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The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.

The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths.

The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

Based on the provided FDA 510(k) clearance letter for the Boston Scientific Corporation's Ureteral Stents and Urinary Diversion Stent Sets (K250824), it's important to note that no study or specific performance criteria are detailed in this document.

This 510(k) is a "Special 510(k) ", which is used when changes to a legally marketed device do not affect its safety or effectiveness. The key takeaway from Section J (Performance Testing) and Section I (Substantial Equivalence) is:

• Changes are limited to labeling updates. The submission explicitly states: "The changes proposed within this bundled Special 510(k) are to the labeling for the proposed devices. There are no changes in design, performance, operating principle, or fundamental technology being proposed within this premarket notification."
• No new testing was required: "Therefore, existing test information/data remains valid for the proposed devices. No additional Verification or Validation testing was required for the changes to the labeling."
• Substantial Equivalence based on existing data: The conclusion reiterates that "Based on the intended use/indications for use, operating principle and comparison of key technological characteristics presented in this premarket notification, it is concluded that the proposed Ureteral Stents and Urinary Diversion Stent Set are substantially equivalent to the predicate device (cleared under K190603)."

Therefore, the document does not contain the information required to populate the sections you requested regarding acceptance criteria and a study proving the device meets those criteria, because no new performance testing was conducted for this specific 510(k) submission.

Here is a table explaining why each of your requested points cannot be answered from this specific 510(k) submission:

In summary, the provided 510(k) document (K250824) is a regulatory clearance for minor changes (specifically labeling updates) to existing, already cleared medical devices. It explicitly states that these changes do not require new performance testing, and therefore, it does not contain the details of studies, acceptance criteria, or ground truth establishment that would be present in an original 510(k) submission for a novel device or a device with significant design changes or a software/AI component. The "proof" of meeting acceptance criteria for these devices relies on the data submitted and reviewed for the predicate device (K190603).

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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

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

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

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

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The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife.

The provided text describes the regulatory clearance of a surgical stapling device, the da Vinci SP SureForm 45 Staplers and Reloads, but does not contain information about an AI/ML powered medical device or the specific metrics, studies, and expert review processes associated with such devices.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) as it pertains to AI/ML device evaluations.

The document discusses the following types of studies:

• Design Verification (Bench Testing): Included physical specifications, mechanical requirements, electrical requirements, user interface requirements, equipment interface requirements, reliability, and packaging/labeling. The device met all acceptance criteria.
• Design Validation (Animal Studies): Acute validation studies using simulated clinical models (animal) to evaluate performance. This included:
  • Staple Line Performance: Assessed staple line performance and staple formation.
  • Leak Onset Pressure: Assessed leak onset pressure performance on ex vivo tissue.
  • Design Validation Testing: Performed in a clinical laboratory setting.
• Human Factors Evaluation: Included analysis of use-related issues (MAUDE database), Comparative Task Analysis (CTA), Use-Related Risk Analysis (URRA), formative usability evaluations, and summative usability validations.

These studies are typical for mechanical surgical devices and do not involve AI/ML performance metrics or associated ground truth establishment by experts in the context of diagnostic or interpretive tasks.

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The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.

The provided text describes the non-clinical and clinical tests performed to demonstrate the substantial equivalence of the SureWave Elastography device to its predicate devices. However, it does not explicitly define acceptance criteria in a table format with specific thresholds. It rather focuses on demonstrating similarity and accuracy to known values and predicate devices.

Based on the information provided, here's a structured response, with some sections noting what information is not present in the document.

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

The document does not explicitly state acceptance criteria in a quantitative table format with predefined thresholds. However, the study aims to demonstrate accuracy and repeatability comparable to, or better than, the predicate device and known phantom values. The reported performance is summarized below:

• Computed stiffness values were "at least as accurate if not more accurate than the predicate method." |
  | Specific Phantom Values: | | | | |
  | Expected: 0.82 kPa | Close to 0.82 kPa | 0.76 ± 0.01 kPa (95% CI) | 0.73 ± 0.02 kPa (95% CI) |
  | Expected: 2.02 kPa | Close to 2.02 kPa | 2.53 ± 0.94 kPa (95% CI) | 2.01 ± 0.07 kPa (95% CI) |
  | Expected: 2.77 kPa | Close to 2.77 kPa | 3.83 ± 0.44 kPa (95% CI) | 3.27 ± 0.32 kPa (95% CI) |
  | Expected: 5.80 kPa | Close to 5.80 kPa | 5.80 ± 0.67 kPa (95% CI) | 5.20 ± 0.09 kPa (95% CI) |
  | Repeatability | Within 10% of the mean of the respective method, and comparable/better than predicate. | Within 10% of the mean. | Within 10% of the mean. | "Slightly better than that of the predicate." |
  | Equivalency to Predicate (SureWave 2D) | Strong agreement with predicate, low bias. | Linear regression slope: 1.02 (R² = 0.99). Bland-Altman bias: 4%. | Not applicable. | "Excellent agreement," "no significant difference observed," "equivalent." |
  | Equivalency to Predicate (SureWave 3D) | Strong linear relationship. Expected bias due to volumetric analysis. | Not applicable. | Linear regression R² = 0.99. Bland-Altman bias: approximately 20%. | "Strong linear relationship." Bias expected and potentially indicates more accuracy. |

