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The Ranfac Fat Aspiration Cannula is intended for use in aesthetic body contouring. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

The Ranfac Fat Aspiration Cannula consist of silicone coated stainless steel tubing that is closed on the distal end and has fenestrations in the side wall to allow fat to be aspirated into the tubing. There is a Luer Lock compatible handle made of ABS plastic, molded to the cannula.

The provided document is a 510(k) premarket notification for the Ranfac Fat Aspiration Cannula, which is a medical device and not an AI/ML powered device. As such, the information requested in the prompt regarding acceptance criteria and studies for AI/ML device performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the Ranfac Fat Aspiration Cannula to a predicate device, the Tulip Disposable Cannulas, based on similarities in:

• Intended use
• Design (sterile, disposable)
• Performance characteristics (e.g., attachment to Luer Lock syringe, available sizes and configurations)
• Cannula configuration (hollow, closed end, side ports)
• Gauge sizes (11Ga., 13Ga., 14Ga.)
• Lengths (10cm, 12cm, 15cm, 20cm, 25cm)
• Sterilization method (Ethylene Oxide)
• Materials (ABS plastic handle, ISO 9626 Stainless Steel cannula with silicone coating)

Performance Testing mentioned (Non-clinical Data):
The document states that performance testing was conducted to demonstrate substantial equivalence in aspiration performance. This involved:

• Aspiration of Distilled Water using both the Ranfac Fat Aspiration Cannula and various Tulip predicate cannulas (Trivisonno Micro Harvester, J.W. Little Harvester, GEMS Carraway Harvester) with 20cc and 30cc syringes.
• Aspiration of Silicone, Dow Corning 200 Fluid using the same comparison setup.
• Aspiration of Pure Glycerin using the same comparison setup.

However, the document DOES NOT provide specific acceptance criteria or quantitative results of these aspiration performance tests that would allow for the completion of the requested table. It only states that the testing was conducted to demonstrate substantial equivalence, implying the results were comparable, but no numerical data or thresholds are given.

Therefore, I cannot populate the table or answer the specific questions about AI/ML performance studies as the provided text pertains to a traditional medical device demonstrating substantial equivalence, not an AI/ML diagnostic or prognostic tool.

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The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.

This document is a 510(k) premarket notification for a medical device, specifically the Ranfac Aspirating Needle with Adjustable Guide. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a clinical study with acceptance criteria for device performance in a diagnostic accuracy context.

Therefore, many of the requested details about acceptance criteria for device performance, a specific study proving it, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of submission. This document highlights the device's physical and material characteristics, its intended use, and its adherence to relevant manufacturing and sterilization standards.

Here's the breakdown of what can be extracted and what is not available based on the provided text:

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

Not provided in this document. This submission focuses on demonstrating substantial equivalence through comparison of materials, design, technological characteristics, and adherence to standards, not on clinical performance metrics like sensitivity or specificity.

2. Sample size used for the test set and the data provenance

Not applicable. No diagnostic accuracy test set is described. The "test" here refers to non-clinical testing against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth for diagnostic accuracy is established as this is not a diagnostic device with performance claims.

4. Adjudication method for the test set

Not applicable.

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, nor is it a diagnostic imaging device typically associated with MRMC studies.

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

Not applicable. This is a physical medical device (an aspiration needle), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "truth" in this context relates to meeting engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Information that can be extracted related to the device and its "acceptance":

While there isn't a table of clinical acceptance criteria and performance as you'd find for a diagnostic algorithm, the document does describe criteria for the device's design, materials, and manufacturing, and states that these criteria are met. This is implicitly the "acceptance criteria" for this type of device and submission.

