Search Results

Used for the treatment of abscesses and cysts of the Bartholin gland.

The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.

Here's an analysis of the provided information regarding the Word Catheter-Silicone Bartholin Gland Balloon Set, structured to address your specific requests:

The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical outcomes or performance against a predefined threshold. Instead, it focuses on demonstrating equivalence through technical comparisons and standard engineering/biocompatibility testing.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria for a novel device, the "acceptance criteria" are predominantly related to manufacturing and material standards, as well as functional equivalence to predicate devices.

Important Note: The document does not specify quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or quantitative performance results for the device. Instead, it states that the device was tested according to recognized standards and demonstrated substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it meets these standards and is equivalent to a legally marketed device.

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

• Sample Size: The document does not specify a "test set" of patient data or clinical samples. The testing described is primarily non-clinical (bench testing) and biocompatibility for the device itself.
• Data Provenance: Not applicable, as this is a non-clinical submission. The testing was conducted in a laboratory setting.

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

• Not applicable. This submission focuses on the technical characteristics and safety of a medical device (catheter) through bench testing and material biocompatibility, not on a diagnostic algorithm or interpretation requiring expert review of data. There is no "ground truth" to be established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. As there is no clinical test set or expert review process, no adjudication method was used.

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. This information is not present in the document. The device is a physical medical instrument (catheter), not an AI-assisted diagnostic or interpretive tool.

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

• Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used

• Not applicable. In the context of a medical device like a catheter, "ground truth" often refers to fundamental scientific principles, engineering standards (like those for materials strength or biocompatibility), and the established performance characteristics of the predicate devices. There is no patient-specific "ground truth" in this submission.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."

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

• Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set" with ground truth.

Ask a specific question about this device

Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.

The 3 Way Silicone Foley Balloon Catheter is composed of a silicone tube with an imbedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve. The tube has three lumens, one lumen for urinary drainage which is to be connected to urine collection container, one lumen with two-way valve for inflation/deflation of Foley balloon and one lumen for irrigation of bladder. Catheter is available in 16, 18, 20, 22, 24, 26 French with 30 cc balloon. Catheter is available in open or closed end. Open end allows for use of wire quide available separate). The 3 Way Silcone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy.

The devices are provided sterile and are intended for one time use.

The provided text is a 510(k) summary and FDA clearance letter for a medical device (3 Way Silicone Foley Balloon Catheter). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, device performance metrics, or the study design typically found in a clinical trial or performance study report for AI-powered devices.

Therefore, I cannot provide the requested information in the format you specified. The information regarding sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text because this is a traditional medical device, not an AI device.

Here's what I can infer from the document:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in terms of quantitative metrics. The document broadly states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidances and recognized international standards." This indicates that the device met the established standards for these types of tests, but specific pass/fail criteria or numerical results are not provided.
• Study Type: The testing performed was likely focused on demonstrating the physical, chemical, and biological properties of the catheter, and its ability to function as intended (e.g., balloon inflation, fluid drainage/irrigation pathways). It was not a study to evaluate an AI algorithm.
• Ground Truth: For a traditional device like this, "ground truth" would be established by validated test methods and reference standards for material properties, sterility, and mechanical performance, not by expert consensus on clinical images or outcomes data in the context of an AI study.

In summary, the provided document does not support the detailed breakdown requested for an AI device study.

Ask a specific question about this device

The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.

The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.

The provided text describes a medical device, the Cook® Fetal Membrane Manipulator, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or the specifics of a study that proves the device meets those criteria.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The specific quantitative or qualitative acceptance criteria for biocompatibility, sterility, and performance are not detailed. For instance, what specific tests were performed for "biocompatibility" (e.g., cytotoxicity, irritation, sensitization), what were their acceptance limits, and what were the exact results? Similarly for sterility (e.g., SAL of 10^-6) and performance (e.g., balloon inflation pressure, catheter maneuverability, membrane repositioning effectiveness).

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, but given the nature of the device (fetal membrane manipulator), these tests are likely conducted in a lab setting or in animal models, not human clinical trials for this type of 510(k). The document mentions "performance testing" which usually refers to bench testing.

