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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end -- a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

This 510(k) summary provides information about the Neothermia Corporation's en-bloc Biopsy System™, a device for diagnostic sampling of breast tissue. However, it does not contain the specific acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.

This document describes a traditional medical device (electrosurgical generator and biopsy instrument), not an AI/ML powered device. The "Substantial Equivalence" section focuses on comparing its "intended use, principles of operation, and technological characteristics" to previously cleared predicate devices, specifically "Neothermia's cleared 10mm, 15mm and 20mm en-bloc probes," with an emphasis on a "material change" in the new probe.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of 510(k) submission.

I will address the questions based on the information available and indicate when information is not present or not relevant to this type of device submission.

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

This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, the criterion for clearance is substantial equivalence to predicate devices.

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

Not applicable or not provided. This 510(k) submission for a non-AI/ML device typically does not include a test set sample size or data provenance in the context of an accuracy study. Substantial equivalence is often demonstrated through engineering testing, biocompatibility, sterilization validation, and comparison of design features and intended use.

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 an AI/ML algorithm's performance on clinical data, is not established for this type of device submission.

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

Not applicable. Adjudication methods are not described for this type of medical device submission.

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. An MRMC study is not relevant for this traditional electrosurgical biopsy system.

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

Not applicable. This device is not an algorithm; it is a physical electrosurgical system requiring human operation.

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

Not applicable. The concept of "ground truth" for evaluating an algorithm's diagnostic performance is not applied in this type of 510(k) submission for a physical device. Performance is generally assessed through functional testing, safety testing, and comparative analysis against predicate device specifications.

8. The sample size for the training set

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

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

Not applicable. As there is no training set for an AI/ML algorithm, ground truth establishment for a training set is not relevant.

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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

This document is a 510(k) Pre-market Notification for the Neothermia Corporation's en-bloc Biopsy System™. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device or algorithm.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission.

Here's an analysis based on the provided text, highlighting what is and isn't present:

Key Takeaway: This 510(k) submission is for a modified version of an already cleared device ("modified cradle") and aims to show it has the "same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices." It explicitly states, "The change does not raise new questions of safety or efficacy." This type of submission does not typically include new performance studies with specific acceptance criteria in the way a novel device or AI algorithm would.

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

• Not Applicable. This submission is based on substantial equivalence to predicate devices, not on proving new performance against defined acceptance criteria with reported metrics. The document asserts that the modified device has the "same intended use, principles of operation, and technological characteristics" as existing cleared predicate devices.

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

• Not Applicable. No specific test set data is described for performance evaluation in this 510(k) summary. Given it's a "modified cradle" and not a fundamentally new device, performance testing (if any) would likely be limited to verification and validation of the modification's impact, not a full-scale clinical or diagnostic accuracy study.

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. No test set requiring expert-established ground truth is described.

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

• Not Applicable. No test set is described.

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 an electrosurgical biopsy system, not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not Applicable. This is a hardware device (electrosurgical biopsy system). There is no "algorithm only" component to test for standalone performance in the context of diagnostic accuracy.

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

• Not Applicable. No specific ground truth establishment for a performance study is mentioned in this submission. The device itself is intended for diagnostic sampling of breast tissue, implying that the tissue samples it yields would then be subject to pathology for definitive diagnosis.

8. The sample size for the training set

• Not Applicable. This is an electrosurgical device, not a machine learning algorithm. Therefore, there is no "training set."

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

• Not Applicable. No training set is involved.

Summary regarding acceptance criteria and studies:

The provided text from the 510(k) summary emphasizes substantial equivalence to predicate devices. The core argument is that the "modified cradle" of the en-bloc Biopsy System™ retains the "same intended use, principles of operation, and technological characteristics" as previously cleared devices, and that the modification "does not raise new questions of safety or efficacy."

Therefore, this document does not contain information about:

• Specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
• Clinical studies or diagnostic accuracy studies with sample sizes, data provenance, ground truth establishment, or reader performance metrics.
• Any AI-related performance metrics or studies.

The "study" implicitly referenced is the comparison to predicate devices, demonstrating that the modified device is similar enough not to warrant new, extensive performance studies typically required for novel devices.

