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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 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 Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.

The Circumplast is a device composed of two components, a transparent plastic conic tube, and a linen ligature. The device is sold sterile for single use, packaged in a sterile pouch. The Circumplast is available in four (4) sizes, to accommodate size of the infant's penis. The Circumplast is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare Practitioner fixes the patient's foreskin over the inner ring and then the prepuce is tied all around, over the groove of the bell, with a tight ligature. Skin forward of the crush line is trimmed away. After the procedure, the Circumplast device remains on the patient for 7 days. The Circumplast falls off after 3 - 7 days.

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.

Based on the provided document, the device in question is the Circumplast Circumcision Device.

Here's the analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it describes various non-clinical tests conducted and their pass status, implying that the acceptance criterion for each test was to pass it.

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

• Non-Clinical Performance Data: The document does not specify the sample sizes (e.g., number of devices tested) for the Compression, Tensile Strength, Torsion, Sterilization, and Biocompatibility tests. The data provenance is also not explicitly stated in terms of country of origin for these non-clinical tests. They are presented as general lab tests performed to support substantial equivalence.
• Clinical Performance Data:
  • Sample Size: Not specified. The document only states "Two clinical studies conducted."
  • Data Provenance: England and Australia (retrospective or prospective is not specified, but typically clinical trials are 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 document describes non-clinical engineering tests and clinical studies, but it doesn't detail the process of establishing "ground truth" for a test set in the way one might for an AI/diagnostic device. For clinical studies, the "ground truth" would be derived from the patient outcomes and expert medical assessment during the study, but the specifics of how many experts were involved in evaluating these outcomes and their qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the focus is on non-clinical performance and a general statement about clinical safety and effectiveness, an explicit adjudication method for a "test set" as typically seen in diagnostic device evaluations (e.g., 2+1, 3+1 consensus) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable/provided. The device in question, the Circumplast Circumcision Device, is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed for this product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. As explained above, this device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Non-Clinical: The "ground truth" for the non-clinical tests (Compression, Tensile Strength, Torsion, Sterilization) is based on engineering standards and design specifications. For Biocompatibility, the ground truth is established by ISO 10993-1 standards.
• Clinical: The "ground truth" for the clinical studies, where safety and effectiveness were demonstrated, would be based on patient outcomes as assessed by healthcare practitioners in a clinical setting.

8. The Sample Size for the Training Set

This information is not applicable/provided. The concept of a "training set" is usually relevant for machine learning or AI models. For a physical medical device, the "training set" would arguably be the accumulation of engineering design iterations and preliminary testing, but the document doesn't provide specific sample sizes for these development stages.

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

This information is not applicable/provided for the reasons stated in point 8.

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Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The Male Circumcision Kits: RAPIDECLAMP™ is a surgical procedure purposely for circumcision which using a set of clamps that involves partial or complete removal of the foreskin (prepuce) of the penis. This device was designed technologically using molding process to replace the conventional method. It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS). Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.

The provided document describes the Male Circumcision Kits: RAPIDECLAMP™. This is a medical device, and the information focuses on its substantial equivalence to predicate devices for FDA clearance, rather than a detailed efficacy study with acceptance criteria and performance metrics in the typical sense of AI/software devices.

However, I can extract information related to the device's performance based on the clinical and non-clinical tests mentioned, and present them in a format that addresses your request where applicable. It's important to note that this is not a software/AI device, so many of your requested points (like data provenance, number of experts for ground truth, MRMC studies, standalone performance for an algorithm, training set details) are not directly applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device seeking substantial equivalence, specific numerical 'acceptance criteria' for efficacy in the way one would see for an AI diagnostic tool (e.g., sensitivity > X%, specificity > Y%) are not explicitly stated in this document. Instead, the "acceptance criteria" are implied by demonstrating that the device is "safe and effective" and "substantially equivalent" to predicate devices. The performance is reported in terms of general clinical outcomes.

• Biocompatibility: Compliant with ISO 10993 (cytotoxicity, sensitization, and irritation requirements).
• Locking Test: Confirmed that the circumcision clamp is secured properly.
• Force and break tests performed on the device. |
  | Effectiveness (Clinical Outcome) | - Easily applied in a short surgical procedure.
• No suturing required.
• Safe and effective means of performing circumcision on adult males.
• Designed to promote faster circumcision process, prevent severe bleeding with less pain. (Claimed design goal) |
  | Substantial Equivalence | - Substantially equivalent in clamping method, sterility, single use, no use of suture, and intended use to the predicate devices (Smart Klamp® and Shang Ring™).
• Differences in design do not raise new issues of safety and effectiveness. |
  | Materials | - Materials (Polycarbonate and ABS) meet biocompatibility requirements. |

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Clinical test were conducted" and "The clinical data collected confirms that the RAPIDECLAMP is a safe and effective means of performing circumcision on adult males." However, the exact number of patients enrolled in the clinical study is not provided in this summary.
• Data Provenance: The clinical tests were conducted in Malaysia at:
  • Ar-Raudhah Clinic
  • JB Specialist
• Retrospective/Prospective: Not explicitly stated, but clinical tests conducted at specific clinics typically imply a prospective study for device evaluation.