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

• Number of Experts: Not applicable, as this is primarily a device performance and safety evaluation (biocompatibility, sterility, mechanical performance) rather than an interpretative diagnostic device requiring expert ground truth in the traditional sense.
• Qualifications of Experts: Not applicable for the reasons above.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The tests mentioned (biocompatibility, sterility, performance) would typically involve objective measurements against predefined standards rather than consensus-based adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done: No, this type of study is typically for evaluating the effectiveness of diagnostic devices or AI algorithms where human interpretation is involved. This device is an instrument for a surgical procedure.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done: Not applicable. This is a medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the context of expert-derived ground truth. For the reported tests, the "ground truth" would be established scientific standards and methods for assessing biocompatibility (e.g., ISO 10993 series), sterility (e.g., USP or ISO 11137/17665), and engineering performance (e.g., specified mechanical properties, leak tests, etc.).

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning context. Its development and validation are based on engineering principles, materials science, and established medical device testing protocols.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document does state regarding acceptance criteria and studies:

The 510(k) summary states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration established and recognized international standards. Testing results were well within the acceptance criteria. Testing data and information is included in this submission."

This indicates that standard, established protocols were followed for these critical safety and performance aspects. However, the specific details of these protocols, the exact acceptance criteria, and the measured results are not provided in the publicly available summary. Such details would typically be contained within the full 510(k) submission document to the FDA.

Ask a specific question about this device

Used to obtain endometrial cytological and histological samples.

The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.

The provided text describes the 510(k) submission for the Tao Brush™ I.U.M.C. Endometrial Sampler. However, it does not contain specific details about acceptance criteria, a dedicated study proving device performance against such criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness studies. The submission states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission," but the actual data and methodology are not included in the provided snippets.

Therefore, the following information is based only on what is explicitly stated or can be inferred from the provided text. Many fields will be marked as "Not provided in the text."

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text does not explicitly define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance against such criteria for the Tao Brush™ I.U.M.C. Endometrial Sampler. It generally states that "performance testing" was conducted.

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided. The text only states that testing was performed, but doesn't mention the country of origin of data or whether it was 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 provided.
• Qualifications of Experts: Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not provided.

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 device is an endometrial sampler, a physical medical device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Standalone Study: Not applicable. This is a physical sampling device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated for performance testing. Given the device's purpose ("used to obtain endometrial cytological and histological samples"), the ground truth for evaluating sampling efficacy would typically involve laboratory analysis (e.g., pathology reports) of the procured samples, but this is an inference, not directly stated.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable. This is a physical device, not an AI algorithm.

Ask a specific question about this device

Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.

Cook Wire Guides are designed to be used during Urological procedures where use of a wire quide is warranted. The wire quides consists of a single piece of wire tightly wound into coils from tip to tip. Two additional wires are present inside the coils, one called a flat safety wire and the other a round wire. Some of the wire guides are coated with a polymer sleeve, some with PTFE, some are stainless steel, and some are hydrophilically coated. Several variations of Cook Wire Guides are available. The wire quided sterile in peel-open packages and are intended for onetime use.

The provided text describes Cook Wire Guides and their substantial equivalence to existing devices. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a study that would demonstrate meeting such criteria.

Specifically, the text mentions:

• "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards."
• "Testing data and information are included in this submission."

This indicates that such testing was done and submitted, but the actual results, the acceptance criteria used, and the details of how the studies were conducted (like sample size, ground truth establishment, expert qualifications, etc.) are not included in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given input, nor can I answer points 2 through 9 regarding study details. The information about the study design and results is simply not present in the provided 510(k) summary and FDA letter.

Ask a specific question about this device

Used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.

The INJEKT™ Filiform Injection Needle consists of a needle and an outer sheath with a filiform tip. Hash marks on the outside of the needle are used to assess proper depth of placement. The filiform tip of the needle acts as a landmark for easier access to precise injection. The needle exits the side of the device to allow precise injection and assures additional safety for the patient against inadvertent stick when the needle is retracted. The devices are provided sterile and are intended for one time use.

The provided text describes a 510(k) submission for the INJEKT™ Filiform Injection Needle but does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the performance of the device against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technology, rather than presenting a performance study with defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

1. Table of acceptance criteria and reported device performance: This information is not provided in the document. The submission states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards," but it does not detail the specific acceptance criteria or the reported performance results.