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

• Accuracy Test (Phantom):
  • Sample Size: Not explicitly stated as a "sample size" for a test set, but referred to as "MRE acquisitions from SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods." The number of acquisitions per method for the general QA phantom repeatability testing was 240 measurements. It is implied similar extensive measurements were taken for the multi-component QA phantom.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The phantom study is a bench test, not human data.
• Equivalency Test (Volunteer):
  • Sample Size: 22 healthy adult volunteers.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "healthy adult volunteers," implying a prospective human study.

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

• Phantom Studies: Ground truth for the phantom was established by the phantom manufacturer ("expected stiffness values established by the phantom manufacturer"). No human experts were involved in establishing this ground truth.
• Volunteer Studies: For the healthy volunteer equivalency study, the "ground truth" was effectively established by the predicate device's measurements. The document states that the SureWave Elastography measurements were plotted against the predicate device to assess their relationship and bias. No independent expert consensus or interpretation was described as establishing a separate ground truth for this human volunteer data beyond the predicate device as the comparison standard.

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

• No adjudication method (e.g., expert consensus or multi-reader review beyond the device's output) is described for either the phantom or volunteer test sets. The focus appears to be on direct numerical comparison of the device's output against known phantom values or predicate device measurements.

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 MRMC comparative effectiveness study involving human readers and AI assistance is described. The study focuses on the device's performance in terms of stiffness measurement accuracy and repeatability, and its equivalence to a predicate device, not on diagnostic improvement for human readers. The device outputs images that are "interpreted by a trained physician," but the study does not evaluate this physician interpretation process.

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

• Yes, the conducted tests, precisely the phantom and volunteer studies, evaluate the standalone performance of the SureWave Elastography device in generating stiffness measurements. The device produces quantitative stiffness values (kPa) and qualitative stiffness maps, confidence overlays, and wave images. The accuracy and repeatability of these outputs were directly assessed. While a trained physician interprets the images, the study's focus is on the device's ability to accurately produce those measurements, independent of a specific physician's interpretation improvement.

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

• Phantom Studies: The ground truth was known physical properties of the phantom components, as provided by the phantom manufacturer.
• Volunteer Studies: The ground truth for comparison was the measurements obtained from the legally marketed predicate device.

8. The sample size for the training set

• The document does not provide information about a training set size. The described tests relate to the validation or verification of the device's performance, implying it has already been developed. As this is a 510(k) submission for a device that generates physical properties (stiffness) rather than AI-based diagnostic interpretations, it's possible a separate "training set" in the machine learning sense was not explicitly required or detailed in this summary.

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

• As no training set is described, information on how its ground truth was established is also not present in the document.

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The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The document (K242049) is a Traditional 510(k) Summary for the Coloplast SureCath Set, a sterile, single-use hydrophilic coated intermittent catheter with an integrated urine bag. It demonstrates substantial equivalence to predicate devices. The information provided primarily focuses on non-clinical performance testing rather than human clinical studies involving AI assistance.

Based on the provided text, the device SureCath Set is a medical device, not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI, or standalone algorithm performance are not applicable.

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

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

The document broadly states that "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." It also mentions various ISO and ASTM standards to which the device was tested. However, it does not explicitly list specific quantitative acceptance criteria or detailed reported performance values for each test. It only states that the device "met the pre-determined acceptance criteria."

Implicit Acceptance Criteria (based on standards and test descriptions):

• Strength of connection between catheter and urine bag.
• Aseptic insertion (non-touch approach) of catheter through urine bag.
• Water amount of 20 ml in ampoule must activate coating on catheter.
• Friction of the coated catheter after 30 seconds activation time.
• Tearing and emptying of the urine bag.
• Volume of the urine bag.
• Strength of the urine bag. |
  | Usability | Met acceptance criteria per EN/IEC 62366-1. |
  | Packaging Integrity | Met acceptance criteria per ISO 11607-1, DS EN ISO 20696, ASTM D4169-22 for maintenance of sterile barrier and impact of transportation. |
  | Shelf Life/Aging Stability | Met acceptance criteria after accelerated aging per ASTM F1980-21, demonstrating stability for the defined shelf life (24 months at time of submission, planned 36 months). |

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

The document does not specify the exact sample sizes used for each non-clinical test. It states "Testing was performed on final, finished, and sterilized devices." The provenance of the data is from Coloplast A/S, Denmark. The tests are non-clinical, bench performance tests, so the concepts of "retrospective or prospective" human data don't directly apply here.

