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The EnCor Enspire™ Breast Biopsy System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.

The EnCor Enspire™ Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected breast abnormalities for diagnostic sampling. The EnCor Enspire™ Breast Biopsy System may be utilized with ultrasound, stereotactic, or MRI imaging guidance during the biopsy procedure. The EnCor Enspire™ Breast Biopsy System may be used with the EnCor™ Probes and EnCor™ Drivers. The EnCor Enspire™ Breast Biopsy System is reusable and provided non-sterile.

The EnCor™ Probe is a handheld biopsy probe used as part of a vacuum-assisted breast biopsy system. The EnCor™ Probe is meant to be used with an EnCor Enspire™ Breast Biopsy System or an EnCor™ Breast Biopsy System. The EnCor™ Probe is provided sterile and is intended for single use.

The EnCor™ Drivers are handheld units for ultrasound quided breast biopsies and for mounting on stereotactic platforms using adapters. The EnCor™ Drivers are reusable and provided nonsterile.

This document does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is an FDA 510(k) clearance letter and summary, which confirms that the device is substantially equivalent to a previously cleared predicate device.

Specifically, the document states:

• "The technological characteristics of the subject device are the same as those of the predicate device."
• "The subject devices and predicate are different in the following manner: Modifications to the Indication for Use Statement."
• "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted."

This clearly indicates that no new performance studies were conducted for this 510(k) submission to demonstrate the device meets acceptance criteria. The clearance is based on the substantial equivalence to the predicate device, and the only change (modifications to the Indications for Use statement) was deemed clerical and not affecting the device's design, safety, or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided FDA clearance documentation.

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The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It is intended 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 EnCor™ Breast Biopsy Probe with Rinse Tube is a handheld, single use, sterile (irradiation) biopsy probe used as part of a vacuum-assisted biopsy system (EnCor™ or EnCor Enspire™) and is intended to be used with ultrasound or stereotactic guidance. The probe is used for diagnostic sampling during a breast biopsy procedure. The device consists of a cutter/cannula with a sharp trocar tip, housing, sample container, vacuum and rinse tubing, and a rinse subcassette. A stainless steel cutter acquires the tissue samples, which are transported by vacuum to the probe's sample container, where they may be rinsed with saline. The EnCor™ Breast Biopsy Probe with Rinse Tube is available in 7 gauge, and 12 gauge, in both standard and vertical orientations for each qauge size.

This document is a 510(k) Premarket Notification from the FDA for the "EnCor Breast Biopsy Probe with Rinse Tube." As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the same way a clinical trial for a standalone AI algorithm would.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance metrics in the format you might expect for an AI algorithm. Instead, it lists performance testing summaries designed to show equivalence to a predicate device.

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

The document describes non-clinical tests performed on the device itself (e.g., vacuum testing, tensile testing), not on patient data. Therefore, there is no "test set" in the context of patient data, nor is there data provenance (country of origin, retrospective/prospective). The study is essentially an engineering verification and validation study comparing the new device to the predicate device and established performance standards.

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

Not applicable. This device is a physical breast biopsy probe, not an AI diagnostic tool. "Ground truth" in this context would relate to the physical properties and performance of the device components, which are typically assessed through engineering measurements and established test methods, not expert clinical consensus on images or pathology.

4. Adjudication Method

Not applicable. There is no clinical imaging or pathology data requiring adjudication.

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

Not applicable. This is a physical medical device, not an AI algorithm intended to assist human readers in interpretation.

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

Not applicable. This is a physical medical device. This term is relevant for AI algorithms.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering specifications, design requirements, and performance characteristics of the predicate device, as well as industry standards for medical device components and functionality. For example, a vacuum test would compare the device's vacuum pressure against a specified range or the predicate's measured pressure.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for a physical medical device.

Summary of the Study:

The study described is a non-clinical performance testing summary aimed at demonstrating substantial equivalence to a predicate device per FDA 510(k) requirements. The tests performed were engineering-based evaluations of the physical device's functionality, such as "Cassette functionality and switch activation," "Vacuum testing," "Rinse testing," "Tensile testing," "Sub-cassette reliability," and "Packaging validation." These tests likely involved comparing the performance of the new device to pre-defined specifications and/or the performance of the predicate device. The conclusion is that the device's technological characteristics and performance are "comparable" to the predicate, making it as safe and effective.

