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The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.

The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.

The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.

This document is a 510(k) summary for a Bone Marrow Biopsy Needle. It includes a comparison to a predicate device and non-clinical testing. However, it does not include acceptance criteria for device performance, nor does it describe a study proving the device meets specified criteria. The document explicitly states "No clinical data was provided."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information provided only demonstrates that bench tests (puncture test, torque test, stiffness test, toughness test, and corrosion resistance test) were conducted and "all test results meet the performance requirements." Furthermore, an "ex vivo sample quality comparison" was performed, and "all the result shows the subject are substantially equivalent to the predicate devices." No specific criteria or detailed results for these tests are presented.

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The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

The Ranfac Bone Marrow Biopsy Needles subject of this premarket notification (RTN-114, RTN-116, RTN-84, RTN-86, RTN-114-T, RTN 116-T, RTN-84-T, RTN-86-T, RJN -114, RJN -116, RJN-84, RJN-86) are manual, sterile disposable needles intended for the purpose of harvesting bone marrow specimens. The device is comprised of an outer cannula with handle and an inner stylet. The cannula has graduated etched markings spaced in 1 cm intervals. The product is provided with a probe guide and marked probe to assist with the extraction of the bone marrow specimen from the needle. The probe guide facilitates the insertion of the marked probe through the distal end of the needle. The marked probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. Specific models of the Ranfac Bone Marrow Biopsy Needles are also provided with a stainless steel marrow extraction cannula (either Canoe or Tweezer design) which fit inside the needle to facilitate capture and retrieval of bone marrow samples. The specimen is contained within the extraction cannula during withdrawal from the needle. The Ranfac Bone Marrow Biopsy Needles are provided with a luer cap to prevent back flow of blood during needle insertion and product with the optional extraction cannula are provided with two needle vices to cap the needle and stylet tip prior to disposal.

I am unable to provide the details you requested regarding acceptance criteria and study data for the device. The provided text is an FDA 510(k) clearance letter for Ranfac Bone Marrow Biopsy Needles, not a study report or clinical trial summary.

While the document states that "Performance testing and comparison of characteristics between the subject and predicate devices have demonstrated that the Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices...", it does not include specific acceptance criteria, detailed performance data, sample sizes, information on ground truth establishment, or any of the other specific study parameters you requested.

The document only generally mentions:

• Biocompatibility Testing: Passing results for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, and Material-Mediated Pyrogenicity.
• Bench Testing:
  • Structural integrity testing (tensile/torque) with all samples meeting or exceeding acceptance criteria.
  • Comparative performance testing using the Jamshidi Bone Marrow Biopsy/Aspiration Needle demonstrating suitability for bone marrow sampling.
  • Simulated use testing to validate design output met design input requirements.
• Clinical Studies: "No clinical studies were conducted for this submission."

Therefore, I cannot extract the information required to populate the fields in your request, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, or details on ground truth for training or test sets.

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The medical devices object of this 510K are all needles for biopsy. The products could be classified in 3 families that are:

• the needles for bone-marrow biopsy (In this family of needles for bone-marrow biopsy there is also a little group of devices intended for bone-marrow explants). In particular the indications for use for each different model are the followings:

OSTEOBELL 'T': Needle for bone-marrow biopsy
ORION: Needle for bone-marrow biopsy
ILIAC-MARROW: Needle for bone-marrow biopsy
OBSTERN: Needle for bone-marrow biopsy
STERNOBELL: Needle for bone-marrow biopsy
TOTALLY REMOVE: Needle for bone-marrow biopsy
UNLUX SYSTEM: Needle for bone-marrow biopsy
OSTEOBELL EXPLANT: Needle for bone-marrow explant
ORION EXPLANT: Needle for bone-marrow explant
ILIAC-MARROW EXPLANT: Needle for bone-marrow explant
OBSTERN EXPLANT: Needle for bone-marrow explant
STERNOBELL EXPLANT: Needle for bone-marrow explants

• the semiautomatic quillotine needles for soft-tissue biopsy (breast, kidney, liver, prostate):
  SPEEDYBELL: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
  SPEEDYBELL DOPPIA CORSA: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

SPEEDYBELL & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

• the automatic guillotine needles for soft-tissues biopsy (liver):
  ESTER: automatic quillotine needle for soft-tissue biopsy (liver)
  ESTER & INTRODUTTORE: automatic guillotine needle for soft-tissue biopsy (liver)

The medical devices object of this 510K are all needles for biopsy, used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination (biopsy). The devices could be classified in 3 families that are:

• the needles for bone-marrow biopsy,
• the semiautomatic guillotine needles for soft-tissue biopsy and
• the automatic quillotine needles for soft-tissue biopsy.

