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FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.

Here's a breakdown of the acceptance criteria and the studies mentioned for the FemVue MINI Saline-Air Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that "all predetermined acceptance criteria were met" for various tests. Therefore, the table below is constructed by inferring the acceptance criteria from the type of test conducted.

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

The document does not specify the sample sizes used for the individual bench performance tests. It only states that these tests were conducted. It also does not explicitly state the data provenance (e.g., country of origin) or if the studies were retrospective or prospective, though bench testing is inherently prospective.

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

This information is not provided in the document. The tests described are primarily physical, chemical, and functional bench tests, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench tests, it's unlikely a formal adjudication method (like 2+1, 3+1) would be applicable. The tests likely have objective pass/fail criteria.

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. The document describes non-clinical performance data for a device, not a diagnostic algorithm that would typically require such a study to assess human reader improvement with AI assistance.

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

No, a standalone performance study (algorithm only) was not done. This device is a manual instrument, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance studies described, the "ground truth" refers to established engineering standards, material specifications, and functional requirements for a medical device. This is determined by the specific ASTM and ISO standards cited (e.g., ISO 11135 for sterility, ISO 10993 for biocompatibility, ASTM F1980-16 for accelerated aging). The concept of expert consensus, pathology, or outcomes data as ground truth is not applicable to these types of engineering and functional tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a hardware product, not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.

The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.

This document is an FDA 510(k) summary for the "RELIEEV" Uterine Manipulator Injector. It describes the device and claims substantial equivalence to a predicate device, the Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980).

Based on the provided text, the device in question is a medical instrument, not an AI/software device. Therefore, the questions related to AI/software performance, ground truth, human readers, and training/test sets are not applicable to this document.

The acceptance criteria and study proving the device meets them are related to the physical and biological safety and performance of the Uterine Manipulator Injector, rather than an AI algorithm.

Here's the information extracted from the document, tailored to the type of device described:

Acceptance Criteria and Device Performance for "RELIEEV" Uterine Manipulator Injector

This device is a physical medical instrument, and its performance evaluation focuses on its physical characteristics, sterility, biocompatibility, and mechanical integrity, comparing it to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details various tests performed to ensure the device meets safety and performance standards for a physical medical device. The "acceptance criteria" are implied by the successful completion of these tests per the referenced standards and the statement that "all predetermined acceptance criteria were met."

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

The document does not explicitly state the sample sizes for the various tests. It refers to established testing standards (e.g., ISO, ASTM, USP), which would specify appropriate sample sizes for each test type. The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer (LI Medical Corporation LTD.) to support regulatory submission. This is a prospective assessment of newly manufactured devices under controlled conditions.

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

This concept is not applicable to the assessment of a physical medical device like a uterine manipulator. "Ground truth" in this context refers to the defined acceptable parameters for physical and biological performance, which are established by international standards and regulatory guidelines, not by individual experts evaluating images or clinical data.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. Performance is judged against specified engineering, material, and biological safety standards, not through adjudication of expert opinions.

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, as this is not an AI/software device.

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

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements for medical device safety and efficacy. This includes:

• Physical and mechanical properties (e.g., dimensions, tensile strength, inflation capabilities).
• Sterility assurance (e.g., EtO residuals).
• Biocompatibility (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
• Packaging integrity.

These are quantitative metrics or pass/fail criteria derived from validated test methods.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/software device. There is no "training set" in the context of a physical medical device's performance validation; rather, there are samples tested according to predefined standards.

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

Not applicable, as this is not an AI/software device.

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FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.

The provided text is a 510(k) summary for the FemChec Controlled Saline-Air Device (FCD-250), which is a medical device and not an AI or software device. Therefore, the questions related to AI/algorithm performance, training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data for a physical medical device.

However, I can extract the acceptance criteria and a summary of the studies performed from the provided text for the FemChec device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the studies conducted are non-clinical bench performance and material compatibility studies for a physical device, not a performance study involving a test set of data points or images.

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

This information is not applicable. Ground truth establishment by experts is relevant for AI/software devices requiring interpretation of data (e.g., medical images), which is not the case for this physical medical device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies where multiple readers/experts assess cases, which is not applicable to the non-clinical studies for this physical device.

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. The document describes non-clinical performance studies for a physical device.

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 instrument, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI/software performance. For the described bench tests, the "ground truth" would be established by the specifications and standards (e.g., flow rates, material properties, sterility levels) defined in the test protocols themselves, which are based on recognized international and ASTM standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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

This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

The ELLAVI UBT device, intended for temporary control or reduction of postpartum uterine bleeding, underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Bakri Postpartum Balloon. The provided documentation primarily focuses on mechanical, biocompatibility, sterilization, and shelf-life testing. No clinical study data is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details non-clinical performance data (mechanical, biocompatibility, sterilization, and shelf-life testing). It does not describe a "test set" in the context of clinical or image-based studies with human subjects. Therefore, information about sample size, country of origin, or retrospective/prospective nature of such a test set is not applicable from this document. The tests performed are laboratory-based evaluations of the device's physical and material properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document describes non-clinical engineering and material science tests. "Ground truth" in the context of expert consensus for clinical diagnosis is not relevant to these types of tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method. The reported performance is based on direct measurements and observations from laboratory testing.