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 type of non-clinical device testing. There are no "experts" establishing a "ground truth" for a test set in the way it would be for an AI/ML clinical study (e.g., radiologists interpreting images). The "ground truth" for non-clinical tests is based on objective measurements against established engineering and biological standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. Non-clinical bench tests rely on objective measurements against defined standards.

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 conducted. The device is a physical medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, there is no "AI assistance" for human readers to improve upon.

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

No, a standalone algorithm-only performance study was not done. The device is not an algorithm or software requiring human-in-the-loop performance.

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

The "ground truth" for the non-clinical tests is based on:

• Compliance with recognized international standards (ISO, ASTM, EN/IEC).
• Pre-determined acceptance criteria defined by Coloplast for specific performance aspects (e.g., strength, friction, volume, activation).
• Objective measurements of physical and chemical properties.

8. The sample size for the training set

This information is not applicable. "Training set" is a concept for AI/ML models. This document describes testing for a physical medical device.

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

This information is not applicable, as there is no training set for a physical medical device.

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The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types.

The provided document is a 510(k) summary for the Intuitive Surgical 8mm SureForm 30 Stapler and Reloads. It outlines the device description, indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific reported device performance values, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, training set sizes, or how training set ground truth was established for the device.

The document indicates that design verification, compatibility verification, transit verification, biocompatibility, design validation (simulated clinical use), and human factors testing were performed. It states, "The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs."

Since the detailed information you requested is not present in the provided text, I cannot complete the table or answer points 2-9. The document focuses on demonstrating substantial equivalence rather than providing a detailed technical report of specific performance metrics against acceptance criteria for a new AI/software device.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:

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

Missing Information for Table: The document doesn't provide specific numerical acceptance criteria (e.g., "staple height +/- 0.1mm") or quantitative performance results (e.g., "average staple height was X mm with a standard deviation of Y mm"). It only states that testing was "successful" and criteria were "met."

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

• Sample Size: Not specified for any of the tests (design verification, transit, biocompatibility, design validation, human factors).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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):

• This is not applicable as the document describes a surgical stapling device, not an AI/software device that requires expert-established ground truth on medical images or data. The "ground truth" for this type of device would be physical measurements and performance against engineering specifications. No experts are mentioned in this context.

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

• Not applicable for this type of device submission. Adjudication methods are typically associated with expert review of medical data for AI/software evaluations.

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 surgical stapling device, not an AI-assisted diagnostic or therapeutic device for human readers.

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

• Not applicable. This is a physical medical device.

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

• For a surgical stapler, the "ground truth" would be established by engineering specifications, physical measurements (e.g., staple formation, cutting efficiency), and functional performance in simulated tissue models. The document refers to "functional design inputs" and "product specifications" rather than medical ground truth sources like pathology.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model.

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

• Not applicable. This is a physical medical device, not a machine learning model.

In summary, the provided document is a 510(k) submission for a surgical stapler, which is a physical medical device. The detailed information requested in points 2-9 typically applies to AI/software as a medical device (SaMD) clearances or approvals, which involve data sets, ground truth establishment by experts, and performance evaluation of algorithms. The submission confirms that the device underwent standard physical device testing (mechanical, biocompatibility, usability) and met its design inputs, demonstrating substantial equivalence to its predicate.

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The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.

The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.

The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.

The provided text is a 510(k) summary for the reprocessing of medical devices, specifically VersaCross Steerable Sheaths and SureFlex Steerable Guiding Sheaths. It describes the regulatory review process and confirms that the reprocessed devices are substantially equivalent to their predicate devices.

However, the document does not describe a study that proves a device meets acceptance criteria using an AI/algorithm-driven component. The entire document discusses the reprocessing of physical medical devices and their functional and safety testing to establish substantial equivalence, not the performance of an AI or software-based device.

Therefore, I cannot extract the information required to answer your prompt questions about acceptance criteria for an AI device, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets, because this information is not present in the provided text.

The closest relevant information relates to functional and safety testing of the reprocessed physical medical devices, which is presented as:

Functional and Safety Testing (of physical reprocessed catheters):

Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:

• Biocompatibility
• Cleaning Validation
• Sterilization Validation
• Functional Testing
  • Visual Inspection
  • Dimensional Inspection
  • Tip Deflection
  • Tip Buckling
  • Valve/Joint leak
  • Radiopacity
  • Simulated Use
  • Torque Testing
  • Tensile Testing
  • Corrosion Testing
• Packaging Validation

This list represents the acceptance criteria (or areas of testing) for the reprocessed physical device, not an AI or software device. The document does not provide specific numerical performance metrics for these tests, nor does it detail sample sizes, expert involvement, or adjudication methods for these physical device tests in the way your prompt requests for an AI study.

