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The Lateral Access Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac Lateral Access BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle. During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow). An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed. The device is also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.

The provided document is a 510(k) Premarket Notification for the Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA). It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic performance study. The document focuses on demonstrating substantial equivalence to a predicate device primarily through comparison of design, materials, and functional characteristics for a physical medical device (a needle), and basic performance testing for structural integrity and sterility.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and study data for an AI/ML device, as it is not present in the provided text.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "All samples met or exceeded acceptance criteria" for structural integrity testing, but does not detail these criteria or performance metrics. This is for the physical device's robustness, not diagnostic performance.
• 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML device's test set. For the physical device, it mentions "All samples" for structural integrity testing, without specifying the number of samples or data provenance (e.g., country of origin, retrospective/prospective).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (a needle), not an AI/ML algorithm or diagnostic tool where ground truth would be established by experts.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section states: "Structural integrity testing was conducted on the Ranfac LA BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications (resistance to breakage and torque) are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use testing was performed to validate that the design output of the Ranfac LA BMA Needle met design input requirements." This refers to mechanical and design performance, not diagnostic accuracy or AI/ML performance.

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The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.

The provided text describes the 510(k) submission for the Ranfac FLEX BMA Needle, asserting its substantial equivalence to a predicate device. However, this submission does not contain information about a study that assesses AI/algorithm performance or human reader performance with AI assistance.

Therefore, I cannot fill in the table or provide details for most of the requested points related to AI/algorithm performance, multi-reader multi-case studies, or the specifics of training and test sets and their ground truth.

The document focuses on demonstrating the device's physical and functional equivalence through engineering and biological testing, not through clinical performance data relevant to AI model validation.

Here's a breakdown of what can be extracted from the document based on your request, and where information is missing:

Acceptance Criteria and Device Performance (as far as applicable to this document)

Detailed Study Information (Based on Document Content)

This document describes the 510(k) submission for a physical medical device (a bone marrow aspiration needle), not an AI-powered diagnostic or assistive tool. Therefore, most of the requested information, which pertains to AI/algorithm development and validation, is not present in the provided text.

1. Sample size used for the test set and data provenance:

   • Not applicable for AI/algorithm testing. The document mentions "Structural integrity testing," "simulated use and cadaver testing," "biocompatibility testing," "sterility validation," and "shelf life studies." Specific sample sizes for these engineering and biological tests are not detailed beyond "All samples" for structural integrity.

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

   • Not applicable for AI/algorithm testing. Ground truth, in the context of an AI model, typically refers to expert labels on a dataset. This concept does not apply to the validation of a physical medical device as described here.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for AI/algorithm testing. Adjudication is a process to resolve disagreements among human labelers, which is not relevant to the physical device validation described.

4. 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. Not applicable. This document pertains to clearances for a physical device, not an AI system that assists human readers.

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

   • Not applicable. This device is a manual, physical instrument. There is no algorithm to test in standalone mode.

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

   • Not applicable for AI/algorithm testing. For the physical device, "ground truth" would be the success of a mechanical test, sterility validation result, or biocompatibility outcome. These are defined by established standards (e.g., ISO 11135 for sterility).

7. The sample size for the training set:

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

8. How the ground truth for the training set was established:

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

Summary: The provided FDA 510(k) submission describes the substantial equivalence of a physical medical device (bone marrow aspiration needle) to a predicate device. The performance data shared relates to the manufacturing, material, and mechanical properties of the needle, and does not involve AI algorithms or human reader performance studies. Therefore, most of the requested details concerning acceptance criteria and studies for AI-based devices cannot be extracted from this document.

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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 Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.

The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The 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. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively).

The provided document is a 510(k) Summary for the Ranfac Cartilage Biopsy Needle. It includes some performance data (bench testing) but does not describe acceptance criteria, a specific study proving it meets those criteria, or details regarding sample sizes for training/test sets, expert ground truth establishment, or MRMC studies. The document indicates "No clinical studies were conducted for this submission."

Here's an analysis of the available information based on your request:

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

The document does not explicitly present a table of acceptance criteria or detailed performance metrics. It provides qualitative statements about bench testing results:

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

The document does not specify a sample size for the bench testing beyond "All samples." It states that articular cartilage was harvested from "ex vivo bovine knees." This indicates the data provenance is ex-vivo animal tissue (bovine), and the nature of the test is prospective in the sense that the testing was conducted for this submission.

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

The document mentions "histological analysis" for evaluating sample integrity but does not specify the number or qualifications of experts involved in this analysis for the bench testing.

4. Adjudication method for the test set

The document does not describe any adjudication method for the bench testing results.

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, an MRMC comparative effectiveness study was not done. The device described is a physical biopsy needle, not an AI-powered diagnostic tool. The document explicitly states: "No clinical studies were conducted for this submission."

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

Not applicable. This device is a physical biopsy needle. There is no algorithm or AI component.

7. The type of ground truth used

For the bench testing, the ground truth for "sample integrity" was established via histological analysis of the cartilage samples acquired.

8. The sample size for the training set

Not applicable. The device is a physical biopsy needle, not a machine learning model. There is no training set mentioned or implied.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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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 FATS Procedure Pack is used in medical procedures involving the harvesting of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & reconstructive surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, arthroscopic surgery.

