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

AI/ML Overview

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

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

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

Acceptance Criteria (Study Performed)	Standard/Method Referenced	Reported Device Performance	Comments
Balloon Integrity, Volume, Leak Testing	Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99)	Assumed to meet the standard and be comparable to predicates.	Bench testing. Specific quantitative results (e.g., leak rate in ml/hr, volume retention percentage) are not provided in this summary.
Balloon Burst Testing	Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99)	Assumed to meet the standard and be comparable to predicates.	Bench testing. Specific quantitative results (e.g., pressure at burst) are not provided.
Biocompatibility Testing	ISO 10993 series	Compliant with ISO 10993 series.	Conducted using Good Laboratory Practices (GLP). Demonstrates material safety for biological contact.
Sterility Testing	FDA guidances and recognized international standards	Assumed to meet established sterility standards.	Ensures the device is safe for patient use.
Performance Testing	FDA guidances and recognized international standards	Assumed to meet established performance standards and be safe and effective.	General statement indicating overall functionality.
Substantial Equivalence (Overall)	Comparison to predicate devices (K861385, K880497)	Found to be substantially equivalent in technology, materials, intended use, indications for use, patient population, performance, and size.	The FDA concurred with this assessment in their decision letter.

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

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

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

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

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

4. Adjudication method for the test set

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

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

No. This information is not present in the document. The device is a physical medical instrument (catheter), not an AI-assisted diagnostic or interpretive tool.

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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