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HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver.

The device is for prescription use, to be used by physicians in hospitals and clinics.

Both the HS NOTA and the predicate device consist of a 304 stainless steel cannula and stylet. In both the devices the cannula and stylet inner handles are moved by springs that must be loaded, toward a charging lever positioned on the external housing of the needle, before firing the needle.

Both PRECISA and HS NOTA are single patient use, disposable, sterile and non-pyroqenic products.

The external plastic handle of HS NOTA has a different shape relative to the predicate device. This difference does not affect the performance or safety of the device as it does not affect the advancement and penetration of the needle inside the tissues, yet it just implies a different way for the user to handle the device.

The charging lever for PRECISA needle is straight, it means operator must pull-it for charging, while the NOTA one is designed to be rotated for loading the springs. This difference is a consequence of the specific external plastic handles of HS NOTA relative to the predicate device and does not impact in safety and effectiveness of the needles.

HS NOTA needle performs a biopsy of 2.5 cm of length inside the soft tissue. PRECISA needle can be adjusted to advance 1 cm or 2 cm of length. When considering PRECISA needle in 2 cm advancing configuration there is a total equivalence between the two devices. Indeed the additional run of 0.5 cm characterizing HS NOTA, is only due to the different inner mechanism of the HS NOTA compared to PRECISA and it does not affect safety and effectiveness: final outcomes in terms of quality and length of the bioptic samples depend on the notch realized on the stylet (shape of stylet tip) which is exactly the same for both HS NOTA and PRECISA.

The sample notch size is 20 mm. So maximum length for core collected is 20 mm.

The shape of cannula and stylet tips are exactly the same for HS NOTA and PRECISA. It means that the HS NOTA and PRECISA are substantially equivalent as capacity to cut the soft tissue.

The Spring used inside the two devices are exactly the same, it means that the force moving the cannula and stylet of both the needle is exactly the same.

Needles diameter characterizing both HS NOTA and PRECISA are 14G, 16G, 18G, and 20G. Furthermore both the devices are provided with needles characterizing by a length within the range 7 cm-25 cm.

HS NOTA is provided with a safety element that is automatically activated as the spring has been loaded. The safety feature must be removed by the physician to fire the device. This mechanism allows to avoid accidental firing of the needle. The predicate device has been manufactured with an identical safety element.

Inner mechanism: The inner mechanism for an automatic biopsy device is responsible for the automatic movements of both stylet and cannula composing the needle. The inner mechanism of HS NOTA is composed by:

1. 2 plastic handles, each plastic handle is attached to stylet and cannula distal part, both these handles slide inside the external plastic housing of the product, each plastic handle is provided with hooking means capable to retain the handle in charged position once the spring has been charged
2. Inner spring that must charged, they are responsible for the automatic advancing of the inner plastic handles.
3. A firing lever which is capable to pull back the inner plastic handles (loading the sprinq) during the charging phase and which is capable to act on the hooking means (which are part of the inner plastic handles) realising them and making possible the inner handles advancing.

PRECISA inner mechanism is composed by the same functional elements.

During the functioning of the product no mechanical damages on these parts must occur.

Materials:

The only part of HS NOTA coming in contact with the patient is represented by the cannula and stylet that are made of biocompatible AISI 304 material, identically to the predicate device. The external part of the device representing the plastic handle is made of nylon while PRECISA's plastic handle is made of ABS. This difference does not affect effectiveness and safety of the device since both nylon and ABS have equivalent characteristics: they are thermoplastic materials allowing the needle to move properly and providing adequate resistance to the force exerted by the spring on the device.

The provided document is a 510(k) summary for the medical device HS NOTA, an automatic biopsy needle. The summary focuses on establishing substantial equivalence to a predicate device (HS Hospital Service S.p.A. "PRECISA" biopsy needle, K002944) and does not contain detailed acceptance criteria and a study proving those criteria are met in the way typically found in performance studies for AI/ML devices.

However, based on the closest information available, here's an attempt to answer the request, highlighting what is implicitly or explicitly stated.