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

This question is not applicable as this is a physical medical device, not an AI or software diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for a surgical device's effectiveness would be observed clinical outcomes and safety profiles in patients, assessed by the medical practitioners conducting the procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software device requiring expert consensus on interpretations, there's no "adjudication method" in the context of resolving disagreements among experts. Clinical safety and effectiveness would be judged by treating physicians and potentially by independent review boards or regulatory bodies based on the aggregate clinical data.

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

Not applicable. An MRMC study is relevant for evaluating diagnostic performance of imaging systems or AI algorithms by comparing multiple readers' interpretations of cases. This device is a surgical clamp, not an interpretation tool.

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

Not applicable. This device is a physical surgical instrument and inherently involves a human operator (a medical doctor). The concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the assessment of this device's safety and effectiveness is based on clinical outcomes data gathered from the patients on whom the device was used. This would include observations related to:

• Ease of application and surgical procedure time.
• Prevention of severe bleeding and reported pain levels.
• Post-procedure healing and absence of complications.
• Overall assessment of safety and effectiveness by the medical professionals involved.

8. The Sample Size for the Training Set

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

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The ShangRing™ Circumcision Clamp intended use is for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.

Not Found

The provided documents are a FDA 510(k) clearance letter and an Indications for Use statement for the ShangRingTM Circumcision Clamp. These documents do not contain any information regarding acceptance criteria, device performance results, study details (sample sizes, data provenance, expert qualifications, adjudication methods), or ground truth establishment methods.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

To answer your request, I would need a different set of documents, such as a summary of safety and effectiveness data, a clinical study report, or a premarket submission document that details the performance testing and acceptance criteria for the ShangRingTM Circumcision Clamp.

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The ShangRing™ device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.

The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric rings made from polycarbonate. The outer ring is formed from two semi-circular halves that are joined together on one end by a hinge, and by interlocking ratchets on the opposite end. The inner ring is lined with a soft silicone band. The ShangRing is available in 14 sizes with inner ring diameters ranging from 26mm to 40mm. A disposable sizing guide is provided to assist in selecting the appropriate size ShangRing. The ShangRing is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare practitioner everts the patient's foreskin over the inner ring and the outer ring halves are locked together, sandwiching the foreskin between the two rings which effectively prevents bleeding. Skin forward of the crush line is trimmed away. After the procedure, the ShangRing device remains on the patient for 7 days. After 7 days, the ShangRing is removed by the healthcare practitioner.

The provided text describes the ShangRing™ circumcision device and its regulatory submission. While it mentions clinical evaluations, it does not explicitly define acceptance criteria in a quantitative manner or provide a detailed study report that proves the device meets specific performance metrics in a structured way that would allow for the direct extraction of acceptance criteria and reported performance in a table format.

However, I can infer the "acceptance criteria" and "reported device performance" based on the general conclusions drawn from non-clinical and clinical tests as stated in the document.

Here's an attempt to extract and present the information requested, with necessary inferences and notations where direct data is absent:

Derived Acceptance Criteria and Reported Device Performance

• Device must remain in place on the patient (skin retention) when exposed to anticipated forces. | - Force required to pull apart the locking mechanism was determined.
• Force required to pull skin out of the ShangRing in the locked position was measured.
  Conclusion: Possesses the required mechanical strength to prevent bleeding and remain attached to the foreskin for at least 7 days following closure of the locking ring. |
  | Clinical Safety | - Infrequent adverse events.
• Mild adverse events, requiring minimal management.
• Complication rates lower than conventional methods. | - Adverse events were infrequent.
• Adverse events were mild, requiring minimal management.
• Complication rates were lower than experienced with conventional methods.
  Overall Conclusion: ShangRing™ is a safe means of performing circumcision. |
  | Clinical Effectiveness | - Easily applied.
• Short surgical procedure.
• No suturing required.
• Performs circumcision effectively. | - Easily applied in a short surgical procedure.
• No suturing required.
  Overall Conclusion: ShangRing™ is an effective means of performing circumcision on adult males. The device achieves circumferential crushing of the foreskin. |
  | Wear Duration | Device should remain on the patient for 7 days. | Mechanical testing and clinical studies support the device remaining attached for at least 7 days, allowing for effective crushing and subsequent removal. (Implicit in the "remains attached for at least 7 days" and "device remains on the patient for 7 days" statements). |

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

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 for Test Set: Approximately 3000 cases.
• Data Provenance: Clinical evaluations were conducted in China and Kenya. The text does not explicitly state whether these studies were retrospective or prospective, but clinical evaluations for device efficacy and safety are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The document mentions "clinical evaluations" and "clinical data" but does not specify the number of individual experts (e.g., surgeons, physicians) involved in establishing the ground truth or their specific qualifications (e.g., years of experience, specialization). It refers to healthcare practitioners performing the procedures.