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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

The provided text is a 510(k) summary for Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use and technological characteristics, as well as its substantial equivalence to previously cleared predicate devices. However, it does not include information about specific acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as the provided document does not contain acceptance criteria or study results.

The document is purely a regulatory submission declaring substantial equivalence to predicate devices, which means it argues that the new device is as safe and effective as existing legally marketed devices, rather than presenting new performance data against specific criteria.

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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System and an FDA clearance letter. It focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way a clinical trial report or a comprehensive validation study would.

Therefore, I cannot provide the requested information in the format you specified. The document explicitly states that "The dimensional change does not raise new questions of safety or efficacy. The modified probe is substantially equivalent to Neothermia's cleared en-bloc probes." This indicates that the clearance was based on equivalence to existing devices rather than new performance data against specific acceptance criteria.

Here's why each point you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence based on intended use, principles of operation, and technological characteristics, not on quantitative performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not present. No test set or associated data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method for the test set: Not present. No adjudication is described.
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 present. This device is an electrosurgical biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not present.

In summary, the provided 510(k) summary and FDA clearance letter do not contain the type of detailed performance data and study information you requested because the clearance was granted based on substantial equivalence, not a de novo pathway requiring extensive new performance data against specific acceptance criteria.

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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.

This submission (K021577) is a 510(k) premarket notification for the Neothermia Corporation's en-bloc Biopsy System™. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria in the manner one might find for a novel AI/software component within a medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria related to a performance study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment.

The document discusses:

• The intended use of the device ("diagnostic sampling of breast tissue during a breast biopsy procedure").
• Its technological characteristics (percutaneous high frequency, automated, vacuum-assisted electrosurgical device for tissue removal).
• The components of the system (hand-held biopsy handle, single-use probe with electrodes, cannula, plastic sleeve, vacuum).
• The basis of substantial equivalence: The 15mm en-bloc probe has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices (Neothermia's 10mm and 20mm en-bloc probes).
• A minor difference in technological characteristics (size of basket) is noted, but the submission claims this "does not raise new questions of safety or efficacy."

Conclusion:

Based on the provided text, it is not possible to extract the detailed information requested about acceptance criteria and a performance study. The submission relies on establishing substantial equivalence to existing devices, implying that the safety and effectiveness are supported by the predicate devices, not a new clinical performance study within this document.

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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the single use disposable Probe is attached, with an integral cable to connect the handle to the en-bloc Electrosurgical Generator. The Probe contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. A plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure.

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use, technological characteristics, and a performance study. However, it does not provide specific acceptance criteria in a quantifiable manner, nor does it detail a study that explicitly "proves the device meets acceptance criteria" with the level of detail requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methodology as typically seen in AI/diagnostic device studies).

This submission focuses on demonstrating substantial equivalence to predicate devices, particularly the ability to obtain viable tissue samples for pathology, rather than statistical performance against predefined clinical metrics.

Here's an attempt to extract the information you requested based on the limited data, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the stated purpose of the performance testing and the general concept of substantial equivalence for a biopsy device. No quantitative thresholds (e.g., "capture rate > 95%", "fragmentation rate < 2%") are provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated, but the testing was conducted "on porcine tissue."
• Data Provenance: Porcine tissue (animal model). The data is likely prospective as it was collected for the purpose of this evaluation. The country of origin of the porcine tissue is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the evaluation mentions "pathology evaluation" and "histopathologic examination," implying that pathologists or histotechnicians would have been involved in assessing the suitability of the specimens.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the "pathology evaluation," it likely involved one or more experts assessing the tissue samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a device for tissue extraction, not an interpretation aid for diagnostic imaging, which is where MRMC studies are typically employed for AI products.

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

• Standalone Performance: Not applicable. This is a physical biopsy device, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was based on the histopathologic examination of the excised porcine tissue. This assessed whether the specimens were "intact, unfragmented," had a "predictable diameter and length," and were generally "suitable for post-biopsy histopathologic examination."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/algorithm that requires a training set. The performance testing was for the physical device's cutting and capture capabilities.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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