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PENTAX Medical Video Duodenoscope ED34-i10T2s: The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

PENTAX Gas/Water Feeding Valve OF-B194: Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.

PENTAX Medical Video Processor EPK-i8020c: The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63: The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.

PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.

The provided document is a 510(k) summary for a medical device (PENTAX Medical Video Duodenoscope ED34-i10T2s and accessories). It outlines the device's characteristics, intended use, and comparison to predicate devices, along with non-clinical performance data.

However, the document does not contain information related to a study proving that an AI device meets acceptance criteria, nor does it provide details about human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for training or test sets related to AI.

The document primarily focuses on demonstrating substantial equivalence of a medical endoscope and its accessories to previously cleared predicate devices through engineering and functional performance testing, reprocessing validation, biocompatibility, electrical safety, and software validation (for a video processor which includes an image enhancement technology, but not an AI diagnostic algorithm in the sense of the prompt's request).

Therefore, I cannot extract the requested information about acceptance criteria for an AI device and related studies from this document. The information you are asking for (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for AI ground truth, MRMC studies for AI, standalone AI performance) is not present in this regulatory submission for an endoscope.

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Luer lock plug for capping male or female luer tapers for hemodialysis catheters.

The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.

The provided document is a 510(k) summary for a medical device called "End Cap". It details the device's description, indications for use, comparison to a predicate device, and performance data for demonstrating substantial equivalence.

However, the questions you've asked are specifically about the acceptance criteria and study proving the device meets acceptance criteria for an AI/ML-enabled medical device. The provided document is for a physical medical device (luer lock plug) and does not involve AI or machine learning. Therefore, the questions related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.

The document discusses performance testing (bench testing) to ensure the physical device meets relevant standards, but this is different from the type of performance evaluation required for an AI/ML diagnostic or predictive device.

Here's how I can address the applicable parts of your request based on the provided document, interpreting "acceptance criteria" in the context of a physical device's regulatory submission:

The "acceptance criteria" for this device's submission revolves around demonstrating substantial equivalence to a legally marketed predicate device by meeting recognized consensual standards for physical device performance and biocompatibility.

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

For a physical device like the End Cap, acceptance criteria are typically defined by compliance with recognized international standards (ISO standards in this case) and demonstrating safe and effective performance. The "reported device performance" is essentially that the device passed these tests, confirming its compliance.

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This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.

Do not use this product for any other purposes.

FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.

The available document is a 510(k) Summary for the FUJIFILM Distal End Cap DC-08D. It details the device's characteristics and compares it to a predicate device (FUJIFILM Distal End Cap DC-07D). However, it does not contain details about a clinical study involving human readers or an AI algorithm’s standalone performance, as the device is a medical accessory, not an AI diagnostic tool.

Therefore, many of the requested sections about acceptance criteria and study details for AI performance are not applicable and cannot be extracted from this document.

Here's the information that can be extracted, along with an explanation for the unavailable sections:

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

The document mentions that "Additional performance specifications were evaluated against pre-determined acceptance criteria" and that "Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use." However, it does not explicitly list the specific acceptance criteria or quantitative performance results in a table format. It only states that the device was evaluated for conformance to ISO 8600-1:2015 and other standards.

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

This information is not applicable as the document describes the regulatory submission for a physical medical device (an end cap), not an AI algorithm requiring a test set of data. The "testing" mentioned refers to bench testing, sterility testing, and biocompatibility testing of the physical product, not data analysis.

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 information is not applicable. Ground truth for data analysis is not relevant for this physical device submission. The "ground truth" for this device would be established by validated engineering and scientific methods and standards (e.g., successful sterilization, material safety, secure attachment), not by expert consensus on data interpretation.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable. The device is an end cap for an endoscope, not an AI system designed to assist human readers.

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

This information is not applicable. The device is a physical medical accessory, not an algorithm.

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

As mentioned, the concept of "ground truth" for data analysis is not applicable here. The verification of the device's properties relies on scientific and engineering testing methods, such as:

• Sterility verification: Based on biological indicators and established sterilization cycles.
• Biocompatibility verification: Based on in-vitro and/or in-vivo tests according to ISO standards.
• Mechanical integrity: Based on bench testing to ensure secure attachment and durability during use.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm and therefore no training set for data.

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

This information is not applicable as there is no AI algorithm and therefore no training set.

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ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.

The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.

The antimicrobial effectiveness was evaluated using in vitro methods and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. It is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.

The ClearGuard HD end cap is male lucr lock end cap that incorporates an antimicrobial treatment on its surfaces. It is designed to reduce microbial colonization within a hemodialysis catheter hub.

The ClearGuard HD end cap consists of 1) a copolyester polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine actate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD end cap is inserted into a liquid-filled catheter, CHA clutes into the catheter lock solution. This CHA solution is designed to reduce the number of microorganisms in the hemodialysis catheter hub.

The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens and minimize the risk of air embolism. These clamps, which are closed when the catheter is not in use, mechanically confine the CHA and prevent diffusion of CHA toward the catheter tip and the patient's bloodstream.

This document describes the 510(k) summary for the Pursuit Vascular, Inc. ClearGuard HD.