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

• The document does not describe any specific adjudication method for establishing ground truth or evaluating outcomes in the clinical studies. It broadly states "clinical evaluations" and "clinical data collected confirms."

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 applicable. The ShangRing™ is a physical surgical device (circumcision clamp), not an AI-assisted diagnostic or therapeutic tool for which MRMC comparative effectiveness studies (involving human readers improving with AI) would be relevant.

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

• No, this is not applicable. The ShangRing™ is a physical surgical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently tied to its use by a human healthcare practitioner.

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

• The ground truth for the clinical studies appears to be based on clinical outcomes data (e.g., successful circumcision, absence/presence and severity of adverse events, complication rates, ease of application, duration of procedure, requirement for sutures). These outcomes would have been observed and recorded by the treating healthcare practitioners.

8. The sample size for the training set

• The concept of a "training set" typically applies to machine learning algorithms. Since the ShangRing™ is a physical medical device, there isn't a "training set" in that sense. The device's design and mechanical properties are refined through engineering and non-clinical testing, while clinical "training" for the device's efficacy and safety for human use relies on the reported clinical evaluations.
• If "training set" is interpreted as initial smaller clinical trials or studies that informed the final design and understanding before the reported "extensive clinical evaluations," the document does not provide details on such distinct phases or their sample sizes. The "approximately 3000 cases in these two countries" represents the cumulative clinical experience reported to demonstrate performance.

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

• As above, the concept of a "training set" in the context of an AI/algorithm is not applicable here. For the clinical evaluations (which serve as the basis for understanding the device's performance and implicit "truth"), the ground truth was established through direct observation of clinical outcomes by medical professionals in China and Kenya. These outcomes included the successful completion of circumcision, the occurrence and nature of adverse events, and complication rates, as documented during standard clinical practice and research protocols.

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PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.

The PrePex is a device composed of three components; a plastic Inner Ring, an Elastic outer clamping Ring and a Placement Ring for applying the clamping Elastic Ring. The PrePex System is sold sterile for single use and is available in multiple sizes to accommodate variances in adult patients. A sizing guide is separately available, sold clean for single use

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document describes the PrePex device and its clinical studies, but does not explicitly define numerical acceptance criteria in a table format for performance metrics. Instead, the "acceptance criteria" are implicitly demonstrated through the study results showing safety and efficacy, and comparison to a predicate device.

However, based on the information provided, we can infer some performance indicators and present them in a table, noting that these are reported results, not pre-defined acceptance thresholds:

Study Information

Here's the detailed study information based on the provided text:

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

   • First Study: 50 healthy uncircumcised men aged 18 to 35 years. Data provenance: Retrospective - initiated and sponsored by the government of Rwanda. (The phrase "initiated and sponsored by the government of Rwanda" suggests the data was collected in Rwanda, but doesn't explicitly state the country of origin of all participants' data if some were referred from elsewhere, though highly probable to be Rwanda.)
   • Second Study: 180 participants, randomly divided into 2 unbalanced study arms:
     • PrePex arm: 120 subjects
     • Surgical circumcision arm: 60 subjects
   • Data provenance: Prospective, randomized, comparative study. Sponsored by the Government of Rwanda. (Implies data collected in Rwanda.)

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

   • First Study: "The device was placed and removed by a physician or a nurse..." and "experienced operators who participated in the first study" performed procedures in the second study. While not explicitly stated how many experts established the ground truth, the "physician or a nurse" and "experienced operators" indicate medical professionals were assessing outcomes. The document does not specify the exact number of experts or their specific qualifications (e.g., years of experience, specialization) beyond "physician or a nurse" and "surgeon highly experienced in adult male circumcision."
   • Second Study: "All PrePex Device procedures were performed by experienced operators who participated in the first study." "The surgical circumcision procedure used was the dorsal slit method which was performed by a surgeon highly experienced in adult male circumcision." Similar to the first study, specific numbers and complete qualifications of "experts" for ground truth are not detailed beyond "experienced operators" and "highly experienced surgeon."

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

   • The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the test set's outcomes. Outcomes appear to be directly observed and recorded by the medical professionals involved in the study (physicians, nurses, experienced operators, surgeons).