2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "performance testing" but does not specify any test set, 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: This information is not provided. No test set or ground truth establishment process is described in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided. No test set or adjudication method is 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: This information is not applicable/provided. The device is an injection needle, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable/provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided. No ground truth for performance evaluation is described.

8. The sample size for the training set: This information is not applicable/provided. The document describes a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: This information is not applicable/provided. As above, this document does not describe an AI algorithm or its training.

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence based on the device's indications for use and technology compared to existing predicate devices, rather than presenting a detailed study with specific acceptance criteria and detailed performance results.

Ask a specific question about this device

Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.

The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is a pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power. The normal wavelength is strongly absorbed by water for tissue ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the calculus causing it to crack into small enough particles to pass easily. The system is a completely enclosed transportable unit.

This submission is for a medical device (Cook® Odyssey Holmium Laser System) and focuses on substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human reader assessment. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from the provided text.

Here is the information that can be gleaned from the provided text, primarily focusing on the regulatory assertion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The submission describes a regulatory pathway based on substantial equivalence, not a clinical trial with a specific test set of patient data. The "Test Data" mentioned refers to engineering and bench testing to demonstrate compliance with standards, not clinical performance data in human subjects for statistical analysis.

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

Not applicable. This is not a study involving expert assessment of medical images or data from a test set. The "ground truth" here is the regulatory equivalence established through technical and functional comparisons to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to evaluate the impact of AI on human reader performance, which is not relevant for this device's 510(k) submission.

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

Not applicable. This device is a laser system, not an algorithm or AI product. Its performance is inherent to its physical operation, not an algorithm's standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices (VersaPulse® Power Suite, Medilas H 20, Odyssey™ 30 Holmium Laser Systems). The Cook® Odyssey Holmium Laser System's performance and design were compared to these legally marketed devices to demonstrate substantial equivalence, rather than against a specific pathology or outcomes data from a clinical trial.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI-based device and no machine learning model was developed or trained.

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

Not applicable, as no training set is mentioned.

Ask a specific question about this device

Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.

The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.

The provided text describes the 510(k) submission for the OptiLite™ Holmium Laser Fibers. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding specific acceptance criteria for device performance, the study design for such performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

The document indicates that the device's substantial equivalence is based on its similarity to existing predicate devices regarding "indications for use and technology," and that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." However, the details of these performance tests and their specific acceptance criteria are not included in the provided text.

Therefore, I can only provide information based on what is explicitly stated or can be inferred from the text. Many sections of your request will be answered with "Not provided in the text."

Acceptance Criteria and Study Details for OptiLite™ Holmium Laser Fibers

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Functionality:
   - Deliver laser energy from proximal to distal end for incision/excision, ablation, and coagulation.	"The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end." No specific quantitative metrics for energy delivery or efficacy are provided. Performance testing was done, but specific results or acceptance thresholds are not detailed.
   Biocompatibility:	"Biocompatibility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
   Sterility:	"Sterility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
   Compatibility: (with specific laser systems)	"Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared." No specific performance metrics or acceptance criteria for this compatibility are detailed.

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 in the text. The document only states that "Performance testing were performed," but no details on the sample size (e.g., number of fibers tested, number of procedures simulated), type of data, or provenance are given.

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 / Not provided in the text. This type of information is typically relevant for AI/imaging devices involving interpretive tasks. For a laser fiber, the "ground truth" would be established through engineering and biological performance standards, not expert adjudication of images. The text does not mention any expert involvement in establishing ground truth for performance testing.

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

   • Not applicable / Not provided in the text. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation. This is not relevant for the described performance testing of a laser fiber.

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 / Not provided in the text. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. The OptiLite™ Holmium Laser Fiber is a medical device for delivering laser energy, not an AI or imaging device, so such a study would not be applicable.

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

   • Not applicable / Not provided in the text. This question is also relevant for AI/algorithm-based diagnostic devices. The OptiLite™ Holmium Laser Fiber is a physical medical device. Its "standalone performance" refers to its ability to function as designed (deliver laser energy, biocompatibility, sterility) which was stated as having been tested.

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

   • Based on engineering and biological performance standards. The text indicates "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." This implies that the "ground truth" for evaluating the device's performance would be established by predefined engineering specifications (e.g., laser energy transmission efficiency, damage thresholds) and biological safety standards (e.g., cytotoxicity, irritation). No mention of expert consensus, pathology, or outcomes data for establishing the performance 'ground truth' is made.