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

No MRMC comparative effectiveness study was mentioned or conducted, as this documentation pertains to non-clinical testing for substantial equivalence of a medical device.

6. Standalone Performance Study

The documented studies are standalone in the sense that they evaluate the device itself (its mechanical properties, biocompatibility, etc.) without human interaction as part of the performance evaluation. However, this is not a "standalone performance" in the context of algorithm-only performance for a diagnostic device, as the ELLAVI UBT is a physical medical instrument.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on engineering specifications, material science standards, and established laboratory testing protocols. For instance:

• Mechanical Testing: Physical measurements against design specifications, established parameters (e.g., pressure ranges, fill volumes, time limits).
• Biocompatibility Testing: Compliance with ISO 10993 series standards, where reactivity or toxicity is evaluated against established biological models.
• Sterilization and Shelf-Life: Compliance with ISO 11135 and ASTM standards for sterility assurance levels, aging profiles, and package integrity.

8. Sample Size for the Training Set

Not applicable. The ELLAVI UBT is a physical medical device. It does not involve machine learning algorithms or a "training set" in the context of artificial intelligence.

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

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

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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.

The Apyx device is a single use device which is supplied sterile.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical or performance study with specific metrics like sensitivity, specificity, or AUC, as these would be associated with diagnostic or AI-powered devices.

However, based on the information provided, here's a breakdown of what can be extracted regarding performance and testing:

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

The document mentions various tests conducted, generally implying that the device met the requirements of these tests to demonstrate safety and effectiveness. Since specific numerical acceptance criteria (e.g., "pull-out strength > X N") and the exact reported performance values are not explicitly stated, I will infer the acceptance as "Met requirements" based on the conclusion of substantial equivalence.

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

• Sample size for test set: The "Cadaver Testing" section does not specify the number of cadavers or the number of anchors tested. It uses general phrasing like "users," "all anchor delivery and retrieval procedures," and "All anchors."
• Data provenance: Not explicitly stated, but cadaver testing implies a controlled laboratory environment. The country of origin of the data is not mentioned. It is prospective testing carried out for regulatory submission.

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. The cadaver testing describes the actions of "users" (implying medical professionals) who delivered and retrieved anchors, but doesn't mention independent expert assessment or ground truth establishment in a formalized way for outcomes like accuracy or safety observed during the testing. The "ground truth" here is the observed outcome of the procedure itself (e.g., successful placement, no damage).

4. Adjudication method for the test set

• Not applicable/Not described. The cadaver testing describes qualitative observations of successful delivery, retrieval, and proper fixation. There's no mention of an adjudication process for resolving disagreements between multiple observers, as might be seen in diagnostic studies.

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 device is a surgical instrument (fixation device), not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant or discussed.

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

• No. This device is a manual instrument for surgical use, not an algorithm.

7. The type of ground truth used

• For the cadaver testing, the ground truth was the direct observation of the physical outcome and success of the procedure (e.g., "anchors were accurately delivered," "no damage observed," "properly fixed"). This is akin to direct experimental observation and physical verification rather than consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set

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

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

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

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The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.

The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed.

The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.

The provided text is a 510(k) summary for the "wee BELL Circumcision Device" and describes its characteristics, intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving performance against such criteria for a medical device that would involve a test set, ground truth, expert opinions, or MRMC studies.

The document states:

• "Nonclinical functional performance testing was performed on the subject device and included functional testing (visual inspection, tensile testing and smoothness testing), packaging testing per ASTM F88-21, ASTM D4169-22 and ISO 11607, sterilization per ISO 11135:2014 and biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. Additionally, material mediated pyrogenicity was conducted."

This indicates engineering and material-based tests were performed to ensure the device's physical properties, sterility, and biocompatibility, but not clinical performance benchmarks in terms of diagnostic accuracy or effectiveness measured against a ground truth developed by experts. The device is a "manual instrument," not an AI/ML-driven diagnostic device, which is typically what the questions (sample size for test set, ground truth, experts, MRMC, etc.) pertain to.

Therefore, I cannot provide the requested table and information based on the provided text, as the type of evaluation described is foundational for a medical device's physical integrity and safety, rather than a clinical performance study with statistical endpoints related to diagnostic accuracy or efficacy improvement with human-in-the-loop.

