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The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired.

The provided text describes a 510(k) submission for the PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories. However, it does not contain information about acceptance criteria, device performance, sample size for testing or training, expert qualifications for ground truth, or adjudication methods.

The submission is primarily focused on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and clinical evidence in the form of published clinical data and other information, rather than a new clinical study with specific performance metrics and acceptance criteria.

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

Here's an analysis based on the available information:

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

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

• Sample Size: Not specified. The submission refers to "Published clinical data and other information" without detailing specific studies or sample sizes.
• Data Provenance: Not specified.

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

• Not applicable/Not specified. The submission relies on existing clinical data and the substantial equivalence principle, not a new test set with expert-established ground truth.

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

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, this is not an AI-based device, and no MRMC study is mentioned.

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

• Not applicable. This is a surgical stapler, not an algorithm.

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

• Not explicitly stated for this 510(k) submission itself. For the "Published clinical data" referenced, it would typically involve clinical outcomes data from surgical procedures where the device was used.

8. The sample size for the training set

• Not applicable/Not specified. This is a hardware device, not a machine learning model requiring a training set.

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

• Not applicable.

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The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories is available in a 33 mm diameter size only. The instruments allow the surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed to facilitate insertion, operation and removal.

The provided text is a 510(k) summary for a medical device called the PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories. It describes the device, its intended use, and indicates that pre-clinical laboratory evaluations were performed to ensure acceptable performance. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria.

The available performance data section states: "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in pressure holding capability, staple form and height as well as other stapling parameters."

This is a very high-level statement and does not provide the necessary details to answer the request in full.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies based solely on the provided text.

Here's how I would present the information based on the input, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text only states that performance was "acceptable" and comparable to a predicate device. It does not specify the quantitative acceptance criteria (e.g., "pressure holding capability must be > X mmHg" or "staple height must be Y ± Z mm"). Without these details, a complete table cannot be generated.

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

The document mentions "Pre-clinical laboratory evaluations" but does not specify the sample size used for these tests.

• Sample Size (Test Set): Not specified.
• Data Provenance: Pre-clinical laboratory evaluations. The country of origin is not explicitly stated, but the device manufacturer is based in Cincinnati, Ohio, USA. It is a prospective evaluation as it was performed to ensure the device "can be used as designed."

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

The document describes "Pre-clinical laboratory evaluations," which typically involve engineering and bench testing, not subjective expert evaluation of data. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or clinical outcomes is not relevant or detailed in this context.

4. Adjudication method for the test set

Given that the evaluations were "pre-clinical laboratory" studies focusing on physical properties like "pressure holding capability, staple form and height," adjudication methods like 2+1 or 3+1 are not applicable. These methods are usually for subjective assessments or disagreements in clinical diagnoses. The document does not describe any such adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC study was not performed. This device is a surgical stapler, not an AI-assisted diagnostic tool for human readers.
• Effect size of human readers with/without AI: Not applicable, as this is not an AI-powered diagnostic device.

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

• Standalone Performance: Not applicable for this device. This is a mechanical surgical device, not an algorithm. The "performance data" refers to the device's physical and mechanical performance.

7. The type of ground truth used

The "ground truth" for the pre-clinical laboratory evaluations would have been based on:

• Engineering specifications and design requirements (for stapling parameters, form, height).
• Quantitative measurements (e.g., pressure gauges, calipers for staple dimensions).
• Comparison against the performance of the legally marketed predicate device (PROXIMATE® Curved and Straight Intraluminal Staplers).

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Performance evaluations for mechanical devices analyze test samples (e.g., a batch of staplers, or multiple firings). The document does not specify this sample size.

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

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

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