All the needles are single use and sterile (ETO sterilization).

All the needles are composed with an external cannula (tube) and an internal stylet (mandrel) both in AISI 304 stainless steel. The grip of the needles is in plastic (different depending from the model).

The provided document describes the acceptance criteria and the studies conducted to demonstrate the safety and effectiveness of Biopsybell S.R.L.'s biopsy needles. The studies are non-clinical bench tests performed on three families of biopsy needles: needles for bone-marrow biopsy, semiautomatic guillotine needles for soft-tissue biopsy, and automatic guillotine needles for soft-tissue biopsy.

Here's an organized summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Family 1: Needles for Bone-Marrow Biopsy (Test Report n°59/10 dated 08/11/2010)

Family 2: Semiautomatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°67 dated 08/11/2010)

Family 3: Automatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°68 dated 30/04/2012)

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

The studies are non-clinical bench tests. The document does not specify exact numerical sample sizes for each test in terms of "n=". Instead, it states that:

• Family 1 (Bone-Marrow): "2 model of products that are the worst case of all the other models" (ILIAC MARROW and TOTALLY REMOVE) were used. The "sterile devices have been utilized for each code in the test samples." The tests included "repeatedly tested" for handle grip and "three different trials" for Luer-lock.
• Family 2 (Semiautomatic Soft-Tissue): "Five samples" of 'Speedybell doppia corsa' (worst case model) were used, manufactured in "four different lots, having 14G, 16G and 18G diameters and lengths ranging from 70mm, 100 mm." Tests were conducted both at 1cm and 2cm shots.
• Family 3 (Automatic Soft-Tissue): 'Ester' devices of different diameters and lengths (16G and 18G diameters, 100 mm and 150 mm lengths) from "different lots" were used.

Data Provenance:
The data provenance is retrospective, as these were bench tests performed by the manufacturer (Biopsybell S.R.L.) as part of their 510(k) submission. The tests involved the use of animal tissues (calf femur, liver, muscle), and artificial tissues (expanded polyurethane, apples). The country of origin for the studies is implied to be Italy, where Biopsybell S.R.L. is located.

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

The ground truth in these bench tests was established through direct observation and measurement of the physical properties and performance of the devices by the testing personnel. The document does not specify the "number of experts" or their "qualifications" in the sense of clinical experts (like radiologists). The "ground truth" was based on objective physical testing, visual inspection, and measurement by technical personnel responsible for conducting the bench tests. For example, "visually tested" and "carefully reviewed and measured."

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1, 3+1 consensus) is described, as the "ground truth" for these bench tests was based on direct physical observations, measurements, and functional assessments performed by the testing team. The results were reported directly from these tests.

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

No MRMC comparative effectiveness study was done. The studies are non-clinical bench tests evaluating the physical and functional performance of the biopsy needles, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (biopsy needles), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used was based on objective physical measurements, functional assessments, and visual inspection of the device's performance in different tissue types (animal and artificial). This included:

• Ease of penetration (visual/manual assessment)
• Integrity and quantity of collected samples (measurement, video-microscope examination)
• Mechanical function (Luer-lock compliance, shot completion, handle integrity)

8. Sample Size for the Training Set

Not applicable. These are non-clinical bench tests of a physical device, not an AI model, so there is no "training set."

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

Not applicable, as there is no training set for an AI model.

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The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.

The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.

The provided text is a 510(k) summary for the SnareLok Bone Marrow Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use. The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input.