In summary, the provided text does not contain any information about an AI/algorithm-driven device or a study related to its performance against acceptance criteria.

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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.

The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.

Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.

Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.

Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:

Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles

The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
• Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.

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

This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.

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

No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
• Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
• Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.

The provided document, K230891, describes the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and its substantial equivalence to a predicate device. However, the document does not contain acceptance criteria for the device's performance, nor does it detail a specific study proving the device meets said criteria with the requested level of detail for an AI/ML medical device.

The provided text focuses on the 510(k) submission for a physical medical implant (a suture and PEEK button for meniscus repair) and its comparison to a predicate device, rather than an AI/ML-driven device. As such, information regarding test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set (all typical for AI/ML device evaluations) are absent.

Here's an analysis based on the information that is available in the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "pull-out strength must be X N"). Instead, it states the conclusion of the test:

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

• Sample Size: Not specified for the pull-out strength, cyclical loading, bacterial endotoxin, or packaging tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are non-clinical, likely bench testing.

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

Not applicable. The tests performed are non-clinical mechanical and biological compatibility tests, not evaluations that require expert interpretation of results to establish ground truth in the context of an AI/ML device.

4. Adjudication method for the test set

Not applicable. This concept is relevant for AI/ML performance ground truth establishment, not for the types of non-clinical tests described.

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/ML device. The study described compares the subject device's mechanical performance to a predicate device, not human reader performance with or without AI assistance.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the non-clinical tests described:

• Mechanical Performance (Pull-out strength, Cyclical loading): The "ground truth" is measured physical properties and comparison to a predicate device's measured physical properties.
• Biological Compatibility (Bacterial Endotoxin): The "ground truth" is adherence to established pyrogen limit specifications (USP ).
• Packaging: The "ground truth" is the confirmation of sterile barrier integrity and product protection during simulated conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.

The proposed SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath subject devices are non-pyrogenic, single use devices that are supplied sterile to the UD Steerable Sheath families are comprised of the following components that are packaged together:

• . One Steerable Sheath
• . One Transseptal Dilator
• . One J-tip Mechanical Guidewire

The SureFlex and VersaCross HD Steerable Sheaths are intended for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with separately cleared impedancebased electroanatomical mapping (EAM) systems. The steerable sheath component used in conjunction with a compatible transseptal dilator can facilitate transseptal puncture using separately cleared compatible needle or wire-based puncture devices. The steerable sheath component is connected to the impedance-based EAM system via a compatible legally marketed accessory cable. The subject device is used in a sterile environment where facilities are appropriately equipped and staffed to perform transseptal procedures.

The steerable sheath component is 8.5 Fr with a 63 cm or 73 cm useable length and is available in three curve options (small, medium, large). It is flexible and bi-directionally deflectable at the distal end (180 degrees clockwise and counterclockwise). The radiopaque tip (containing a platinum/iridium marker band) maximizes visualization of the sheath during manipulation. The sheath contains 4 electrodes equi-spaced along the shaft to enable shaft visualization. The sheath has two distal sideports and the proximal end includes a hemostasis valve and a 3-way stopcock to facilitate the injection or fluids. A silicone lubricant is applied to the outer surface of the shaft for smoother device manipulation. The sheath handle allows the user to control the deflection of the sheath tip through rotation of the knob in the direction of desired distal deflection.

The compatible dilator component is 8.5F with a 95cm usable length and is comprised of HDPE material with a tungsten radiopaque marker coil at the tip for visualization. The dilator has a tapered distal tip that provides support for the sheath. The compatible mechanical guidewire (0.032″ or 0.035″) component is J-tipped, 180 cm in length and is comprised of a stainless-steel core mandrel with a PTFE coating.

The provided document is a 510(k) Premarket Notification for medical devices, specifically steerable sheaths (SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath). It details the substantial equivalence determination made by the FDA.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product. The medical devices in question are physical catheters/sheaths, and the performance testing summarized refers to mechanical, electrical, biocompatibility, sterilization, pyrogen, and packaging testing, as well as a simulated-use animal study. These are typical validation activities for a physical medical device.

The only mention of "visualization" or "mapping systems" is in the context of the sheath's curve being visualized when used with impedance-based electroanatomical mapping systems, and the predicate device's compatibility with CARTO® 3 EP Navigation Systems. This refers to the ability of the physical sheath to be seen on separate, compatible systems, not an AI or SaMD performing a diagnostic or therapeutic function itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical medical device.

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