The Ranfac Fat Aspirate Transfer System (FATS) is designed to allow for sterile processing and transfer of the collected adipose tissue. The device consists of a procedure pack including the following components: two sterile centrifugation syringes, two each 30 mL and 20 mL sterile syringes for adipose tissue aspirate transfer, and other luer fittings as accessories to be used to transfer into and from the centrifugation syringe. Additionally, a non-sterile, reusable centrifugation syringe Containment Vessel is provided as a separate accessory which allows the centrifugation syringe to fit within a commercially available centrifuge.

This document describes a 510(k) premarket notification for the Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format for performance metrics like fat viability, purity, or recovery rate. Instead, it mentions that "Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Ranfac FATS Procedure Pack is adequately designed for the intended use indicated."

The "Performance Data" section lists the types of tests conducted:

• Fluid transfer into and from the process disposable: This would likely involve ensuring efficient and sterile movement of fluids within the system.
• Centrifugation tests: This would assess the device's ability to withstand centrifugation and effectively separate components.
• Data to support conformance with applicable requirements of ISO 7886-1:1993: This standard relates to sterile hypodermic syringes for single use. Conformance would imply meeting specified dimensional, functional, and material requirements for syringes.
• Simulated use: This testing would mimic the actual surgical procedure to confirm the device performs as expected.
• Biocompatibility testing: Performed in compliance with ANSI/AAMI/ISO 10993-1: 2009, demonstrating that the materials are suitable for contact with human tissue.

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

The document does not specify the sample sizes used for the design verification tests. It mentions "tests" in plural, implying multiple units were tested, but no specific numbers are given.

The data provenance (country of origin, retrospective/prospective) is also not specified. Given this is a 510(k) submission, the tests were likely conducted by the manufacturer (Ranfac Corp., located in Avon, Massachusetts, USA) as part of their product development and regulatory submission process. It's prospective testing for this specific device.

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

This information is not applicable and not provided in the document. The performance tests described (fluid transfer, centrifugation, ISO compliance, biocompatibility, simulated use) are objective engineering and material science tests, not assessments requiring expert "ground truth" in a clinical diagnostic sense. There is no mention of experts establishing a ground truth for these tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective engineering and material science evaluations, not subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "8. Clinical Data": "Not applicable." This type of study is typically associated with diagnostic imaging devices or algorithms that involve human interpretation and would measure the impact of an AI on human reader performance. This device is a surgical procedure pack, not a diagnostic or interpretation-assistive device.

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

This is not applicable as the Ranfac FATS Procedure Pack is a physical medical device (a surgical procedure pack), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not a relevant concept for this device. Its performance is evaluated through its physical and functional attributes.

7. The Type of Ground Truth Used

For the engineering and material tests, the "ground truth" would be the established specifications, standards (e.g., ISO 7886-1:1993), and risk analysis requirements that the device is designed to meet. For biocompatibility, the ground truth is defined by the ANSI/AAMI/ISO 10993-1 standard. There is no clinical "ground truth" in terms of pathology or outcomes data presented here, as it's a 510(k) submission for a device based on substantial equivalence, not a clinical trial demonstrating efficacy against a disease outcome.

8. The Sample Size for the Training Set

Not applicable. This device is a physical sterile procedure pack, 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 this type of device.

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The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Marrow Cellution Bone Marrow Aspiration Needle consists of a Ranfac Aspiration Needle with Adjustable Guide as well as an additional Aspirator Cannula and a 10ml Syringe. The Marrow Cellution Bone Marrow Aspiration Needle is a single use disposable needle that allows the medical device professional the ability to aspirate from the sides of the needle without aspirating from the needle tip. This allows the needle to be retracted during aspiration ensuring aspirate will not be compromised by the end being open to an area that has already had aspirate removed.

The provided text is a 510(k) summary for a medical device called the "Marrow Cellution Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study for a novel AI/software type of medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, a specific study proving it, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/software device is not applicable to this document.

This document describes a traditional medical device (a bone marrow aspiration needle) and its substantial equivalence to previously cleared predicate devices based on:

1. Similar Indications for Use: The Marrow Cellution Bone Marrow Aspiration Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe, which is similar to the predicate devices.
2. Similar Technological Characteristics: The document provides a table (Table 5.1) comparing design, performance characteristics, cannula configuration, stylet configuration, gauge size, handle configuration, materials, and sterilization methods.
3. Performance Data (Non-Clinical): Design verification tests were performed based on risk analysis and product requirements to demonstrate that the device performed equivalently to predicate devices and is safe and effective when used as intended. These are typically bench tests, not clinical studies in the sense of AI performance evaluation. Biocompatibility testing (ISO 10993-1) was also conducted.
4. No Clinical Data: The document explicitly states "Not applicable" for clinical data. This further confirms that a human-in-the-loop or standalone AI performance study was not conducted or required for this type of device submission.

In summary, this document does not contain the information requested because it pertains to a physical medical device seeking substantial equivalence to existing devices, not an AI or software-as-a-medical-device (SaMD) that would typically undergo the types of performance studies you inquire about.

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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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