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The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.

Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.

The provided text describes a 510(k) premarket notification for the Carevix™ Suction Cervical Stabilizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report for a novel medical device, especially an AI/ML-driven one.

Therefore, many of the requested details, particularly those pertaining to AI/ML device performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details), are not present in the provided text, as this is a traditional medical device submission.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the device was evaluated against its design and user specifications, and that "All the results were in accordance with the test acceptance criteria." However, it does not provide a table of specific quantitative acceptance criteria or the reported device performance metrics for different parameters (e.g., specific force applied, vacuum pressure achieved, or a pass/fail rate for a clinical outcome).

Instead, it lists the types of tests performed and their general outcomes:

Missing Information (as per the provided text):

• Sample size used for the test set and the data provenance: Not mentioned. The testing appears to be primarily bench testing (biocompatibility, sterilization, performance) rather than clinical studies with patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Ground truth as typically understood for AI/ML devices (e.g., disease presence) is not relevant to this device's testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device nor a diagnostic imaging device that would typically involve human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is not an AI/ML algorithm.
• The type of ground truth used: For biocompatibility, the ground truth is established by standardized lab tests (e.g., cell viability, skin irritation). For performance, the ground truth is the device's design specifications. No "expert consensus" or "pathology" ground truth is mentioned.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of what the document focuses on instead:

The document outlines a 510(k) submission for a modified medical device. The primary goal is to demonstrate "substantial equivalence" to a previously cleared predicate device (ASPIVIX v1.1 Cervical Suction Tenaculum, K203820). This is achieved by:

• Comparing Indications for Use: Stating they are the same ("to snare, grasp, hold and manipulate cervical tissue").
• Comparing Technological Characteristics: Identifying both similarities and differences (e.g., changes in rod length, inner diameter, trigger mechanism, vacuum generation, and two-piece vs. one-piece design).
• Providing Safety and Performance Data for the Modifications: This includes:
  • Biocompatibility testing: Performed in accordance with ISO 10993-1, 10993-5, 10993-10, and ISO 14971:2019. Tests confirmed non-cytotoxic, non-sensitizing, and non-irritating results.
  • Sterilization validation: Performed via e-beam in accordance with ANSI/AAMI/ISO 11137-2:2013.
  • Performance and Safety testing: Conducted according to protocols used for the predicate device, with all results meeting acceptance criteria. The document states that newly identified risks (related to assembly) do not raise new questions of safety or effectiveness because they are identifiable before patient use.
• Conclusion: The testing results support the determination of substantial equivalence, meaning the modified device is considered as safe and effective as the predicate device.

In essence, this is a clearance for a physical medical instrument based on engineering and biological testing, not an AI/ML software device.

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The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes.

When used for HSG. the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency.

The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.

The Rejoni Intrauterine Catheter is a sterile, single-lumen uterine catheter intended for delivering contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. It can also be used for evaluation of tubal patency during HSG.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were used for tensile testing, biocompatibility, etc.). However, it indicates these were pre-clinical tests (lab-based) rather than clinical studies with patient data. Therefore, data provenance such as country of origin of data or retrospective/prospective characteristics is not applicable in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The described studies are pre-clinical performance and safety tests (mechanical, biocompatibility, sterility, shelf life) rather than studies that require expert-established ground truth on diagnostic accuracy, for example. The "ground truth" for these tests is defined by established industry standards (ISO, ASTM) and the device's own design specifications.

4. Adjudication Method:

Not applicable. As noted above, these are pre-clinical tests following defined protocols and standards, not studies requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical catheter, not an AI-assisted diagnostic tool requiring evaluation of human reader improvement.

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

No, a standalone (algorithm only) study was not done. This device is a manual instrument and does not involve an algorithm.

7. Type of Ground Truth Used:

The ground truth for these tests is implicitly or explicitly defined by:

• Design Specifications: For mechanical and functional performance, the device's own engineering and design requirements serve as the ground truth.
• International Standards (ISO, ASTM): For biocompatibility, sterility, and packaging/shelf life, the ground truth is established by the specified ISO and ASTM standards and their acceptance criteria (e.g., non-cytotoxic, SAL of 10$^{-6}$).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning 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 device.

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The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.

The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury.
The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.

The provided text describes a 510(k) premarket notification for a medical device called the Konig Mogen Clamp. This submission is for demonstrating substantial equivalence to a predicate device, not for establishing clinical efficacy or safety from scratch through the rigorous testing typically performed for novel devices or AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested about acceptance criteria, study details (sample size, data provenance, expert ground truthing, MRMC studies, standalone performance, training set details) that would be relevant for an AI/SaMD device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for physical performance, biocompatibility, and cleaning/sterilization validation, as detailed in the "Summary of Non-Clinical Testing" section.

