Search Results

The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

The CooperSurgical Advincula Delineator™ Uterine Manipulator is a single use device, supplied sterile to the end user. It includes a cup shaped sliding colpo-pneumo occluder used to delineate the vaginal fornices, providing an anatomical marker to facilitate resection of the uterus, and a balloon to occlude the vaginal vault to maintain pneumoperitoneum during uterine resection.

The provided document is a 510(k) summary for the CooperSurgical Advincula Delineator™ Uterine Manipulator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of medical device submission. This document describes a physical medical device, not an AI or algorithmic device.

However, I can extract the relevant performance data and conclusions presented in the document based on the provided text.

Here's a breakdown of the information that is available in the document, formatted as requested where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would for an AI algorithm (e.g., "sensitivity must be > 90%"). Instead, performance assessments were conducted to ensure the device performs comparably to its predicate and is safe and effective. The "acceptance" is implied by demonstrating substantial equivalence.

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

• Sample Size: Not specified in the 510(k) summary. These would typically be engineering bench tests involving a certain number of manufactured units, not patient data.
• Data Provenance: Not applicable as this relates to bench testing of a physical device, not patient data or geographical origin of data.
• Retrospective/Prospective: Not applicable.

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. This is a physical device, not an AI or image-based diagnostic tool requiring expert ground truth for performance evaluation of an algorithm. "Ground truth" for this device would be established by engineering specifications and physical measurements.

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

• Not Applicable. This relates to clinical interpretations, not bench testing of a physical 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

• Not Applicable. This is not an AI-assisted device or diagnostic tool.

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

• Not Applicable. This is not an AI or algorithmic device.

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

• Not Applicable in the traditional sense. The "ground truth" for this device's performance would be derived from engineering specifications, material properties testing, and comparison to the predicate device's established performance through bench testing (e.g., measuring actual burst volume, tensile strength, confirming no leakage).

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable. This is not an AI or machine learning device.

Ask a specific question about this device

The Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.

The Adapter Drape for the Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.

The Cooper Surgical ALLY Uterine Positioning System™ (UPS) consists of a single multisegmented, articulated Arm that attaches to a standard OR bed rail and a separate, sterile distal adapter to accommodate a uterine manipulator. When unlocked, the articulation of the Arm allows the attached manipulator to be positioned by the user. The Arm is then locked in the desired position by depressing a foot pedal, activating a linear actuator which applies tension to an internal cable, drawing the segments together and locking the Arm.

The segmented design of the Arm allows lateral/medial movement from a single point, allowing the System to be attached to one side of the OR table.

The ALLY Uterine Positioning System™ (UPS) is not intended for patient contact. The Adapter Drape for the ALL Y Uterine Positioning System™ (UPS) is provided sterile (sterilized by ethylene oxide).

The ALLY UPS Adapter Drape secures either the Cooper Surgical RUMI II Uterine Manipulator Handle or the Advincula Arch Uterine Manipulator Handle to the distal end of the ALLY Arm. After attaching the Adapter, the sterile Drape is deployed to cover the non-sterile ALLY UPS Arm, maintaining the sterile field and protecting the Arm from contamination during the procedure.

The provided document is a 510(k) premarket notification for the Cooper Surgical ALLY Uterine Positioning System™ (UPS) and its Adapter Drape. It asserts that the device is substantially equivalent to a predicate device, the Intuitive Surgical "Probe Holder System, K071405. The document describes performance data and testing conducted, but it does not describe a clinical study with human patients to prove the device meets acceptance criteria in the context of clinical outcomes or diagnostic accuracy. Instead, the performance data focuses on mechanical and functional aspects relevant to substantial equivalence determination for a surgical tool's positioning system.

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

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

Note: The document primarily outlines the types of testing performed rather than specific quantitative acceptance criteria or exact performance values. The "Determination" column in the table of "Comparison of Technological Characteristics with the Predicate Device" consistently states "Substantially Equivalent," implying that the device's performance in these areas was deemed comparable to the predicate.

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

The document does not explicitly state the sample sizes used for the mechanical and functional tests conducted (e.g., number of units tested for holding force, durability, etc.). It describes device testing, not a clinical study involving patients or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the context of clinical data.

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. The testing described is for the mechanical and functional performance of a surgical positioning system, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

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

This is not applicable as the document describes device safety and performance testing, not a clinical study requiring adjudication of expert interpretations.

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 was done. This device is a mechanical surgical positioning system, not an AI-powered diagnostic or assistive tool for "human readers."

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

This is not applicable. The device is a physical surgical tool, not an algorithm.

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

This is not applicable. The "ground truth" for the device's performance would be engineering specifications, physical measurements, and compliance with standards, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."

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

This is not applicable, as there is no "training set."

Ask a specific question about this device

The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.