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The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture.

The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of AI/ML, clinical performance, or diagnostic accuracy. Instead, the document is a 510(k) premarket notification for a medical device (EnCor® MRI Introducer Set, EnCor® Probe Introducer) with a summary of changes and performance testing.

The key points from the provided text are:

• Device: EnCor® MRI Introducer Set, EnCor® Probe Introducer.
• Purpose: These devices are used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway for diagnostic biopsy.
• Regulatory Submission: This is a 510(k) submission for a change in the printing ink material used on the outer cannula of the device.
• Predicate Device: SenoRx, Inc. Introducers (K042098).
• Performance Testing Summary (related to the change):
  • Biocompatibility testing of the new ink (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogen Testing).
  • Functional testing after Accelerated Shelf Life and T=0 (Ink adhesion and ink adhesion IPA wiping).
• Conclusion: The testing demonstrated that the technological characteristics and performance criteria of the EnCor® Introducers are comparable to the predicate device, and it performs as safely and effectively.

Based on the nature of the document, which pertains to a minor material change in an accessory device and its substantial equivalence to a predicate, the typical elements you requested (like AI/ML performance, sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable or present.

Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study proving device performance using those criteria, as the document focuses on regulatory approval for an updated component (ink) of a physical medical device, not a diagnostic AI/ML algorithm.

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The Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

The StarchMark® Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker. The marker contains six polysaccharide (starch) pellets and one polylactic/polyglycolic acid-based copolymer (PLA/PGA) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PLA/PGA pellet contains a Stainless Steel Ribbon or "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark® Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.

The StarchMark UltraCor™ Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains four polysaccharide (starch) pellets and one polyethylene glycol (PEG) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PEG pellet contains a Stainless Steel "V" shaped wireform. The wireform is intended for longterm radiographic marking of the biopsy site. The StarchMark UltraCor™ Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.

This submission for K131654, for the StarchMark® Breast Tissue Marker and StarchMark UltraCor™ Breast Tissue Marker, is a Special 510(k) for a device modification. This type of submission is used when changes to a legally marketed device do not affect the fundamental scientific technology of the device and do not raise new questions of safety or effectiveness.

In this specific case, the only modification is to the labeling, specifically moving a statement regarding allergic reactions from the warnings section to the contraindications section. Because the change does not affect the device's design, materials, performance specifications, packaging, or sterilization, no new performance testing was deemed necessary or performed to demonstrate that the device meets acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not applicable to this particular 510(k) submission. There is no new study performed to demonstrate device performance against acceptance criteria for this modification.

Here's a breakdown of what can be derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. No new performance testing was conducted for this Special 510(k) modification. The basis for substantial equivalence relies on the unchanged design and performance of the predicate device.

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

Not applicable. No new test set or data provenance details are provided as no new performance testing was performed.

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

Not applicable. No new ground truth establishment process was needed as no new performance testing was performed.

4. Adjudication Method for the Test Set:

Not applicable. No new test set or adjudication method was used.

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

No. An MRMC study was not done. This type of study would typically be conducted for new diagnostic devices where human reader performance is a key metric. This submission is for a tissue marker, and the modification does not relate to diagnostic performance.

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

No. This device is a physical tissue marker, not an algorithm, so standalone performance testing in this context is not applicable.

7. The Type of Ground Truth Used:

Not applicable. No new ground truth was established for this modification. The device's safety and effectiveness were previously established through the predicate device's clearance.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a training set as it's a physical medical device, not an AI or machine learning algorithm.

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

Not applicable. As above, there is no training set for this device.

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The EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 EnCor Breast Biopsy System with its 7 and 10-Gauge biopsy probes has the following similarities with the predicate devices: same intended use; same design; same patient contacting materials; same operating principle; and same technological characteristics.

