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This device is a protective finger guard accessory to the surgeon's glove. (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. (b) Facilitate suture handling and placement.

This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.

The provided 510(k) summary for the MARINA MEDICAL FINGER PROTECTOR (K042534) does not describe a clinical study or performance tests with specific acceptance criteria and reported device performance in the way a typical diagnostic device submission would. Instead, this submission relies on demonstrating substantial equivalence to a predicate device (DIGICAP, K012199) primarily through comparison of technological characteristics.

Therefore, the acceptance criteria and study information will be presented reflecting this approach.

Acceptance Criteria and Study Proving Device Meets Criteria

The Marina Medical Finger Protector (K042534) sought clearance by demonstrating substantial equivalence to a predicate device (DIGICAP, K012199). The "acceptance criteria" in this context are the demonstrated identical technological characteristics to the predicate device, which inherently implies identical performance, safety, and effectiveness. The "study" proving this largely involves a comparative analysis against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: "Energy used and/or delivered", "Electrical safety", "Thermal safety", and "Radiation safety" were deemed "Not applicable" for this device and thus were not criteria for comparison.

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

There was no "test set" in the traditional sense of clinical data or performance measurements on a specific sample size of the device. The comparison was based on the technological characteristics and established performance of the legally marketed predicate device (DIGICAP, K012199). Data provenance for such comparison would be the established regulatory clearances and documentation of the predicate device.

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

Not applicable. Ground truth was not established by experts for a specific test set, as no clinical or performance study with a test set was conducted for this submission. The ground truth for device safety and effectiveness was established through the prior clearance of the predicate device and the comprehensive comparison of characteristics.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication 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

Not applicable. This device is a sterile single-use protective finger guard, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for the clearance of the Marina Medical Finger Protector was the demonstrated substantial equivalence to a predicate device (DIGICAP, K012199) that had already been deemed safe and effective. The premise is that if the new device is technologically identical to a legally marketed device, it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. No training set was used for an algorithm.

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

Not applicable. No training set for an algorithm was used or required.

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This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL. (with and without support), HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).

CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ; indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild seconddegree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.

This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support). HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).

All models with their dimensions are detailed within the labeling section of this submission.

The provided text describes a 510(k) summary for the "MARINA MEDICAL SILICONE PESSARY" and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria for the new device as a standalone product.

Therefore, many of the requested elements regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth are not applicable or not explicitly stated in this type of submission. The safety and effectiveness are claimed based on the similarity to a previously cleared device.

Here's an analysis of the provided text in relation to your request:

1. Acceptance Criteria and Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set with patient data for performance evaluation is mentioned.
• Data Provenance: Not applicable. The submission relies on a comparison to a predicate device, not new clinical data from a test set.

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

• Number of Experts: Not applicable. No ground truth establishment for a test set is described. The clearance is based on comparison to an existing predicate device and its known safety/effectiveness profile, as well as material specifications and intended use.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring adjudication is described.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, which would typically involve human readers (e.g., clinicians) evaluating cases with and without the device's assistance.

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

• Standalone Study: No. This device is a physical medical device (vaginal pessary), not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study does not apply.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of device performance data. The "truth" in this submission relates to the intended use, material composition, and design principles being similar to those of a legally marketed predicate device. The ground truth for the predicate device would have been established historically through its own clearance process, clinical experience, and regulatory standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of a 510(k) for a physical device usually refers to product development, materials testing, and manufacturing processes, not data-driven model training.

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

• Ground Truth for Training Set: Not applicable. See point 8.

Summary of 510(k) Process (as demonstrated here):

This 510(k) submission is for a Class II medical device. The primary method for clearance is to demonstrate substantial equivalence to a predicate device. This typically involves:

• Comparison Table: A detailed comparison of the new device to the predicate device, highlighting similarities in intended use, technological characteristics (materials, design, performance), and safety/effectiveness profiles. (Paragraph 14, mentioned but not included, would likely contain this table).
• Performance Data (often bench testing): For physical devices like pessaries, this usually involves material biocompatibility, mechanical strength, and dimensional integrity testing to ensure it meets established standards and is comparable to the predicate. The provided text doesn't detail these study results but implies they were part of the rationale for equivalence.
• Labeling and Indications for Use: Ensuring the proposed indications for use are consistent with those of the predicate device.