The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.

The provided text describes the Cooper Surgical Leisegang Colposcope System, a medical device for magnified viewing of tissues. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/CADe device.

Therefore, the information typically requested for AI/CADe devices (such as clinical study sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable or available in this document. The "Performance Data" section specifically states "Non-clinical testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates."

The acceptance criteria here are implicitly met if the device's technical specifications and non-clinical performance are deemed substantially equivalent to the predicate devices, and if it complies with relevant electrical safety and electromagnetic compatibility standards.

Here's a breakdown based on the information provided, recognizing that it pertains to a traditional medical device and not an AI/CADe system:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not applicable. This is a traditional optical device, not an AI/CADe system. Testing involved non-clinical attribute comparisons and compliance with electrical/EMC standards. No patient data or test set in the AI/CADe sense was utilized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert medical review was established for the technical performance of this optical colposcope for the purpose of regulatory submission. The document refers to "non-clinical testing."

4. Adjudication method for the test set:
Not applicable. No expert adjudication process was described for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a colposcope, an optical instrument for direct viewing, not an AI or CADe system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:
For the technical specifications, the "ground truth" was derived from measurements against engineering and performance standards (e.g., USAG Chart NBS 1963A for resolution, direct measurements for depth of field, distortion, and illumination properties). For regulatory purposes, the primary "ground truth" for substantial equivalence was the performance and characteristics of the predicate devices.

8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning system.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

Ask a specific question about this device

Ten-Year Fracture Risk Option: The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporotic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

SIRI Table Option: The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.

Here's a breakdown of the acceptance criteria and study information for the "Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers," based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Ten-Year Fracture Risk: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned, but "Norland customers" are referenced for the broader testing. The data is retrospective as it refers to "previously acquired data."
   • SIRI Table Option: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned. The data is retrospective.

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

   • No expert "ground truth" establishment is described for the test set. For the Ten-Year Fracture Risk option, the comparison was made against the "charts on the FRAX website" and the "FRAX publication." For the SIRI Table Option, the verification was against the "proper chart" and the "SIRI UWE % Fat value." The comparison for the Ten-Year Fracture Risk chart values was done "by a person different from the one who entered the data," suggesting an internal verification process rather than external expert consensus.

3. Adjudication method for the test set:

   • Adjudication methods like 2+1 or 3+1 are not mentioned. The testing described focuses on direct comparison and verification against established standards (FRAX website/publication, industry-standard body fat charts). For the Ten-Year Fracture Risk chart values, there was a double-check by a different person.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for either of these options to establish safety or effectiveness, because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results."

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

   • Yes, the performance described is standalone. The software options "use presently provided scan results and related industry standards to provide additional information" and "do not affect the technology... No physical changes are required and the scanning and analysis functions are not impacted." The "proper operation of both options with real patient data was tested" which describes the standalone algorithm's output.

6. The type of ground truth used:

   • Ten-Year Fracture Risk: The ground truth used was the World Health Organization (WHO) Fracture Risk Assessment algorithm (FRAX) accessible via its website charts and publication.
   • SIRI Table Option: The ground truth used was industry-standard Body Fat Charts developed by Tanita from the work by D. Galligher, and classifications from the National Institute of Health (National Heart, Lung, and Blood Institute) relating BMI to % body fat.

7. The sample size for the training set:

   • The document does not mention a separate "training set" for the device. The device is a software option that applies existing algorithms (FRAX, Tanita/Galligher body fat charts) to pre-existing DXA scan results. Hence, the algorithms themselves would have been developed and "trained" on their respective datasets by WHO/FRAX and Tanita/Galligher/NIH over time, not by Norland for this specific device submission.

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

   • As there's no training set for this specific device, the ground truth for the underlying FRAX algorithm and body fat charts was established externally by the World Health Organization (WHO), Tanita Corporation, and the National Institute of Health (National Heart, Lung, and Blood Institute) respectively, based on their research and epidemiological studies. The document does not describe their ground truth establishment methods.

Ask a specific question about this device

The sterile singe-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded.

Assisted Reproduction Catheters / Stylets are single-use sterile devices provided for use with CooperSurgical Assisted Reproduction Catheters, should passage through the cervix be impeded. The devices have an overall length of 23cm and 18cm and consist of a malleable inner stylet and a detachable rigid outer sheath, which is attached to the flexible inner stylet by a male/female Luer Lock adaptor. When the outer sheath Luer is attached to the hub of the stylet, the inner malleable stylet forms a smooth radius at the outer sheath. The outer sheath has a series of 1cm graduations at the distal end. The stainless steel stylet is encapsulated in Teflon (FEP).

