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The Möller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen.

Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow.

Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or iliac crest. Application areas of the products are bone respectively bone marrow.

Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow.

Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy guns.

Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various soft tissue lesions , and should be used with the Möller Medical Blue (RBG-1000-10-1000) biopsy gun.

Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidney.

Model COX is for safe needle guidance and for taking several biopsy specimens. for example from liver, kidney, breast. thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture.

Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.

Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.

Model Möller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.

When used for breast biopsy, the product is for diagnosis only. The extent of histological 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 histological 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 of using standard surgical procedures.

The Möller Medical Biopsy Needles and Systems consist of Bone and Bone Marrow Aspiration Needles, Fine Needles, Disposable Needles for Biopsy Guns, Coaxial Needles, Manual Cut Biopsy Needles, Semi-automatic and automatic Biopsy Guns.

The Möller Medical Blue RBG is a re-usable biopsy gun to be used with corresponding needles to obtain core samples from soft tissue. It is a re-usable device, which has to be reprocessed. The biopsy needles used with this device are disposable products. The Möller Medical Blue RBG is intended to be used with the DNG-1020 and the DNG-2020 needles.

Bone Marrow Biopsy System (BOW-1060), Bone Marrow Aspiration Biopsy (BOW-1070) and Bone Biopsy Needles (BOY-1080) are for harvesting bone and bone marrow specimens manually or by aspirating with a syringe.

Fine Needle Biopsy (FNB-xxxx) is used for percutaneous withdrawal of mainly cytological evidence of soft tissue using a syringe attached to a Luer-Lock adapter.

Disposable Needles for Biopsy Gun (DNG-1010, -1020, -1030, -1040) are used for obtaining core biopsies of various tissues in combination with different automatic biopsy guns and can be used with a corresponding coaxial needle for multiple sampling.

Full-sCore® Biopsy Needle (DNG-2020) is used for biopsies of soft tissue in combination with the Möller Medical Blue. It has a double-lumen cannula tube with a bevelled edge tip cut, a trokar stylet, and a lengthwise spade for cutting tissue. It can be used with a corresponding coaxial needle for multiple sampling.

Semi-automatic Biopsy Gun (SBG-xxx) is a disposable device to obtain histological core samples from soft tissue. It is composed of a spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. It can be used with a corresponding coaxial needle for multiple sampling.

Automatic Biopsy Gun (ABG-xxxx) is a disposable device to obtain core samples for histological evidence from soft tissue. It can be used with a corresponding coaxial needle for multiple sampling.

Coaxial Needles (COX-xxx) are guiding needles used with biopsy needles or systems to take several biopsy specimens from the same target area with only a single puncture. The guiding needle has a larger total diameter and is shorter in length than the corresponding biopsy needle or system.

Manual Cut Biopsy (MBY-xxxx) is a manual biopsy needle for obtaining histological tissue specimens using the tru-cut technique.

Based on the provided text, the document is a 510(k) Summary for Möller Medical Biopsy Needles and Systems. It explicitly states that the device is substantially equivalent to legally marketed predicate devices and does not present a study proving the device meets specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, or accuracy) in the context of an AI/human reader study.

The "Performance Data" section (Page 10, {10}) describes bench tests for the device's mechanical performance and material properties, but not its diagnostic efficacy or impact on human reading performance. The listed tests are: Intensity Test, Shelf Life, Artificial Ageing, Firing Test, Validation/Verification (another firing test), Functionality test (after 50 insertions), and Performance test (comparison of general function, penetration characteristics, tissue sample size, and mechanical durability with predicate devices).

Therefore, I cannot provide the requested information for an AI/human reader study or acceptance criteria related to diagnostic performance because the provided document does not contain this type of study or data.

Here's what can be inferred from the document regarding the type of "acceptance criteria" and "study" that was done:

• Acceptance Criteria (Implicit - based on 510(k) requirements): The primary acceptance criterion for this 510(k) submission is Substantial Equivalence to existing predicate devices. This means the device must have the same intended use, similar technological characteristics, and raise no new questions of safety or effectiveness. The various mechanical/physical bench tests passed according to "predetermined pass/fail criteria" (Page 10, {10}).
• Study That Proves the Device Meets Acceptance Criteria: The "study" here is a series of bench tests and a comparison to predicate devices to demonstrate similar performance and safety characteristics.

