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The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.

The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary for the BioPince™ Ultra Full Core Biopsy Instrument, primarily focused on establishing substantial equivalence to predicate devices and outlining the device's intended use and technological characteristics.

However, based on the Performance Tests section, we can infer the overarching acceptance criteria and the nature of the study.

Inferred Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This implies that the acceptance criteria for the BioPince™ Ultra were to demonstrate equivalency in performance to its predicate devices concerning their functional aspects. While specific quantitative metrics are not provided, these would typically include aspects relevant to biopsy instruments, such as:

• Ability to obtain a full-core specimen: The device's primary function.
• Specimen expulsion mechanism: Ensuring the sample is released upon re-cocking.
• Reliability of firing mechanism: Consistent operation of the trigger buttons.
• Safety features: Proper functioning of the safety button.
• Material compatibility/biocompatibility: Though not explicitly a "performance test" in the functional sense, it's a key aspect for medical devices.
• Sterility: As a disposable device.

Inferred Study to Prove Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This indicates that a comparative performance study was conducted.

Here's an attempt to populate the requested table and sections based on the available information and common practices for 510(k) submissions of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative metrics or detailed results for these performance aspects. The "reported device performance" is a high-level statement of equivalency.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. It's likely an in-house or contracted laboratory study, common for medical device performance testing, rather than patient data. Given the regulatory submission is from Canada (Angiotech contact) to the US FDA, the provenance could be international, but this is not stated. It is a prospective study if referring to the controlled performance tests conducted specifically for this submission.

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

• This type of performance testing for a biopsy instrument typically does not involve human experts establishing a "ground truth" in the sense of clinical diagnosis or interpretation of images. The ground truth would be objectively measured physical characteristics of the biopsy samples (e.g., core length, tissue integrity) or functional aspects of the device (e.g., successful firing, effective specimen expulsion).
• The "experts" involved would likely be engineers, quality assurance personnel, and potentially histologists or pathologists to evaluate the quality of the tissue samples obtained, but this is not explicitly stated. Their qualifications would be relevant to their specific roles (e.g., biomedical engineers, certified histotechnologists).

4. Adjudication Method for the Test Set

• Since this is performance testing of a physical device against technical specifications and predicate device performance, an adjudication method like "2+1" or "3+1" (which are typically used for disagreements in human expert assessments, e.g., in radiology studies) is not applicable.
• Results would be determined by objective measurements, pass/fail criteria, and comparison to predicate device data or established benchmarks. Any discrepancies during testing would be investigated and resolved through standard engineering and quality control procedures.

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

• No, an MRMC comparative effectiveness study was not done.
  • MRMC studies are typically used to assess the diagnostic performance of a technology (often AI-based imaging tools) by comparing how human readers perform with and without the technology's assistance across multiple clinical cases.
  • The BioPince™ Ultra is a physical biopsy instrument, and its performance is evaluated based on its mechanical function and ability to obtain tissue, not on its interpretation of images or clinical data.

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

• Not applicable.
  • This question pertains to algorithms or AI models. The BioPince™ Ultra is a mechanical device.
  • The performance assessment focused on the device itself (its mechanical and functional attributes) rather than an algorithm.

7. The Type of Ground Truth Used

• The ground truth for this device's performance testing would be objective physical measurements and functional verification. Examples include:
  • Histological confirmation: Examination of tissue cores obtained to ensure they are full-core, intact, and suitable for histological analysis. This might involve pathology review, but not as "experts establishing ground truth" in a diagnostic sense for the device's performance, but rather confirming the quality of the output.
  • Engineering specifications: Ensuring firing force, needle throw length, specimen retention/expulsion, and safety features meet design requirements.
  • Comparison to predicate device performance: Directly matching or exceeding the performance characteristics of the legally marketed devices mentioned (BioPince™ Full Core, Tru. Core™, V-Core™, Easy Core™).
  • It does not involve outcomes data in the clinical sense for this type of submission.

8. The Sample Size for the Training Set

• Not applicable / Not specified.
  • "Training set" refers to data used to develop and train algorithms (e.g., in machine learning). The BioPince™ Ultra is a mechanical device, not an algorithm.
  • Any "training" in the context of this device would refer to design iterations, prototype testing, and manufacturing process validation, not a data training set for an AI.

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

• Not applicable.
  • As explained above, there is no "training set" in the context of an algorithm for this device. Design and testing iterations (if any) would use engineering principles and physical measurement for validation.

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