Here's a breakdown based on the provided document, highlighting why most of the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of non-clinical tests. The "Acceptance Criteria" for this type of device are typically met by passing standard international and ASTM (American Society for Testing and Materials) tests for surgical instruments. The "Reported Device Performance" is stated as "Test articles met the acceptance criteria" and "The Konig Mogen Clamp was non-toxic," and "No growth at the end of the incubation period." Specific numerical results or detailed acceptance ranges are not provided in this summary.

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

This document describes non-clinical bench testing for a physical surgical instrument. The "test set" would refer to the number of physical clamps subjected to the various physical, chemical, and sterilization tests. The document does not specify the exact number of units tested.

• Sample Size: Not specified for non-clinical tests. Medical device bench testing for performance and cleaning/sterilization typically involves a representative sample size of devices, often in the range of 3-30 units, depending on the test and statistical considerations.
• Data Provenance: Not applicable in the sense of patient data. The tests are performed on manufactured devices.

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

Not applicable. "Ground truth" in the context of this device's testing refers to objective measurements against engineering standards (e.g., material composition, hardness, successful sterilization, resistance to corrosion) rather than expert interpretation of patient data. These tests are performed by technicians or engineers.

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

Not applicable. This refers to establishing consensus among human readers for diagnostic tasks, which is not relevant for this type of device's non-clinical testing.

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 type of study is relevant for AI or diagnostic imaging devices that assist human readers. The Konig Mogen Clamp is a manual surgical instrument.

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

Not applicable. This refers to the performance of an AI algorithm, not a manual surgical instrument.

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

The "ground truth" for this device's non-clinical testing is based on:

• Pre-defined engineering specifications and ASTM/ISO standard requirements (e.g., chemical composition, hardness values, corrosion resistance, maximum opening, sterilization success).
• Objective measurements obtained through laboratory testing (e.g., spectral analysis for material, physical force measurements, microbial growth assays).

8. The sample size for the training set:

Not applicable. This device is a mechanical instrument, not an AI/machine learning model that requires a training set.

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

Not applicable, for the same reason as #8.

In summary: The provided FDA 510(k) clearance document details the substantial equivalence of a manual surgical instrument and, therefore, focuses on non-clinical performance, safety (biocompatibility), and sterilization validation against established industry standards. It does not involve the types of clinical studies, AI performance metrics, or ground truth establishment relevant for an AI/SaMD device that the questions are implicitly structured to address.

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

The ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.

The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.

The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ALLY II UPS™ (Uterine Positioning System). This type of document is for medical devices, not AI/ML algorithms. Therefore, the questions related to AI/ML specific aspects like training data, ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to this submission.

The acceptance criteria and performance data described in this document relate to the physical and mechanical performance of the revamped medical device compared to its predicate.

Here's an analysis based on the provided text, focusing on the device's acceptance criteria and proven performance:

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

The document doesn't provide a direct table of acceptance criteria with corresponding performance values for the ALLY II UPS™. Instead, it broadly states that "The ALLY II UPS met the pre-determined acceptance criteria for each intended output." It lists the types of tests performed.

Implied Acceptance Criteria and Performance (based on Section VII. Performance Data):

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

• Sample Size: The document does not specify the sample size for any of the tests (Durability, Holding force, Range of motion, Link Soak, Foot Pedal Cable Retention).
• Data Provenance: The data provenance is internal testing performed by CooperSurgical, Inc. It is a prospective test in the sense that newly designed units of the ALLY II UPS™ were manufactured and then tested to demonstrate their performance. The country of origin for the testing is not explicitly stated but is implied to be within the company's operational context (likely US, given the FDA submission).

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

This question is not applicable as this is a mechanical device, not an AI/ML system that requires expert interpretation for ground truth. The "ground truth" for this device would be defined by engineering specifications and objective measurements (e.g., force in Newtons, angles in degrees, material integrity).

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

Not applicable for this type of device. Adjudication methods are typically used in clinical studies or for establishing ground truth from human interpretations (e.g., radiology reads). The performance of this device is assessed through engineering and mechanical testing against 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 device is a mechanical uterine positioning system, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

Not applicable. This is a purely mechanical device; there is no AI algorithm to test for "standalone" performance.

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

The "ground truth" in this context is defined by engineering specifications, mechanical measurements, and compliance with recognized standards. For example:

• Holding Force: Measured in units of force (e.g., Newtons or pounds) against a specified minimum.
• Range of Motion: Measured in degrees or specific positions achievable, defined by design.
• Durability: Performance over a specified number of cycles or operating hours.
• Material Integrity: Assessed through material science tests and visual inspection post-soak/cycle.
• Electrical Safety/EMC: Compliance verified against the specified IEC standards (60601-1 and 60601-1-2).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not an AI/ML device.

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