This 510(k) summary (K093512) for the SenoRx EnCor Breast Biopsy System does not contain a description of acceptance criteria or a study proving that the device meets specific performance criteria in the way a diagnostic or AI-enabled device submission would.

Instead, this submission is for a biopsy device and focuses on establishing substantial equivalence to previously cleared predicate devices, particularly for an expanded indication for use (palpable abnormalities). For a device like this, the assessment is typically based on design, operating principle, materials, and intended use being similar to existing cleared devices, rather than measuring performance against a predefined numerical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable or not present in this type of submission for a physical biopsy device.

Here's a breakdown of the available information based on your request, highlighting what is included and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a biopsy device. The basis for clearance is substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.

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

Not applicable. There is no mention of a "test set" in the context of evaluating performance for this device, as the submission relies on substantial equivalence.

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

Not applicable. There is no "ground truth" to be established by experts for performance evaluation in this submission. The device's function is to collect tissue, and its equivalence is deemed sufficient by comparison to predicates.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-enabled device or an image analysis device that would be subject to MRMC studies. It is a physical biopsy instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

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

7. The Type of Ground Truth Used

Not applicable. As this is not a diagnostic device assessing an outcome, there isn't a "ground truth" in the typical sense of a diagnostic study (e.g., pathology, outcomes data). The basis for the device's function is its ability to retrieve tissue, and its safety and effectiveness are established via substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not a machine learning or AI algorithm.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Submission's Approach:

The 510(k) K093512 for the EnCor Breast Biopsy System establishes substantial equivalence to predicate devices (KNW K040842, K003297, K030472, K051158). The key argument for substantial equivalence is based on the following similarities:

• Same intended use (with a modification to include palpable abnormalities, which is justified by matching predicate device indications).
• Same design.
• Same patient contacting materials.
• Same operating principle.
• Same technological characteristics.

This approach allows the device to be marketed without requiring new clinical performance studies or specific numerical acceptance criteria, as its safety and effectiveness are inferred from the safety and effectiveness of the legally marketed predicate devices.

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The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.

The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size.

The provided text describes the 510(k) summary for the SenoRx Contura Cavity Maintenance Catheter. It outlines the device's purpose, its equivalence to a predicate device, and the performance testing conducted. However, it does not contain the specific information requested about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or details of a multi-reader multi-case study.

The document is a regulatory submission for device clearance, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to populate the table and answer the questions based only on the available information, noting where information is absent:

1. Table of Acceptance Criteria and 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 the test set: Not provided.
• Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The testing appears to be preclinical (bench and in vivo), not human clinical 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)

This information is not provided. The testing described is preclinical (dimensional stability, burst volume, durability, biocompatibility), which typically does not involve expert consensus for ground truth on clinical images or diagnoses.

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

This information is not provided. As the testing appears to be preclinical and does not involve human interpretation of clinical data in a diagnostic context, an adjudication method for a test set is not applicable or 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described. This device is a physical medical device (catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.

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

No, a standalone study was not done or described. This device is a physical medical device (catheter) and not a software algorithm.

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

For the preclinical tests described (dimensional stability, burst volume, in vivo durability, biocompatibility), the "ground truth" would be established by objective measurements and laboratory standards for physical and material properties, as well as biological responses in an in vivo setting (likely animal models for some aspects of durability/biocompatibility) against predetermined specifications. It's not based on expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set

This information is not provided. This device is a physical medical device and would not typically have a "training set" in the context of an algorithm or AI.

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

This information is not provided. As above, the concept of a "training set" and its "ground truth" is not applicable to the preclinical testing of this physical medical device.

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The Contura Lumen Marker is an accessory to the Contura MLB Applicator intended to be used to identify treatment lumens for radiation therapy dose planning.

Re-usable devices that aid in the identification of lumens within the Contura MLB Applicator. Each marker is 237 mm in length.

The provided document describes the Contura Lumen Marker, an accessory for the Contura MLB Applicator, used to identify treatment lumens for radiation therapy dose planning. This device is not an AI/ML powered device, and therefore the majority of the requested information regarding AI/ML studies is not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, the concept of "acceptance criteria" is typically tied to functional performance and safety, rather than diagnostic accuracy metrics. The document summarizes "preclinical testing" rather than formal performance studies with explicit acceptance criteria and corresponding reported device performance values as would be seen for a diagnostic or AI/ML device.

