tissue during breast biopsy procedures. The submission is for a device in 2002, and at that time, 510(k) submissions were primarily focused on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with specific acceptance criteria and performance metrics as might be seen in later regulations or for higher-risk devices.

Based on the provided text, there is no detailed acceptance criteria or a study proving specific performance metrics in the way modern AI/software device submissions might include. The focus of this 510(k) is on safety and substantial equivalence.

Here's an analysis of the available information against your requested points:

1. Table of acceptance criteria and the reported device performance

• Safety and effectiveness
• Substantial equivalence to a predicate device | Performance: "Results of in-vitro testing demonstrate that Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function."
  Biocompatibility: "The materials used in the Rubicor EnCapsule™ Breast Biopsy Device have been shown to be biocompatible." |

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

• Sample Size: Not specified. The document only mentions "in-vitro testing."
• Data Provenance: Not specified.

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 submission focuses on in-vitro testing for a physical biopsy device, not on diagnostic performance where expert ground truth would typically be established for image interpretation.

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

• Not applicable. This is not a study assessing diagnostic accuracy 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

• No. This is a physical biopsy device, not an AI or imaging diagnostic aid.

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

• No. This is a physical biopsy device, not an AI or software algorithm.

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

• For the "in-vitro testing" and "biocompatibility" mentioned, the ground truth would be based on engineering specifications, laboratory standards, and material science principles rather than clinical outcomes or pathology for diagnostic accuracy. Specific details are not provided.

8. The sample size for the training set

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

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

• Not applicable.

Summary of Study (as described in the 510(k)):

The study described is not a clinical study in the sense of evaluating diagnostic performance against a ground truth. Instead, it's a submission demonstrating the safety and effectiveness of a physical medical device (a breast biopsy device) primarily through in-vitro testing and biocompatibility assessments. The core of the 510(k) process is to show substantial equivalence to a predicate device (Rubicor Breast Biopsy Device, K020047). The text only states that the in-vitro testing demonstrated the device is "safe and effective for its intended function" and that its materials are "biocompatible." No specific quantifiable acceptance criteria or detailed study results are provided in this summary.

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The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Rubicor Breast Biopsy Device

The provided text describes the 510(k) premarket notification for the Rubicor Breast Biopsy Device, focusing on its substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria, human readers, or ground truth.

Therefore, many of the requested categories cannot be populated from the given information.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not specify quantitative acceptance criteria for the device's performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to general safety and effectiveness.

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

• The document mentions "in-vitro testing," but does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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 as it focuses on device functionality and material safety, not diagnostic performance studies involving expert interpretation of results for ground truth.

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

• This information is not provided.

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

• This device is a biopsy device, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers using this device is not applicable and was not performed.

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

• This device is a biopsy device, not an algorithm or AI. Standalone algorithm performance is not applicable.

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

• The text states "Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use." This implies ground truth would be related to the physical characteristics of the tissue samples obtained (e.g., size, integrity, ability to be pathologically analyzed), but the specific type of ground truth (e.g., histological verification of tissue presence, size of biopsy core, cellular viability) is not detailed. It is not a diagnostic device relying on expert consensus or pathology on images, but a device to acquire tissue for pathology.

8. The sample size for the training set

• Training set information is not applicable as this is a physical medical device, not a machine learning algorithm.

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

• Ground truth for a training set is not applicable for this physical device.

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