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The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids.

The BIOTEO Drainage Catheter Set (Seldinger Type), BT-PDS-series percutaneous drainage catheter with hydrophilic coating, are percutaneous drainage catheters used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or close loop and drainage holes.

The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator should use Seldinger Technique to provide access.

The document is a 510(k) summary for the BIOTEQ Drainage Catheter Set (Seldinger Type), K210419. This document pertains to a medical device (catheter set) and not an AI/ML powered device. As such, information regarding AI/ML specific criteria such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in the provided text.

Therefore, I cannot provide a response for the requested information as it is not contained in the provided document. The document describes non-clinical performance data for substantial equivalence with a predicate device, focusing on sterilization, shelf-life, biocompatibility, and general performance testing against various ISO and ASTM standards.

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The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

The BIOTEQ Drainage Catheter Set (One Step Type), BT-PD1-series percutaneous drainage catheter with hydrophilic coating, is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a "J", a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either Direct Access Technique or Seldinger Technique to provide access.

The provided document is a 510(k) summary for a medical device (BIOTEQ Drainage Catheter Set (One Step Type)). It details the device's indications for use, description, and a comparison to predicate devices to establish substantial equivalence.

However, the document explicitly states in "5.10 Clinical Testing" that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the details requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria from this document, as no clinical testing was performed or submitted for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies is presented.
2. Sample sizes used for the test set and the data provenance: No test set was used for clinical performance evaluation.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no clinical ground truth was established by experts.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
9. How the ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (Sterilization Validation, Shelf-life, Biocompatibility, Performance) to demonstrate substantial equivalence to legally marketed predicate devices, rather than clinical performance data against specific acceptance criteria. The "Performance" referred to in Section 5.9 is likely related to physical performance characteristics of the device (e.g., flow rate, material strength, radiopacity, etc.), and not clinical outcomes.

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The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).

The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.

The provided document describes the 510(k) premarket notification for a Sheath Introducer device, demonstrating its substantial equivalence to a legally marketed predicate device. This is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

• The device: Sheath Introducer, used for percutaneous introduction of devices into veins/arteries.
• The testing conducted: Sterilization validation, biocompatibility, and various performance tests (e.g., force at break, leakage, radiopacity, insertion force, guidewire compatibility, kink resistance).
• The comparison: The proposed device is compared to the Merit Prelude™ Sheath Introducer (K050962).
• The determination: The FDA found the device substantially equivalent based on intended use, design, technology/principles of operation, and performance.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device testing (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, standalone performance) cannot be answered from this document.

This document specifically states: "No clinical test data was used to support the decision of the substantial equivalence." and focuses on bench testing and material comparisons.

However, if we interpret "acceptance criteria" and "study" in the context of this specific medical device (a physical sheath introducer) as a substantial equivalence determination, then the information would be as follows:

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

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

• Sample size: Not explicitly stated for each test, but standard test methods for medical devices typically involve specific sample sizes per ISO/ASTM standards.
• Data provenance: Not specified beyond "A series of tests were performed." The tests are non-clinical, meaning they were conducted in a laboratory setting. No indication of country of origin for the data itself, but the manufacturer is in Taipei, Taiwan. The tests are "retrospective" in the sense that they are conducted on manufactured samples, not "prospective" clinical trials.

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 undergoing bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established engineering and material science standards and measurement techniques.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against pre-defined engineering and material standards, not subjective expert judgment.

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 a physical, non-AI medical device. No human-in-the-loop performance or AI assistance involved.

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

• Not applicable. This is a physical, non-AI medical device.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is derived from established engineering and material science standards (e.g., ISO, ASTM standards for medical devices), physical measurements, and chemical analyses. For instance, a "force at break" test's ground truth is the measured force value compared to an acceptable range.

8. The sample size for the training set:

• Not applicable. This is a physical, non-AI medical device. There is no "training set" in the context of machine learning.

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

• Not applicable. There is no training set or machine learning "ground truth" for this device.

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The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.

The BIOTEO® ANGIOGRAPHIC CATHETER is with the braided proximal shaft. The distal shaft of the catheter has variety configuration and the tip is made soft to minimize trauma to the vessel wall. It consists of the following major components: Soft Tube, Braiding tube, Screw Cap, F.L.L. Adapter, Adaptor Butterfly.

The provided document pertains to the 510(k) premarket notification for the BIOTEQ® ANGIOGRAPHIC CATHETER. This is a medical device and the document describes performance testing rather than a study typically associated with AI/ML devices that would involve acceptance criteria, sample sizes for test/training sets, ground truth establishment, or expert reviews for diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and studies typical for AI/ML devices (e.g., sample sizes for test/training sets, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be extracted from this document, as it focuses on the physical and biological performance of a catheter.

Here's a breakdown of the performance testing conducted for this device, which serves a similar purpose to acceptance criteria for traditional medical devices:

1. Table of Acceptance Criteria and Reported Device Performance (based on performance testing, not AI/ML metrics):

The study supporting these criteria:

The document states: "Performance testing was conducted on the BIOTEO® ANGIOGRAPHIC Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993."