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

Not applicable for this type of device. The document mentions "preclinical testing" but does not specify a "test set" in the context of diagnostic performance. The testing would have involved prototypes of the marker and applicator.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. The assessment of compatibility, CT visibility, and durability would likely be conducted by engineers and medical physicists, but these are not "experts" establishing a diagnostic ground truth.

4. Adjudication Method

Not applicable. This is not a diagnostic device requiring adjudication of different expert opinions.

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

No. This device is not an AI/ML system and does not involve human readers interpreting images.

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

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The "performance" of this device is assessed by its physical characteristics and functionality, not by its ability to accurately identify or diagnose a condition. The "ground truth" would be established by direct observation and measurement of its physical properties and interactions with the Contura MLB Applicator and CT imaging.

8. Sample Size for the Training Set

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

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

Not applicable.

Summary of Device and Evidence Presented:

The K082264 submission for the Contura Lumen Marker is focused on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics through extensive clinical or diagnostic studies. The "Summary of substantial equivalence" section highlights the "preclinical testing" conducted, which assessed:

• Marker compatibility with the Contura MLB Applicator: This would involve testing if the marker fits and functions correctly within the applicator.
• CT visibility: This would involve imaging the marker within the applicator using a CT scanner to ensure it is clearly visible for radiation therapy dose planning.
• Durability: This would involve testing the marker's ability to withstand repeated use or conditions it is expected to encounter.

The document states that the Contura Lumen Marker "performed as intended" in these preclinical tests. The primary argument for substantial equivalence is based on the device having the "Same intended use; Same design; Same materials; Same operating principle; Same technological characteristics" as its predicate devices.

Conclusion:

The provided document describes a physical medical device (Contura Lumen Marker) that aids in radiation therapy planning. The regulatory submission (510(k)) focuses on demonstrating substantial equivalence to existing devices through preclinical testing of its physical and functional properties, rather than diagnostic accuracy studies or AI/ML performance evaluations. Therefore, most of the requested information regarding AI/ML study components is not pertinent to this device.

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The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

The StarchMark Biopsy Site Marker is a sterile, disposable applicator containing 4 resorbable polysaccharide (starch) pellets and a polylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with an embedded radiopaque wireform.

The provided text describes a 510(k) summary for the StarchMark Biopsy Site Marker. It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain specific acceptance criteria or the details of a study structured to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which would typically be found in performance studies for diagnostic devices.

Instead, the submission focuses on preclinical studies and biocompatibility testing to demonstrate safety and functional aspects under simulated use conditions and to meet ISO 10993-1 requirements. The "study" mentioned is primarily a comparison to a predicate device for substantial equivalence.

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

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

No explicit acceptance criteria with specific quantitative thresholds (e.g., sensitivity, specificity, accuracy) are provided in the document for the StarchMark Biopsy Site Marker in terms of diagnostic performance. The document focuses on demonstrating substantial equivalence to an existing predicate device (K031938; Gel Mark III Biopsy Site Marker).

The "performance" is reported in terms of:

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 for Test Set:
  • For in vitro laboratory studies: Not specified.
  • For biocompatibility testing: Not specified.
  • For the porcine study: Not specified.
• Data Provenance: Not specified. The document does not mention the country of origin of data or whether studies were 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)

This information is not provided in the document. The studies mentioned (in vitro, biocompatibility, porcine bleeding control) do not involve human expert interpretation for establishing a "ground truth" in the diagnostic sense.

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

This information is not provided. As the studies described do not involve human diagnostic interpretation for a test set, adjudication methods are not applicable here.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported.
• Effect Size of AI assistance: Not applicable, as this device is a biopsy site marker and not an AI-powered diagnostic tool. The document describes a medical device, not an AI algorithm.

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

• Standalone Study: This question is not applicable as the StarchMark Biopsy Site Marker is a physical medical device, not a standalone algorithm.