The CooperSurgical Malleable Stylet, as described in the 510(k) Premarket Notification K023382, is a single-use sterile device intended for use with CooperSurgical Assisted Reproduction Catheters during in-vitro fertilization procedures when passage through the cervix is impeded.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a Class II medical device, the acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device. This typically means showing that the new device has the same intended use, technological characteristics, and performance as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.

2. Sample Size for Test Set and Data Provenance

For this 510(k) submission, the "test set" does not refer to a clinical study involving a patient cohort or a typical algorithm validation set. Instead, the "testing" involves bench testing to confirm material properties and mechanical performance.

• Sample Size: Not explicitly stated as a number of stylets tested, but refers to testing conducted on device materials and luer fittings. It's implied that sufficient samples were tested to demonstrate compliance with the referenced ISO standards.
• Data Provenance: The biocompatibility and luer taper testing would have been conducted in a laboratory setting, likely by the manufacturer or a contract testing organization. This is not clinical data (e.g., from a specific country or retrospective/prospective).

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

Not applicable. This type of regulatory submission for a simple medical device like a stylet does not involve human experts establishing ground truth for performance in the way an AI diagnostic algorithm would. The "ground truth" here is objective physical and chemical properties confirmed by standardized laboratory tests (e.g., ISO standards for biocompatibility and luer fit).

4. Adjudication Method for the Test Set

Not applicable. As described above, no expert adjudication process is relevant for bench testing of material properties and mechanical dimensions.

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

No. An MRMC study is typically conducted for diagnostic imaging devices or AI algorithms where human interpretation is involved. This device is a surgical accessory, and its effectiveness is assessed through its physical and mechanical properties for its intended use, not through human reading of images or data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No. This device is not an algorithm or software. It is a physical medical instrument. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's compliance is based on:

• Objective Technical Standards: Compliance with ISO 10993-1 (Biocompatibility) and ISO 594-1 1986 (Conical fittings with a 6% luer taper).
• Material Specifications: Verifying that the device's components are made from the specified and appropriate medical-grade materials.
• Dimensional Measurements: Confirming the physical dimensions (length, luer size) meet design specifications and are comparable to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus.

The CooperSurgical Trial Transfer catheters are single-use sterile, disposable, flexible catheters with a round smooth distal end. The tip has a blind/closed end. The device has an overall length of either 18cm or 23cm including a polypropylene Luer Lock Adaptor that is affixed at its proximal end. The inner catheter is a clear tube with a 1.8mm outer diameter and a 0.8mm inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catherer insertion to the uters during embryo placement. The distal 0.1cm length of the outer sheath possesses a gradual taper and is shorter than the inner catheter leaving the distal 5cm of the inner catheter exposed. The proximal circumferences of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock Adaptor. Five black (ink) graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advanced into the cervix. This facilitates catheter positioning and placement during embryo replacement with an assisted reproduction catheter.

This document describes the 510(k) premarket notification for the CooperSurgical Trial Transfer Catheter. However, it does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding diagnostic accuracy, sensitivity, or specificity.

The document indicates that the device has undergone biocompatibility testing and complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements. It also states that the device is substantially equivalent to a predicate device (Wallace Trial Transfer Catheter K990348) based on having the same indications for use, material composition, sterilization method, and working dimensions, with minor differences in luer size and packaging.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that information is not present in the provided text. The submission focuses on substantial equivalence to an existing predicate device rather than presenting a performance study with defined acceptance criteria for diagnostic accuracy or similar metrics.

Here's what I can extract based on the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. The submission focuses on substantial equivalence based on design, materials, and existing standards, rather than a clinical performance study with a distinct "test set" in the context of diagnostic accuracy.
• The biocompatibility testing and luer taper compliance would have involved laboratory testing of samples, but the specific sample sizes for these tests are not mentioned.

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

• Not applicable / Not provided. This type of information is relevant for studies assessing diagnostic or clinical performance against a "ground truth" established by experts (e.g., radiologists, pathologists). This submission is for a medical device (catheter) based on substantial equivalence, and not a diagnostic tool requiring expert ground truth for a test set.

4. Adjudication method for the test set:

• Not applicable / Not provided. See point 3.

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 a submission for a physical medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

• No. This is a physical medical device, not an algorithm or AI.

7. The type of ground truth used:

• For biocompatibility: In vitro and in vivo biological response criteria as defined by ISO 10993-1.
• For luer taper conformity: Engineering specifications and measurements against ISO 594-1 standards.
• For substantial equivalence: Comparison to the specifications, materials, and intended use of the legally marketed predicate device (Wallace Trial Transfer Catheter K990348).
• There is no clinical "ground truth" (e.g., pathology, outcomes data, expert consensus) mentioned for evaluating the catheter's intended use ("assessing advancement through the cervical canal and positioning of the uterus"), as the submission relies on substantial equivalence to a device already on the market.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.