Missing Information (as per AI/ML context):

The following points are not applicable or not provided in the context of this traditional medical device submission for an angiographic catheter:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical and biological characteristics does not involve "test sets" in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and biological testing standards.
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. This device is not an AI/ML diagnostic tool for human readers.
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.): The "ground truth" for this device's performance is defined by established engineering standards, material science properties, biocompatibility guidelines (e.g., ISO 10993), and functional performance specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.

The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components: ① F.L.L. Adapter ② Screw Cap ③ Catheter ④ Curve Straightener (Sleeve) ⑤ Wire Cap --- (For With Safety String Lock model only) ⑥ Trocar Stylet ⑦ Trocar Needle ⑧ Sheath ⑨ Suture Wire --- (For With Safety String Lock model only)

Here's a breakdown of the acceptance criteria and the study information for the BIOTEQ® Pigtail Drainage Catheter Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance in general terms rather than specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not explicitly stated. The document indicates "bench testing" was performed, but the number of units tested is not specified.
• Data Provenance: Not explicitly stated, but given the manufacturer (BIOTEQUE CORPORATION) is in Taiwan, it's likely the testing was conducted by or for the manufacturer. The testing is described as "bench testing," which refers to in-vitro laboratory tests, not human data. Therefore, the data would not have a country of origin in the context of patient data, nor is it retrospective or prospective.

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

• Number of Experts: Not applicable. The "ground truth" for this type of device (a medical catheter set) is established through performance against industry standards and specifications during bench testing, not through expert interpretation of a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. As the testing involves objective measurement against engineering and biological standards, there is no need for expert adjudication.

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:

• MRMC Study: No. This is a medical device (catheter set), not an AI-powered diagnostic or interpretive tool. Therefore, a multi-reader multi-case comparative effectiveness study or AI assistance is not relevant or applicable.

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

• Standalone Performance Study: Not applicable. This device does not involve an algorithm. The study described is bench testing of the physical, chemical, biological, and sterilization properties of the catheter set.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for this device's performance is derived from established international and national standards for medical devices, specifically for physical, chemical, biological compatibility, and sterility. Examples include ISO 10993 series, ISO 11607-1, ISO 11135, and USP Pyrogenic standards.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable.

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BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.

The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The Pusher Catheter (Introducer sheath) is approximately 45cm long. The Guide Wire (Spiral stylet) is made of stainless steel with PTFE coating and a flexible safety tip and a marked rigid tip and is approximately 120 cm long. The plastic dispenser is used to protect the Guide Wire (Spiral stylet). There are also plastic clips in the set.

The provided text describes a 510(k) summary for the BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET. For medical devices, particularly those submitted under 510(k), the "acceptance criteria" and "study" typically refer to demonstrating substantial equivalence to a legally marketed predicate device through bench testing, performance testing, and adherence to relevant standards, rather than clinical studies with human participants that establish a device's performance in terms of diagnostic accuracy or effect sizes.

Based on the provided text, here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: The document does not specify a "sample size" in the context of a traditional test set with individual patient cases or data points. The assessment is based on bench testing and adherence to standards for the device itself and its material properties.
• Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the bench tests and compliance with international standards for manufacturing, materials, and sterilization.

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

• This information is not applicable to this 510(k) submission. The "ground truth" for a medical device cleared via 510(k) is typically established by demonstrating that the device meets engineering specifications, material standards, biocompatibility requirements, and sterilization efficacy, which are evaluated by technical experts, engineers, and regulatory bodies against established standards, not clinical experts establishing diagnostic "ground truth" for a dataset.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for diagnostic devices, to resolve discrepant expert opinions on case classifications. This 510(k) relies on bench testing and adherence to standards, which do not involve such adjudication.

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. This type of study is relevant for diagnostic imaging devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is an implantable medical device, not a diagnostic imaging or AI-enabled device.

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

• No, a standalone algorithm performance study was NOT done. This device is a physical medical instrument (ureteral stent) and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is defined by engineering specifications, material safety and performance standards (e.g., ISO, USP), and biocompatibility requirements. It's about meeting pre-defined physical, chemical, and biological performance benchmarks, not clinical outcomes or pathology.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this device does not utilize machine learning or AI algorithms. The device undergoes manufacturing processes and quality controls to ensure each unit meets the required specifications.

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

• Not applicable. As there is no training set involving algorithms, there is no ground truth to be established for it. The "ground truth" for the device's design and manufacturing is established through adherence to recognized international and national standards and regulatory requirements.

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The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX consists of the following major components: ① Protection Cap ② Needle Cannula ③ Butterfly Wing ④ Needle Hub ⑤ Safety Flex ⑥ Small Pinch Clamp ⑦ PVC Tubing ⑧ Female Luer ⑨ Cap for Female Luer These components assembled together as BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis procedures. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge, 17 gauge.

The provided document is a 510(k) summary for a medical device called the BIOTEQ® A. V. FISTULA NEEDLE SET WITH SAFETY FLEX. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria related to device performance in a clinical setting.

Therefore, the document does not contain detailed information about acceptance criteria or a study proving the device meets them in the way clinical performance studies typically do. Instead, it focuses on demonstrating that the device meets safety and effectiveness requirements by conforming to applicable standards and showing equivalence to a legally marketed predicate device.