The information provided within the input focuses on the submission for a medical device (ClearGuard HD End Cap) for 510(k) clearance based on substantial equivalence, primarily through non-clinical testing. Therefore, many of the typical acceptance criteria and study details for AI/software-based diagnostics (e.g., sample sizes for test sets, expert consensus, MRMC studies) are not applicable in this context.

Here's an analysis of the provided information, addressing what is present and what is not applicable:

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

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail threshold manner for performance metrics like sensitivity or specificity, as one might find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the requirements for demonstrating substantial equivalence to a predicate device.

The reported device performance primarily relates to its antimicrobial effectiveness and safety.

(Note: Not effective against Candida paratropicalis and Klebsiella pneumoniae). The antimicrobial agent (chlorhexidine acetate) is the same as on a reference device (Arrow Antimicrobial Pressure Injectable PICC). |
| Safety: Device is safe for use and introduces no new safety concerns. | Results of design verification and validation testing demonstrate that the ClearGuard HD end cap is safe for use with hemodialysis catheters and reliably seals catheter hubs. It introduces no new or increased safety concerns compared to the predicate and reference devices. The risk assessment results confirm this. |
| Reliable Seals: Ability to reliably seal catheter hubs. | Results of design verification and validation testing demonstrate that the ClearGuard HD end cap reliably seals catheter hubs. |
| Other: Hub compatibility, sterile, non-pyrogenic, single-use. | The device meets these characteristics, making it substantially equivalent to the predicate device in these aspects. |

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

• Not Applicable / Not Provided for Clinical Data: The submission explicitly states: "Not applicable - no clinical data was needed to demonstrate substantial equivalence to its predicate device."
• For the non-clinical (in vitro) testing of antimicrobial effectiveness and safety, the specific "sample size" of individual tests (e.g., number of cultures, number of sealing integrity tests) is not detailed in this summary. The data provenance would be laboratory-based in vitro studies.

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: Given the absence of clinical data and the nature of the device (an end cap with antimicrobial properties), there was no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The effectiveness was assessed through in vitro microbiological methods.

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

• Not Applicable: There was no clinical imagery or diagnostic interpretation requiring 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

• Not Applicable: This is a physical medical device (an end cap), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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)

• Not Applicable / In Vitro Results: For the antimicrobial effectiveness, the "ground truth" was established by in vitro microbiological culture results (i.e., quantifying microbial colonization reduction in laboratory settings). For safety and sealing, it was established by engineering and design verification/validation testing.

8. The sample size for the training set

• Not Applicable: As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not Applicable: There is no training set for this type of device.

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The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation.

The provided text describes a 510(k) summary for a medical device, the "Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension". This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a novel AI/software device would.

Therefore, the document does not contain the information typically required to fill out a table of acceptance criteria and reported device performance for an AI/software device, nor does it describe a study like those requested in questions 2 through 9.

Here's why and what information is available:

• Type of Device: This is an implantable medical device (intramedullary nail end cap), not an AI or software device. Substantial equivalence for such devices often relies on comparison of design, materials, manufacturing processes, and intended use to a predicate device, rather than performance metrics from a clinical study with ground truth.
• Regulatory Pathway: The 510(k) pathway (K082148) for this device is focused on showing substantial equivalence to existing predicate devices (Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System - K081452 and Synthes Elastic Intramedullary Nail (EIN) End Cap - K053105).
• Lack of Performance Data: The 510(k) summary explicitly states "Information presented supports substantial equivalence" but provides no information about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, F-score), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. These are all concepts relevant to the evaluation of AI/software as a medical device (SaMD) or AI-assisted devices, which this product is not.

In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a traditional medical device undergoing a 510(k) substantial equivalence review, not an AI/software device with performance criteria and a study as typically outlined for such technologies.

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The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The Titanium Elastic Nail End Cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation. The threads are self-tapping with reverse cutting flutes to facilitate end cap removal. The back end of the cap is blunt to minimize soft tissue irritation.

This document is a 510(k) summary for the Synthes Elastic Intramedullary Nail (EIN) End Cap. It contains information about the device, its intended use, and its substantial equivalence to predicate devices. However, it does not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any performance data in the way a clinical study would.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

Here is a summary of what is available in the document, demonstrating why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This information is completely absent. No acceptance criteria are stated, and no performance metrics (e.g., accuracy, sensitivity, specificity, or any other quantifiable measure) are reported for the device.

2. Sample size used for the test set and the data provenance: This information is completely absent. There is no mention of a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent. There is no mention of experts or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is completely absent.

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: This information is completely absent. The device described is a physical medical implant (an end cap for an intramedullary nail), not an AI-assisted diagnostic or decision support tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is completely absent. As mentioned, this is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is completely absent.

8. The sample size for the training set: This information is completely absent.

9. How the ground truth for the training set was established: This information is completely absent.

Conclusion:

The provided document is a regulatory submission for a medical device (Synthes Elastic Intramedullary Nail (EIN) End Cap) seeking 510(k) clearance. The purpose of a 510(k) summary is to demonstrate "substantial equivalence" to a predicate device, which primarily involves comparing design, materials, and intended use, rather than presenting detailed clinical performance data from a prospective study with acceptance criteria.

Therefore, the specific information you requested regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement for performance evaluation is not available in this document. Such details would typically be found in a separate clinical or non-clinical performance study report, which is not part of this 510(k) summary.

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