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

• Not applicable / Not provided. See point 8.

Ask a specific question about this device

The sterile singe-use catheter is intended for introducing washed spermatozoa into the uterine cavity.

The Intrauterine Insemination Catheter is a singe-use, sterile, disposable device for use in intrauterine insemination. The catheter has two opposing smooth side eyes and a rounded, smooth, closed distal tip. The device has an overall length of 18cm and consists of a flexible end inner catheter and a detachable outer sheath, which is attached to the inner catheter by a Luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath Luer is attached to the catheter, the inner catheter protrades from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end. The device is identified as AR-IUI.

This 510(k) summary describes a medical device, the CooperSurgical Intrauterine Insemination Catheter, and its substantial equivalence to a predicate device. It does not contain the kind of performance data that would typically be described with acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.

The information provided focuses on material composition, intended use, and general safety/effectiveness of a physical medical device compared to an existing one. There is no mention of an algorithm, AI, or any performance metrics like sensitivity, specificity, or accuracy that would be associated with such a system.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• "The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements." This indicates testing related to material safety and mechanical fit, not an algorithm's performance.
• "CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and has the same working dimensions." This is the core argument for its approval, not a performance study as you've described.

In summary, this document is for a physical medical device (catheter), not an AI/algorithm-based diagnostic or assistive device that would have the type of performance criteria and studies you are asking about.

Ask a specific question about this device

The sterile single-use device is to be used for the introduction of embryo(s) the uterine cavity during assisted reproductive procedures.

The subject devices are single-use, sterile, disposable, flexible catheters with rounded smooth distal ends, provided for the introduction of embryos into the uterine cavity during in vitro fertilization or Embryo Transfer procedures. The subject devices are available in working lengths of 18cm including Luer Lock adaptors that are affixed at their proximal ends. The inner catheter is a clear tube with a 1.8mm outer and a 0.8mm inner diameter. The inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catheter insertion to the uterus during embryo placement. The distal of the outer sheath possesses a gradual taper and is shorter than the inner catheter. Jeaving the distal 5cm of the inner catheter exposed. The proximal circumference of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock adaptor. Five black graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advancement into the cervix.

The provided 510(k) summary for the CooperSurgical Embryo Transfer Catheter (K023379) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/software performance studies.

This 510(k) is for a physical medical device (catheter), and the "performance data" section focuses on physical and material properties rather than diagnostic performance or efficacy for medical image analysis.

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance for an AI/software device, nor can I answer the questions related to sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

However, based on the information provided, I can infer the types of "acceptance criteria" and "studies" relevant to this specific device:

Types of "Acceptance Criteria" and "Studies" Applicable to this Device (Based on the 510(k) Summary):

The acceptance criteria for this physical medical device are related to its material properties, dimensions, and manufacturing processes to ensure safety and equivalence to a predicate device. The "studies" are tests conducted to demonstrate these properties.

Here's how aspects of the request align with the provided document for this physical device:

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

   • Acceptance Criteria (Implied from the document):

     • Biocompatibility (equivalent to ISO 10993-1)
     • Conical fittings comply with ISO 594-1 1986 (6% luer taper)
     • Sterility (SAL 10^-6) via validated Ethylene Oxide cycle
     • Mechanical integrity (e.g., sufficient stiffness for AR-ET23F, flexible with rounded smooth distal ends)
     • Dimensional specifications (working lengths, inner/outer diameters, luer dimensions)
     • Material composition identical to stated components
     • Packaging integrity

   • Reported Device Performance (as stated):

     • "The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements."
     • "The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements."
     • "The subject devices will be sterilized using validated Ethylene Oxide cycle affording an SAL 10^-6 to sterility level."
     • The device characteristics (materials, dimensions) are listed as designed.

2. Sample size used for the test set and the data provenance: This is not applicable. The "tests" mentioned are for physical device properties (biocompatibility, luer taper, sterility), not for evaluating diagnostic or algorithmic performance with a "test set" of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is based on established engineering standards and material science, not clinical expert consensus on a test set.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical embryo transfer catheter. MRMC studies are for assessing diagnostic performance of imaging systems or AI algorithms.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used: For this device, the "ground truth" for compliance would be established through:

   • Laboratory testing against ISO standards (e.g., for biocompatibility, luer taper).
   • Chemical/material analysis to verify stated composition.
   • Physical measurements to verify dimensions.
   • Microbiological testing for sterility.

8. The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) for the CooperSurgical Embryo Transfer Catheter (K023379) demonstrates substantial equivalence through adherence to existing standards for physical devices and material compatibility, not through clinical performance studies against a 'ground truth' as one would expect for an AI/software device.

Ask a specific question about this device