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

The Presto 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 Presto Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes a stainless steel coring cannula with a razor edge and a stationary coil located within the coring cannula. The handle of the device contains an actuation button, a sample collection chamber, a drive mechanism for rotating the coring cannula and a DC power jack for a 12V input. A reusable, medical grade AC/DC power supply provides 12V to the disposable device. Depressing the button on the handle rotates the coring cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device is used with a coaxial introducer. Actuating the partoff button mechanically adjusts the distal end of the coring cannula between a coring & partoff configuration.

Here's an analysis of the acceptance criteria and study information for the Presto Breast Biopsy Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" in the context of a clinical study or human performance evaluation. The performance data presented are from non-clinical studies.

• Sample sizes mentioned for non-clinical tests:

  • Test #2 (Tissue not cored/transported): "Mass of 5 samples > 0.13g"
  • Test #8 (Systemic Toxicity): "none of the test extract animals exhibit a significantly greater reaction than the corresponding control animals; b) no more than one animal dies; c) no more than 1 animal displays abnormal behavior... and c) no more than 2 animals display a body weight loss > 2 grams."
  • Test #10 (Pyrogenicity): "each of the three animals does not experience a temperature rise ≥ 0.5°C"
  • Test #14 (Partoff tab actuated prematurely): "Mass of 5 samples > 0.13g"

• Data Provenance: The studies are described as "non-clinical performance data" and include "ex-vivo device performance," "tensile strength & fatigue," "biocompatibility," and "simulated use testing." This indicates the data is from laboratory and bench testing, rather than retrospective or prospective human data from a specific country of origin.

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

Not applicable. The reported studies are non-clinical (bench testing, simulated use, biocompatibility). There is no mention of a "test set" requiring expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. As the studies are non-clinical and do not involve human readers or interpretation of medical images/data, no adjudication method is mentioned or required.

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. The document focuses solely on non-clinical performance data and a substantial equivalence comparison to predicate devices, not on human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not mentioned. The device described is a physical medical instrument (a breast biopsy device), not an artificial intelligence algorithm. The device's performance is evaluated based on its mechanical function and material properties.

7. The Type of Ground Truth Used

For the non-clinical studies described, the "ground truth" is established by:

• Engineering specifications and measurements: For mechanical tests like compression, weld force, and cycling tests (e.g., tube must withstand >15lbf, mass of samples > 0.13g, tab must last >30 cycles).
• Standardized biological/chemical assays: For biocompatibility tests, following ISO 10993 standards (e.g., cell reactivity, sensitization, irritation scores, hemolytic index, temperature rises in animal models).

This is not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data, as it is a non-clinical device evaluation.

8. The Sample Size for the Training Set

Not applicable. This document describes the evaluation of a physical medical device (biopsy device), not an AI algorithm that would require a training set.

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

Not applicable. As there is no AI algorithm or training set discussed, there is no mention of how ground truth was established for such a set.

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The Presto 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 Presto 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 Presto Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes a stainless steel coring cannula with a razor edge and a stationary coil located within the coring cannula. The handle of the device contains an actuation button, a sample collection chamber, a drive mechanism for rotating the coring cannula and a DC power jack for a 12V input. A reusable, medical grade AC/DC power supply provides 12V to the disposable device. Depressing the button on the handle rotates the coring cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device may be used with a coaxial introducer.

The Presto Breast Biopsy Device, as per the provided information, is a medical device for diagnostic sampling of breast tissue. The submission focuses on its equivalence to predicate devices and its ability to meet established specifications through non-clinical studies.

Here's an analysis of the provided text in relation to the requested information:

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)

The provided document describes non-clinical studies (in-vitro device performance, electrical & product safety, tensile strength & fatigue, biocompatibility, predicate device comparison, and simulated use testing). There is no information provided regarding a clinical test set involving human subjects. Therefore, details about sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.

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)

Since the provided information focuses on non-clinical studies and does not describe a clinical test set with a ground truth established by experts, this information is not applicable / not provided in the document.

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

As there is no clinical test set described, an adjudication method for human readers is not applicable / not provided in this documentation.

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

The document describes a medical device (a breast biopsy device), not an AI assistance system for human readers. Therefore, an MRMC comparative effectiveness study regarding human readers and AI assistance is not applicable / not provided.

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

This device is a physical breast biopsy instrument, not an algorithm. Therefore, a standalone algorithm performance study is not applicable / not provided.

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

For the non-clinical studies performed, the "ground truth" would be engineering specifications, material properties, electrical safety standards, and functional requirements. For example:

• In-vitro device performance: Performance against pre-defined metrics (e.g., tissue sample size, cutting efficiency) in a controlled environment.
• Electrical & product safety: Compliance with IEC 60601-1 standards.
• Tensile strength & fatigue: Material science standards for strength and durability.
• Biocompatibility: ISO 10993 standards for biological safety.
• Predicate device comparison: Direct comparison of features, materials, and functionality with existing legally marketed devices.
• Simulated use testing: Performance against expected operational parameters in a simulated environment.

There is no mention of ground truth related to human clinical outcomes (e.g., pathology confirmed diagnoses) in this non-clinical submission.

8. The sample size for the training set

The document describes non-clinical testing for a physical device. It does not mention a "training set" in the context of machine learning or AI models. This concept is not applicable / not provided for this type of device submission.

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

Since there is no training set mentioned, this information is not applicable / not provided.

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