8. The sample size for the training set

   • Not applicable / Not provided in the text. Training sets are used in machine learning and AI. This device is a physical, non-AI medical device; therefore, no training set in the AI sense would be used. The text does not mention any data sets used for "training" the device.

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

   • Not applicable / Not provided in the text. As explained above, this device does not involve a training set in the context of AI.

Ask a specific question about this device

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2.8 French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion.

The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°.

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.

The provided document is a 510(k) summary for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and the specifics of a study proving device performance in the context of AI/machine learning.

The document states: "Biocompatibility and bench performance testing was performed to demonstrate the safety and performance of the Cook® Fiber Optic bundle and the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath when used together. Testing was performed by Cook Urological, Incorporated and an independent laboratory in accordance with recognized standards. All test results were acceptable."

This indicates that some testing was done, and it met acceptance criteria, but the criteria themselves and the specific numerical results are not provided in this summary. Furthermore, this device is a traditional medical device (fiber optic bundle and access sheath), not an AI/ML-driven device. Therefore, questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies for AI improvement are not applicable to the information contained in this document.

Given the information provided, here's what can be extracted and what cannot:

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 specified.
• Data Provenance: Testing performed by Cook Urological, Incorporated and an independent laboratory. No specific country of origin or whether it was retrospective/prospective is mentioned. Given the nature of bench testing for a physical medical device, it would likely be laboratory-based rather than clinical 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 as this is not an AI/ML device requiring expert ground truth for diagnostic accuracy. Testing was for device safety and performance (e.g., physical characteristics, biocompatibility).

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

• Not applicable for the type of bench and biocompatibility testing described for this traditional medical device.

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, this is not an AI/ML device. Therefore, no MRMC study comparing human readers with/without AI assistance was performed or described.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable in the context of diagnostic AI. For physical device performance, "ground truth" would be established by validated test methods, adherence to engineering specifications, and recognized standards for biocompatibility.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

In summary, the provided 510(k) summary (K072521) for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath describes a traditional medical device. The document confirms that "Biocompatibility and bench performance testing was performed" and "All test results were acceptable," but it does not provide the specific numerical acceptance criteria or the detailed results of these tests. Many of the questions posed are relevant to AI/machine learning devices and therefore do not apply to the information available in this 510(k) submission.

Ask a specific question about this device

Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.

Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.

The provided text describes a 510(k) submission for the Sydney IVF Sperm Cryopreservation Buffer, focusing on demonstrating its substantial equivalence to a predicate device. This submission is for a medical device rather than an algorithm or AI-driven device. As such, many of the requested categories in the prompt, which are typically relevant for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not directly applicable or discussed in the provided documentation.

However, I can extract the acceptance criteria for the device's performance based on the specific tests mentioned.

Here's an analysis of the provided text in the context of your request:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified in the provided document. The text states "Sydney IVF Sperm Cryopreservation Buffer was subjected to the following tests," implying that samples of the buffer were tested, but no number of batches or units is given.
• Data Provenance: Not specified. The tests would have been performed by Cook Urological Incorporated or a contracted lab.

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 chemical buffer, not an AI or diagnostic tool where expert ground truth on data is typically established. The "ground truth" for this device is its physical and biological performance against established scientific and regulatory standards (e.g., pH limits, osmolality ranges, MEA success rates, endotoxin levels), which are determined through laboratory tests.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or between human readers and AI outputs in diagnostic imaging or similar fields. For a chemical buffer, the "adjudication" is based on the objective results of the lab tests conforming to predefined 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

• Not applicable. This is a medical device (a buffer solution), not an AI algorithm. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is not an algorithm. The "standalone performance" is the intrinsic performance of the buffer itself as demonstrated by the specified tests.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective laboratory test results that meet predefined specifications for pH, osmolality, embryo toxicity (MEA), and endotoxin levels. These specifications are based on regulatory requirements and scientific understanding for medical devices of this type. It's not based on expert consensus, pathology, or outcomes data in the sense typically applied to diagnostic algorithms.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device. The manufacturing process of the buffer is validated, and batches are tested for quality control.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

Ask a specific question about this device