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The Forsvall biopsy needle is intended to collect histological biopsy samples from soft tissue intended for clinical examination. The Forsvall biopsy needle is part of the Forsvall biopsy needle system for prostate biopsy and shall be used together with the Forsvall biopsy gun.

The Forsvall biopsy gun is intended to be used by medical professionals, together with the Forsvall biopsy needle, on male patients to obtain soft tissue samples. The Forsvall biopsy gun is part of the Forsvall biopsy needle system for prostate biopsy.

The Forsvall biopsy needle system for prostate biopsy is indicated whenever there is a need to obtain prostate biopsy samples.

The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel.

By pulling a handle on the Forsvall biopsy gun, the front wagon therein is tensioned and connected to the Forsvall biopsy needle. When tensioning the load pin also moves along a guide curve. When the front wagon is in its loaded position, the load pin has moved the front needle bracket a small distance backwards in the Forsvall biopsy gun.

The handle is pulled a second time to tension the rear wagon that is connected to the needle in the Forsvall biopsy needle. A tension is created between the outer tube and the needle in order to force closing of the Forsvall biopsy needle. The purpose is to prevent an interstice from arising in order to prevent accumulation of bacteria.

The Forsvall biopsy gun is fired by pushing the trigger, which causes the rear wagon to move forward of the front wagon. This results in the inner part of the needle being forced forward, followed by forward movement of the outer tube. When the Forsvall biopsy gun is fired, the load pin moves the outer tube the final millimeter in order to achieve a soft closing mechanism. On the Forsvall biopsy needle, the outer tube thus stops against the needle head and it is forced closed.

The Forsvall biopsy operates by the outer tube stopping against the needle head in the closing motion. Additionally, the final millimeter in the closing motion is a soft close action in order to protect the needle head from too strong forces. To enable the soft closing action, the Forsvall biopsy gun has a design similar to the predicate device.

This looks like a 510(k) summary for a medical device called the "Forsvall biopsy needle system for prostate biopsy." Unfortunately, the provided text does not contain the information necessary to answer your questions about acceptance criteria and the study proving the device meets them.

The document focuses on demonstrating substantial equivalence to a predicate device (Möller Medical Biopsy Needles and Systems) based on similar indications for use, technological characteristics, and general safety and performance.

Here's why I cannot provide the requested information from the given text:

• Acceptance Criteria and Device Performance Table: The document lists "Non-Clinical and/or Clinical Tests Summary & Conclusions," but it does not provide specific acceptance criteria (e.g., minimum sample length, specific force measurements) or a table comparing these criteria to the device's reported performance. It only states that "All non-clinical tests related to performance as described above passed."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document briefly mentions "User Testing" in a "simulated clinical setting" but provides no details about:
  • The sample size of this user testing.
  • The provenance of any data (e.g., country, retrospective/prospective).
  • The number or qualifications of experts.
  • Adjudication methods.
  • Whether it was an MRMC comparative effectiveness study or a standalone study.
  • The type of ground truth used.
  • Any training set information.

In summary, the provided FDA 510(k) summary (K242128) does not contain the detailed study information you are asking for regarding acceptance criteria and performance data. It's a regulatory document focused on establishing substantial equivalence, not a detailed scientific study report. Such detailed study information would typically be found in the full 510(k) submission, which is not publicly available in its entirety.

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