The FDA's letter confirms that they have reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing the company to market it. This process does not typically involve the type of detailed clinical performance studies with explicit acceptance criteria, expert adjudication, or AI-specific terminology (like test sets, training sets, MRMC studies) that would be seen for novel devices, high-risk devices, or AI/ML-enabled devices.

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THE DEVICE IS INDICATED FR USE To Rt MATERIAL THE UTERUS 1010 UTERUS By SCRAPING / / N THE AND SUCTION IN ORDER TO OBTAIN નિર રે. 151-624 LOGICAL MENSTRALAL of for EXTRACTIO

The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.

The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.

The provided text describes a 510(k) summary for the "Marina Ampler Sampler (MAS) with and without syringe," which is an endometrial suction curette. The document aims to demonstrate substantial equivalence to a predicate device, the "Curelle from Bioteque Corporation" (510k #K915491).

However, the submission does not contain acceptance criteria for a device's performance that would require a study to prove it meets those criteria. Instead, it focuses on demonstrating substantial equivalence in technological characteristics to a legally marketed predicate device.

Therefore, the requested information cannot be fully provided as it pertains to a different type of validation and performance evaluation than what is presented in this 510(k) summary.

Here's an breakdown of why the requested information isn't available in this document:

1. Acceptance criteria and reported device performance (Table): Not applicable. This document is a 510(k) summary for a Class II device, where the primary goal is to show the new device is as safe and effective as a predicate device, not necessarily to meet specific, quantifiable performance thresholds with a new, standalone study. The table provided (paragraph 14) compares technological characteristics to the predicate device, not performance against pre-defined acceptance criteria. The performance is stated as "Identical" to the predicate.

2. Sample size, data provenance for test set: Not applicable. No clinical outcome or diagnostic performance test set is described. The comparison is based on design, materials, and intended use as compared to the predicate device.

3. Number of experts and qualifications for ground truth: Not applicable. Ground truth, as typically used in the context of diagnostic accuracy studies (e.g., for AI/imaging devices), is not established or discussed here.

4. Adjudication method: Not applicable. No test set requiring expert adjudication for ground truth is present.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a medical device (endometrial suction curette), not an AI/imaging diagnostic device that would typically undergo such a study to evaluate human reader improvement with AI assistance.

6. Standalone (algorithm only) performance: Not applicable. This device is a manual medical instrument not an algorithm.

7. Type of ground truth used: Not applicable. As explained above, ground truth in the context of performance evaluation of diagnostic algorithms is not part of this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. Sample size for training set: Not applicable. This is not an AI/machine learning device. No training set is involved.

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

Summary of Device Equivalence (from Paragraph 14):

The submission demonstrates substantial equivalence by comparing the Marina Ampler Sampler (MAS) with and without syringe to the predicate device, Curelle from Bioteque Corporation (510k #K915491), based on technological characteristics.

The study described here is a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device, rather than a performance study against predefined acceptance criteria for a novel device or an AI algorithm.

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THE HEMORRHAGE OCCLUDER PIN IS INDICATED TO BE USED TO STOP MASSIVE PRESACRAL HEMORRHAGE DURING SURGERY

HEMORRHAGE OCCLUDER PIN (HOP) is of 7mm length and 8mm pinhead. It is made out of medical grade Titanium suitable for implantation.

The provided text is a 510(k) summary for the HEMORRHAGE OCCLUDER PIN (HOP), which is an implantable staple. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth), and training set details cannot be extracted from this document as such a study is not described.

The summary states:

• "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)"
• "Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution."

This indicates that the submission relies on demonstrating similarity to a previously approved device rather than presenting a new clinical performance study with specific acceptance criteria and detailed results.

In summary, the document does not contain the information required to populate the outlined sections.

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