Regarding the specific points you asked for, here's how they relate to the provided text:

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

   • Acceptance Criteria (Mechanical/Physical): "all necessary and required tests for the BiopC Portfolio were appropriate performed and all tests passed according to the predetermined pass/fail criteria." (Page 10, {10}) The document does not specify the exact numeric pass/fail criteria for each test (e.g., minimum tensile strength, maximum firing force).
   • Reported Device Performance: The "Test" column in Table 2 lists the types of tests (e.g., Intensity Test, Shelf Life, Firing Test), and the "Tested Products" column indicates which models were tested. The "Test method summary" provides a general description of the test. The "✓" in the last column indicates that the test was performed. The text states: "all tests passed according to the predetermined pass/fail criteria." (Page 10, {10})
   • (Note: This is about device function, not diagnostic accuracy.)

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

   • Sample Size: Not specified for the bench tests (e.g., how many DNG needles were tested for shelf life).
   • Data Provenance: Not specified, but generally, 510(k) summary documents for device clearances do not detail data provenance for bench tests in the same way clinical studies do. These tests would typically be performed by the manufacturer (Möller Medical GmbH, based in Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in diagnostic accuracy (e.g., presence of disease confirmed by pathology) is not part of this type of device clearance based on bench testing. The "experts" would be engineers/technicians performing the physical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to mechanical bench testing.

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 device is a biopsy needle/system, not an imaging AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the "ground truth" would be objective measurements against engineering specifications and comparisons to predicate device performance (e.g., "Comparison of the general function, penetration characteristics, tissue sample size and mechanical durability of the different needles with the predicate devices" - Page 10, {10}).

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning model for this device clearance.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) clearance for medical biopsy needles and systems based on substantial equivalence to predicate devices and extensive mechanical/physical bench testing, not on clinical performance studies involving human readers or AI algorithms for diagnostic purposes.

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The LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.

The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristalticpump of LiguoGuard 7 whenever the current patient's CSF pressure is higher than a preselected target pressure. Thus the LiguoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient's mobility.

The provided text describes the acceptance criteria and the study that proves the device (LiquoGuard 7) meets these criteria. The study mainly involves bench testing.

Here's the information extracted and organized:

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

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The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

The LiquoGuard CSF System consists of a pump and a corresponding tube set with pressure sensors. The dynamic range of this system is from -15mmHg to +75 mmHg. The tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via Luer-Lock and the LiquoGuard CSF System device via cable connector. The device then continuously measures the pressure inside the tube and operates a tube pump whenever the actual pressure is higher than a preselected target pressure. Thus the LiquoGuard CSF System combines CSF drainage and intracranial pressure (ICP) monitoring with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient mobility (by its battery back-up).

Acceptance Criteria and Device Performance for LiquoGuard CSF System (K121248)

The provided document describes the Moller Medical LiquoGuard CSF System, which is indicated for external drainage and monitoring of cerebrospinal fluid (CSF). The acceptance criteria for this device are established through a combination of bench tests and a comparative clinical study against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the bench tests and the demonstration of equivalence in adverse event rates during the clinical study. No specific numerical thresholds for acceptance were explicitly stated beyond "all tests passed according to the predetermined pass/fail criteria."

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

• Sample Size (Clinical Study): 413 patient records.
• Data Provenance: The records were collected from "several hospitals," indicating a multi-center study. The clinical study combines "similar, independent studies," suggesting a retrospective collection and aggregation of existing patient data rather than a new prospective study exclusively for this submission. The country of origin of the data is not explicitly stated in the provided text.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The clinical study compares "adverse events" between the LiquoGuard and predicate devices, implying that these events were recorded as part of standard clinical practice.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study's adverse event data. It mentions identifying and comparing rates of incidence, which suggests a quantitative analysis of pre-recorded data rather than a consensus-based adjudication process for individual cases.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focused on comparing adverse event rates between the device and predicate devices in a clinical setting, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device is not an AI-driven diagnostic algorithm. It is a medical device that combines hardware (pump, sensors) and software for CSF drainage and monitoring. Therefore, a standalone (algorithm only) performance study as typically understood for AI/CAD devices was not performed. Its performance is assessed through the comprehensive bench tests and clinical comparison.

7. Type of Ground Truth Used for the Test Set

The ground truth for the "test set" (clinical study) was based on clinical outcomes data, specifically "adverse events" recorded in patient records resulting from CSF drainage using either the LiquoGuard or predicate drip chambers.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as would be typical for machine learning models. The device's development and validation relied on engineering principles, bench testing, and a clinical comparison to existing devices. Therefore, a specific sample size for a "training set" in the context of an AI/ML model is not applicable from the provided information.

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

As there is no explicit mention of a training set in the context of machine learning, the question of how its ground truth was established is not directly applicable. The device's functionality is based on established fluid dynamics, pressure sensing, and pump control mechanisms. Its design and performance would have been refined through iterative engineering development and testing against specifications derived from medical requirements and predicate device functions.

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