"Acceptance Criteria" and "Study Proving Acceptance" (as interpreted from the document for a physical device):

Study that proves the device meets the acceptance criteria:

The document states that the "Non-clinical Data: Standards" section indicates compliance. The "study" isn't a single traditional clinical trial but rather the demonstration of adherence to specified international and national standards relevant to medical device manufacturing, materials, and sterilization. This involves testing and validation performed by the manufacturer to ensure the device meets the requirements of these standards. The conclusion explicitly states: "Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Aspiration Needle with Adjustable Guide, subject of this premarket notification and the predicate devices, the Ranfac Aspiration Needle with Adjustable Guide has been shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." This "showing" is the proof for this type of submission.

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The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow.

The Ranfac Bone Marrow Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.

The provided text describes a 510(k) summary for the Ranfac Bone Marrow Aspiration Needle, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness or meeting specific performance criteria through a new clinical study. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, and ground truth establishment is not part of this 510(k) submission.

The document explicitly states: "Clinical Data: Not applicable" (page 3). This means no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria. Instead, the submission relies on non-clinical data and comparison to predicate devices.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:

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

Since no clinical study was conducted for this 510(k) submission, there are no specific performance-based acceptance criteria or reported device performance metrics in the traditional sense of a clinical trial. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety.

The summary focuses on conformance to recognized standards for materials, luer lock connections, and sterilization.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical test set data is provided in this 510(k) summary (as explicitly stated by "Clinical Data: Not applicable").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set and thus no ground truth established by experts is mentioned in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No clinical test set is mentioned in this 510(k) summary.

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 bone marrow aspiration needle, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. This device is a bone marrow aspiration needle, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As "Clinical Data: Not applicable" is stated, no ground truth from a clinical study is provided. The basis for clearance is substantial equivalence to predicate devices, supported by non-clinical conformance to standards and material/design comparisons.

8. The sample size for the training set

Not applicable. This device is not an AI-driven system requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI-driven system requiring a training set or associated ground truth.

In summary: The provided 510(k) summary for the Ranfac Bone Marrow Aspiration Needle demonstrates substantial equivalence to predicate devices primarily through comparison of materials, design, principles of function, biocompatibility, and sterilization methods, along with conformance to relevant industry standards for medical device components and manufacturing processes. It explicitly states that clinical data is "Not applicable" for this submission.

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The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.

The subject device is a sterile disposable product featuring a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL that captures tissue. The device functions by pulling back the pull ring until the trigger cocks and pressing the trigger until the device fires. The biopsy is captured by the snare located inside the outer needle cannula.

The provided text indicates that the device, the Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle, did not undergo a clinical study. Instead, its acceptance was based on non-clinical performance verification testing and a demonstration of substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The document explicitly states "Clinical Data: Not Applicable." The performance verification was non-clinical.
• Data Provenance: Not applicable, as no clinical data was used. The non-clinical data would have been generated internally by Ranfac Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No experts were mentioned for establishing ground truth as there was no clinical test set. The functional acceptability for the non-clinical testing would have been evaluated against internal company specifications and standards.

4. Adjudication method for the test set

• Not applicable. There was no clinical test set or human interpretation involved to require an adjudication method.

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

• No. The document explicitly states "Clinical Data: Not Applicable," and there is no mention of AI assistance or human readers.

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

• Not applicable. The device is a physical biopsy needle, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance verification, the "ground truth" would have been established by the device's functional specifications and engineering requirements (e.g., successful tissue capture, firing mechanism functionality, material integrity). This isn't external pathology or outcomes data but internal test results against predefined criteria.

8. The sample size for the training set

• Not applicable. The device is a physical medical instrument, not an AI or algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there was no training set for an AI or algorithm.

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The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.

Ranfac Single Action Biopsy Needle

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for a medical device.

The document is a 510(k) clearance letter from the FDA for a "Ranfac Single Action Biopsy Needle." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

It primarily focuses on:

• Device Name: Ranfac Single Action Biopsy Needle
• Regulation Number: 876.1075
• Regulatory Class: II
• Product Code: KNW, FCG
• Date: August 22, 2001
• Indications For Use: Obtaining a percutaneous soft tissue biopsy.
• Regulatory process: Confirmation of substantial equivalence based on the 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions based on this input.

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Ask a specific question about this device