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual medical instrument for a surgical procedure, not an AI or imaging diagnostic tool that would involve "human readers" interpreting data with or without AI assistance. The comparative study was between two different circumcision methods: PrePex device vs. surgical circumcision.

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

   • No, this is a medical device (clamp) used for a procedure, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance is inherently "with human-in-the-loop" as it requires a healthcare professional.

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

   • The ground truth was based on clinical outcomes data and expert observation/assessment by healthcare professionals. This includes:
     • Achieving complete circumcision.
     • Absence of bleeding.
     • Adverse event rates (observed and recorded by medical staff).
     • Procedure times, preparation times, and healing times (measured outcomes).
     • Pain assessment (patient-reported via VAS, but assessed/monitored by clinicians).

7. The sample size for the training set:

   • This is a medical device, not an AI algorithm that requires a "training set" in the machine learning sense. Therefore, this question is not applicable. The "training" for the device would involve healthcare professionals being trained in its use.

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

   • As there is no "training set" in the AI sense, this question is not applicable.

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

The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries

The provided text describes a Medical Device: Medicon Mogen Circumcision Clamp, which is a reusable stainless steel instrument used to compress the foreskin of the penis during circumcision of a male infant or child.

Here's an analysis of the acceptance criteria and supporting study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The document describes a non-clinical laboratory study comparing the Medicon Mogen Circumcision Clamp to a predicate device (T. S. Medical Circumcision Clamp, K033403) to establish substantial equivalence.

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

• Sample Size: The document does not specify a "sample size" in the context of human subjects or a clinical test set. The testing performed was non-clinical laboratory testing on the device itself.
• Data Provenance: The data provenance is from non-clinical laboratory tests conducted on the Medicon Mogen Circumcision Clamp, likely at the manufacturer's facility or a contracted lab. The country of origin of the device manufacturer is Germany (MEDICON eG). This was a laboratory study, not a human study, so terms like "retrospective or prospective" are not directly applicable in the typical clinical sense.

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

• Not applicable. This was a non-clinical laboratory study involving material and mechanical performance testing, not human-centered data requiring expert ground truth for diagnostic accuracy. Standards (ASTM, ISO) served as the "ground truth" for material and performance specifications.

4. Adjudication method for the test set

• Not applicable. As this was a non-clinical laboratory study, there was no adjudication method involving expert review of results in the traditional sense of a clinical outcome. Compliance with established engineering and material standards determined acceptance.

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 instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.

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

• Not applicable. This is a physical medical instrument, not a software algorithm.

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

• The "ground truth" for the non-clinical tests was established by recognized international and national standards for surgical instruments and materials:
  • ASTM F 899-09 (Standard Specification for Stainless Steels for Surgical Instruments)
  • ISO 7153-1 (Surgical instruments — Metallic materials — Part 1: Stainless steel)
  • ASTM F 1089-10 (Standard Specification for Wrought Stainless Steels for Surgical Instruments Used in the Body)
  • ISO 13402 (Surgical instruments — General aspects including safety, marking and information provided by the manufacture)

8. The sample size for the training set

• Not applicable. This was not a machine learning or AI algorithm development; therefore, there was no "training set." The device itself was tested directly against established physical and material standards.

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

• Not applicable. (See point 8. above). The "ground truth" for the acceptance criteria was based on compliance with industry standards, not a training set.

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This device is used to grasp, crush and cut the penile foreskin on full term, newborn (up to 10 days) male infants.

AccuCirc Circumcision clamp/cutter

The provided text is an FDA 510(k) clearance letter for the AccuCirc Circumcision clamp/cutter. This document does not contain information regarding detailed acceptance criteria, study methodologies, or performance data for the device. Therefore, I cannot generate the requested table and study description based solely on the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating it met specific, quantitative performance acceptance criteria.

To answer your questions, I would need access to the actual 510(k) submission document (K061539) which would contain the performance testing data and acceptance criteria if such tests were conducted and submitted.

Therefore, I cannot provide the requested information from the given text.

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The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.

The provided 510(k) summary for the GMD Universal Circumcision Clamp does not contain information about acceptance criteria or a study proving the device meets them.

Instead, the document states:

"The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use."

This indicates that the device's substantial equivalence was established based on its similarity to a legally marketed predicate device (GOMCO Circumcision Clamp - K894201) and the long history of clinical use of this type of technology, rather than through performance-based acceptance criteria and a specific study.

Therefore, the requested tables and details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as they are not present.

In summary, none of the specific information requested regarding acceptance criteria and performance studies is available in the provided text. The 510(k) submission relied on substantial equivalence to a predicate device and existing clinical history rather than new performance data.

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