Here's a breakdown of the information that is and is not available based on your request:

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

• Not Applicable in the traditional sense. This 510(k) summary does not present specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for an AI device) or reported performance metrics against such criteria.
• What is reported: The document states, "In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards". This is the closest equivalent to "acceptance criteria" here, indicating that the device meets established industry standards for these categories.

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

• Not Provided. This information is not typically included in a 510(k) summary focused on substantial equivalence through bench testing. The "test set" here refers to "bench testing" rather than a clinical dataset.
• The document mentions "bench testing contained in this submission," but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. For a device like an A.V. Fistula Needle Set, "ground truth" is not established by human experts in the same way it would be for an AI diagnostic device evaluating images. Device performance is assessed against engineering and biological standards.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus is needed to establish ground truth, which is not the case for the type of testing described (physical, chemical, biological, sterilization specifications).

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. This type of study is relevant for AI-powered diagnostic devices, not for a physical medical device like a needle set.

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

• Not Applicable. This device is a physical medical instrument, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device itself is "standalone" in its function.

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

• Ground truth for this device type is based on established engineering, biological, and sterilization standards. For example, "Physical specification" would refer to tensile strength, needle sharpness, flow rates; "Chemical specification" to material composition and biocompatibility; "Biological specification" to absence of certain toxins, and "Sterilization Specification" to sterility assurance levels.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of device. The document describes a manufactured product, not an AI/ML algorithm that requires training.

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

• Not Applicable. As there is no training set for this device type, the establishment of ground truth for it is irrelevant.

Summary of the Study (as described in the 510(k)):

The study described is bench testing to demonstrate substantial equivalence to a predicate device (JMS A.V. FISTULA NEEDLE WingEater, K 010406).

• Purpose: To show that any differences in technological characteristics between the BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX and the predicate device "do not raise any new questions of safety or effectiveness."
• Methods: The device was tested "in terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification." It "conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards."
• Conclusion: Based on this bench testing and comparison of intended use and technological characteristics, the device was deemed "substantially equivalent to the predicate devices."

In essence, this 510(k) summary provides evidence of compliance with established standards and equivalence to a predicate, rather than reporting on a clinical trial with specific performance metrics against defined acceptance criteria.

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The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).

The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-102DB、BT-102DC、BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items: An intravenous administration set for use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-102DA 、BT-102DB、BT-102DC、BT-102DD)

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way requested for AI/diagnostic devices. The information provided heavily emphasizes physical, chemical, biological, and sterilization specifications rather than clinical performance metrics often associated with "device performance" in the context of diagnostic or AI-driven tools.

Therefore, the requested table of acceptance criteria and reported device performance, and several other points (2, 3, 4, 5, 6, 7, 8, 9), cannot be directly extracted or are not applicable from the provided text in the way they would be for a typical AI/diagnostic device study. The text primarily focuses on conformity to standards and substantial equivalence.

Here's an analysis 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 (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench testing," but it does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood tubing pack, and its evaluation relies on engineering, material, and sterility testing against established standards, not expert interpretation of outputs like an AI diagnostic tool.

4. Adjudication method for the test set
Not applicable. The evaluation is based on conformance to engineering and safety standards, not a diagnostic interpretation process requiring adjudication.

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 or diagnostic device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation focuses on the physical and biological characteristics of the blood tubing pack itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established international and national standards for medical device safety, material compatibility, and sterilization (e.g., ISO 10993 series for biological evaluation, ISO 11607-1 for packaging, ISO 11135 for sterilization, USP Pyrogenic standards).

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.

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BIOTEQ® SCALP VEIN SET act as a pathway to administer parenteral fluid/ medication into the patient's vascular system.

BIOTEQ® SCALP VEIN SET (BS-120 (22G); BS-121(23G) ; BS-122(24G))consist of the following 5 major components: Protective cap for needle, the stainless needle, the plastic butterfly wing , the PVC Tube, the PVC safety Cap. These 5 major components assembled together as SCALE VEIN SET for use as a pathway to administer medical fluid from extracorporeal system through the device into venous blood.

The provided text is a 510(k) summary for the BIOTEQ® SCALP VEIN SET. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Instead, the submission relies on demonstrating substantial equivalence to already approved predicate devices through bench testing that confirms physical, chemical, biological, and sterilization specifications.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as this is not the type of study described.

Here's a breakdown of the information that is available based on your request:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/diagnostic device. The "bench testing" likely refers to laboratory-based evaluations of the device's components and assembled product against engineering and safety standards. The provenance (e.g., country of origin, retrospective/prospective) for this bench testing is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a device like a scalp vein set, "ground truth" typically relates to objective measurements against established engineering and safety standards, rather than expert interpretation of data.

3. Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is described for this type of bench testing.

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: Not applicable. This document pertains to a medical device (scalp vein set), not an AI diagnostic tool involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ISO, USP), and functional performance requirements for medical devices of this type. It's objective, measurable criteria rather than subjective expert consensus or clinical outcomes data in the typical sense.

7. The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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