Here's a breakdown of why the information is missing and an explanation of the type of information typically found in such studies:

• Acceptance Criteria and Device Performance: The document describes the device and its intended use but does not present any quantitative performance metrics (e.g., successful biopsy retrieval rates, tissue integrity scores, time to complete procedure) or associated acceptance criteria.
• Sample Size and Data Provenance: Without a study being mentioned, there's no information on sample sizes, country of origin, or whether it was retrospective or prospective.
• Experts and Ground Truth: There's no mention of experts or the establishment of ground truth as no performance study is described.
• Adjudication Method: Not applicable as no study is mentioned.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study is more common for imaging-based diagnostic AI devices where human reader performance is compared with and without AI assistance. The SnareLok is a mechanical biopsy needle.
• Standalone Performance: Not applicable as no performance study is mentioned.
• Type of Ground Truth: Not applicable.
• Training Set Sample Size and Ground Truth Establishment: Not applicable as this device is a physical instrument, not an AI/software device that would require training data.

General Explanation of What Would Be Included in a Performance Study for a Biopsy Needle (if it were present):

If a performance study for a biopsy needle were included, it would typically involve:

1. Acceptance Criteria: Predetermined thresholds for various performance metrics, such as:
   • Specimen Adequacy Rate: The percentage of retrieved samples that are deemed sufficient for diagnosis by a pathologist. (e.g., >= 95%)
   • Specimen Length/Integrity: Average length of retrieved core samples and subjective grading of fragmentation. (e.g., average length >= X mm, = 98%)
   • Ease of Use/Handling: Often assessed qualitatively through surgeon feedback.
   • Complication Rates: Incidence of adverse events (e.g., hemorrhage, infection, pain). (e.g.,

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For procuring bone marrow core biopsies from patients with hematologic abnounalities

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Medsol Goldenberg Bone Marrow Biopsy Needle." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing detailed study results or acceptance criteria for a new device's performance.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for an AI/CAD system), cannot be extracted from this document.

This letter confirms that the device is substantially equivalent to a pre-amendments device and can be marketed subject to general controls. It does not contain data from performance studies in the way modern AI device submissions do.

In summary, based on the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document is a clearance letter, not a performance study report.
2. Sample size for test set and data provenance: Not applicable. Performance study details are not provided.
3. Number and qualifications of experts for ground truth: Not applicable. Performance study details are not provided.
4. Adjudication method for test set: Not applicable. Performance study details are not provided.
5. MRMC comparative effectiveness study and effect size: Not applicable. This device is a biopsy needle, not an AI/CAD system for which MRMC studies are typically conducted.
6. Standalone performance study: Not applicable. Performance study details are not provided.
7. Type of ground truth used: Not applicable. Performance study details are not provided.
8. Sample size for training set: Not applicable. This device is a physical medical instrument, not an AI model that requires a training set.
9. How ground truth for training set was established: Not applicable. This device is a physical medical instrument, not an AI model.

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The intended use of the Worldwide Medical Technologies Bone Marrow Biopsy Needle is to obtain a sample of bone marrow for histological examination in the diagnosis and treatment of various diseases. The sample is typically taken by percutaneous puncture of the posterior iliac creast of the pelvis.

Worldwide Medical Technologies Bone Marrow Biopsy Needle

The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. This is a 510(k) clearance letter for a medical device (Bone Marrow Biopsy Needle), which primarily focuses on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.

A manually operated biopsy needle used for aspiration or explantation of bony substance.

The provided document describes a medical device, the BIOMID® - Bone Marrow Biopsy Needle, and its safety and effectiveness based on a submission made in April 1996. The document details the physical characteristics and intended use of the device, comparing it to a predicate device (Promedical - Jamshidi style biopsy needle).

However, the provided text does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), or any study details that would typically be associated with evaluating an AI/ML-based medical device.

The "tests" mentioned are standard biocompatibility and safety tests for a physical medical instrument:

• Intracutaneous Reactivity: Passed
• Acute Systemic Toxicity: Passed
• Pyrogen Test: Passed
• Cytotoxicity: Passed

These tests demonstrate that the materials used in the BIOMID® needle are safe for contact with human tissue and do not cause adverse reactions. They do not involve "device performance" in the sense of diagnostic accuracy or a comparison against a clinical ground truth, which is what your request implies.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (e.g., sensitivity, specificity) are mentioned beyond the "Passed" status of the biocompatibility tests.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable; this is a physical biopsy needle, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document describes a traditional medical device submission focused on material safety and equivalence to a predicate device, not an AI/ML-driven diagnostic or assistive technology.

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