Interpretation: The "acceptance criteria" here are functional performance requirements for a biopsy needle, primarily related to its ability to fire, penetrate tissue, and obtain adequate biopsy samples without mechanical failure. The "study" refers to the performance tests conducted on the HS NOTA device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions that the device was able to obtain the claimed 20 samples. This likely refers to the number of firings or samples taken per device tested, rather than the number of devices or tissue blocks. The exact number of devices or tissue blocks tested is not specified, but the tests involved "different samples" of bovine liver, bovine scrotum, pork lard, and bovine fat.
• Data Provenance: The document does not explicitly state the country of origin for the data or tissue samples used. The study was conducted as a performance test to support a 510(k) submission, implying it's a prospective internal test conducted by the manufacturer (H.S. Hospital Service S.p.A., Italy).

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

This type of study (performance testing for a biopsy needle's mechanical and sample retrieval capabilities) does not typically involve human experts establishing a "ground truth" in the way an AI/ML diagnostic device study would. The "ground truth" here is the physical performance of the device (e.g., successful firing, no damage, measured core length, visual inspection of sample quality). There is no mention of experts, such as radiologists or pathologists, being involved in establishing ground truth for these specific performance tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is a physical performance test, not a subjective assessment requiring expert adjudication. The "ground truth" is measured or observed directly by the testing personnel.

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 is not an AI-assisted device. The document describes a physical medical device (an automatic biopsy needle) and its mechanical and functional performance, not a diagnostic algorithm.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on direct physical measurement and observation of device functionality and retrieved samples. This includes:

• Observation of "good needle advancement and penetration."
• Confirmation of no "damage to the interior mechanism" after multiple firings.
• Measurement of "core length" of biopsy samples (expected 20mm maximum).
• Assessment of "quality" and "size" of biopsy samples.
• Verification of safety mechanism activation.
• Biocompatibility of materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.

This device is an automated, disposable biopsy needle

This document is a 510(k) summary for the BIOSPEED™ Spring Loaded Biopsy Needle. It outlines the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding clinical studies, acceptance criteria, or device performance data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This document does not present any performance data or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study would not typically be applicable to a basic biopsy needle like this, which is a physical instrument rather than an AI-enabled diagnostic tool.
6. If a standalone study was done: Not mentioned. Again, for a physical instrument, "standalone" performance (without human interaction) isn't a relevant concept in the same way it would be for an AI algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion: The provided document is a regulatory submission summary primarily focused on establishing substantial equivalence for a medical device. It does not contain the detailed clinical study design, performance data, or ground truth establishment information required to answer your specific questions about acceptance criteria and device performance studies. Such information would typically be found in a separate, more comprehensive testing report or clinical study report, which is not part of this 510(k) summary.

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This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

Not Found

The provided document is a 510(k) summary for a medical device called the "Jamshidi Bone Marrow Biopsy Needle." It pertains to the regulatory clearance of a device, not a study evaluating its performance against specific acceptance criteria. This type of document is about demonstrating substantial equivalence to a predicate device for market approval, rather than reporting on a clinical or technical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it does not contain details about a performance study with such metrics.

The document primarily provides:

• Applicant Information: H.S. Hospital Service S.p.A.
• Contact Person: Mr. Lucio Improta
• Device Name: Jamshidi Bone Marrow Biopsy Needle
• Intended Use: For drawing osteomedullary substance and/or for explantation of bone marrow.
• Regulatory Information: Classification, product codes, and the FDA's clearance letter.

The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already legally marketed. This process often involves showing that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does not typically require the detailed performance study data against pre-defined acceptance criteria as would be found in a clinical trial report or a scientific publication.

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This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease

SecurcutTM Aspiration Biopsy Needle

The provided text describes a 510(k) premarket notification for the "Securcut™ Aspiration Biopsy Needle." This document is not a study report and therefore does not contain the information required to answer the questions about acceptance criteria and device performance evaluation.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a regulatory submission for premarket clearance, primarily focused on establishing substantial equivalence to a predicate device. It briefly mentions the intended use but does not outline specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present any study results demonstrating the device meets such criteria.
• No Study Details: There is no description of any clinical or performance study, nor details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set specifics.

Therefore, I cannot provide the requested information based on the given input.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the 510(k) process relied on demonstrating equivalence to an existing device, rather than presenting a performance study with acceptance criteria.

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