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

The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., against pathology for cancer detection) is not directly applicable to the reported studies.

• For in vitro studies: Performance "as intended" under simulated use implies comparison against pre-defined functional specifications.
• For biocompatibility: ISO 10993-1 standards serve as the "ground truth" or benchmark.
• For the porcine study: "Cessation of bleeding time" in the control group served as a comparative "ground truth" for evaluating superiority.

8. The sample size for the training set

This information is not applicable as the described studies are not for training an algorithm.

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

This information is not applicable as the described studies are not for training an algorithm.

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The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.

The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Ga disposable beveled needle applicator. Also contained in the needle are 2 resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks.

This is an FDA 510(k) premarket notification for the SenoRx Prostate Tissue Marker. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria.

Therefore, many of the requested categories for a comprehensive performance study (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included or required in a 510(k) summary focused on substantial equivalence.

Based on the provided document, here's the information that can be extracted or deduced:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission focuses on demonstrating that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

The "performance" described is largely based on the equivalence to 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 provided. The 510(k) summary does not detail a clinical test set or study with specific sample sizes. Substantial equivalence is demonstrated through comparison to predicates, material characterization, and potentially bench testing, not typically through a clinical performance study with a 'test set' as defined for AI/software.

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 ground truth establishment for a clinical test set is described.

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

Not applicable. No clinical test set and related adjudication method are 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 a tissue marker device, not an AI or software device.

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

Not applicable. This is a tissue marker device, not an AI or software algorithm.

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

Not applicable. No ground truth is described in the context of a performance study in this 510(k) summary. The "ground truth" for the device's function is its physical presence and radiopacity as observed in imaging, and its biocompatibility, which would have been assessed through preclinical testing (not detailed in this summary).

8. The sample size for the training set

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

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

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

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The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

The Contura MLB Applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four lumens symmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6 cm spherical shape by a controlled volume injection of a saline/contrast solution.

This document is a 510(k) summary for the Contura MLB Source Applicator for Brachytherapy, which is a medical device. This is NOT a study describing device performance against acceptance criteria in the typical sense of a clinical or statistical study with acceptance criteria often seen for AI/ML devices.

Instead, the document details preclinical studies demonstrating the device's intended performance under simulated use conditions and its dosimetry equivalence to predicate devices. The "acceptance criteria" here are generally implied as meeting the functional requirements for a remote-controlled radionuclide source applicator and demonstrating similar radiation dose distribution to already cleared devices.

Here's an attempt to structure the information based on your request, understanding that this is a device submission and not a typical performance study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of human subjects or data sets for an AI/ML device. The "test set" would refer to the physical device prototypes or simulations. The document does not specify the number of devices or simulated scenarios tested in the preclinical studies.
• Data Provenance: Not applicable. The "study" refers to internal preclinical testing conducted by SenoRx, Inc.

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

• Not applicable as this is not a diagnostic AI/ML device relying on expert-established ground truth from images or clinical data. The "ground truth" here would be established by engineering and dosimetry measurements and comparisons. Experts involved would be engineering, physics, and potentially clinical personnel involved in designing and testing the device. Their number and qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of adjudication for "test sets" in the context of human expert disagreement on classifications. Adjudication methods are typically relevant for human-interpretable data where ground truth is ambiguous or requires consensus.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical instrument, not a diagnostic AI/ML algorithm that assists human readers.

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

• Not applicable. This is not an AI/ML algorithm. The "standalone" performance refers to the device's functional and dosimetric performance on its own, which was evaluated through preclinical studies.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation was primarily based on engineering measurements, physical properties, simulated use conditions, and dosimetric calculations/measurements. This would involve:
  • Functional tests: Verifying inflation mechanics, lumen patency, compatibility with afterloaders.
  • Material properties: Ensuring biocompatibility and structural integrity.
  • Dosimetry: Measuring or calculating radiation dose distribution and comparing it to known predicate devices and established radiation physics principles.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that uses a "training set." The development of the device would involve engineering design, prototyping, and testing, which isn't analogous to training data.

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

• Not applicable. There is no "training set" for this device.

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