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The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.

The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The CRoC™ is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.

The Combat Ready Clamp (CRoC) device is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The new indication is for life-threatening bleeds of the carotid artery, as a last resort.

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the CRoC device, specifically for the additional indication of controlling life-threatening bleeds of the carotid artery, is that it must be capable of stopping simulated vessel blood pressure on neck area wounds.

Study Information

1. Sample Size and Data Provenance for Test Set:

   • The document states that the CRoC was tested using a "cadaver model." This implies a limited sample size, likely involving a small number of cadavers. The exact number is not explicitly stated.
   • The data provenance is not specified, but it can be inferred that it would be from a controlled laboratory setting where the cadaver model was used. It is a prospective study as it was conducted to demonstrate the device's capability.

2. Number and Qualifications of Experts for Ground Truth:

   • The document does not provide information on the number or qualifications of experts used to establish ground truth for this specific performance test.

3. Adjudication Method:

   • An adjudication method is not mentioned for this performance testing. The description suggests a direct measurement of "stopping simulated vessel blood pressure."

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

   • No MRMC comparative effectiveness study was performed or mentioned. This is a medical device designed for direct physical intervention, not an AI diagnostic tool, so such a study would not be relevant.

5. Standalone (Algorithm Only) Performance Study:

   • No standalone algorithm performance study was done. The CRoC is a physical medical device, not a software algorithm.

6. Type of Ground Truth Used:

   • The ground truth used was the direct observation and measurement of the device's ability to "stop simulated vessel blood pressure on neck area wounds" in a cadaver model. This can be considered a direct performance measurement against a simulated physiological condition.

7. Sample Size for Training Set:

   • Not applicable. The CRoC is a physical medical device and does not involve an AI algorithm that requires a training set.

8. How Ground Truth for Training Set Was Established:

   • Not applicable, as no training set was used.

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The Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

The da Vinci Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision cholecystectomy using the IS3000 da Vinci Si Surgical System.
The da Vinci Single-Site Instruments and Accessories consist of non-wristed, semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to provide grasping, cautery, cutting, clip ligation and suction/irrigation functions.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories. This notification seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on a new, comprehensive clinical study with predefined performance metrics.

Therefore, many of the requested elements of the response, such as a table of "acceptance criteria" and "reported device performance," the sample size for a test set, the number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or provided in this document.

The document focuses on demonstrating substantial equivalence through design modifications, technological characteristics comparison, and performance testing (bench and animal) rather than a human-in-the-loop clinical trial or a study designed to meet specific quantitative performance criteria against a clinical "ground truth."

Here's a breakdown of the information that can be extracted, with an explanation for the elements that are not applicable:

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

• Not applicable in the context of this 510(k) summary. This submission is for demonstrating "substantial equivalence" to a predicate device, not for establishing new performance criteria in a clinical setting against a definitive clinical outcome. The performance data presented are for demonstrating that the modified device functions as intended and is equivalent to the predicate, focusing on design inputs and safety.

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

• Not provided. The performance testing included "bench and animal" studies. The sample sizes for these tests (e.g., number of animals, number of bench tests) are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is also 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. Since this is not a study requiring human expert evaluation to establish a "ground truth" for a diagnostic or AI-assisted task, no information on experts for ground truth establishment is provided. The evaluation was primarily engineering-focused (mechanical, electrical, simulated use in animals).

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

• Not applicable. As no expert ground truth establishment is described, no adjudication method is relevant.

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. An MRMC comparative effectiveness study was not conducted as this device is a surgical instrument system, not an AI diagnostic tool requiring "readers" or evaluation of "human readers."

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

• Not applicable. This device is a surgical instrument system, not an algorithm, so "standalone algorithm performance" is not relevant.

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

• Not applicable in the clinical sense. The "ground truth" for this submission revolves around engineering specifications and functional performance. The device's "truth" is whether it performs its intended mechanical and electrical functions safely and effectively, as demonstrated via bench and animal testing. This is not a clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This is a hardware device submission, not an AI or machine learning application, so there is no "training set."

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

• Not applicable. See point 8.

Summary of the Study and Device Performance as described in the provided text:

Device: Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories

Predicate Device: The original Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories (cleared under K112208 on December 8, 2011).

Purpose of Submission (K120215): To demonstrate substantial equivalence of a modified version of the device to its predicate. Modifications include simplifying the back-end drive mechanism, minor design and dimensional changes to the distal grip, and moving from machined to molded components.

Table of Acceptance Criteria and Reported Device Performance (based on the context of this 510k):

Study Details:

• Type of Study: Performance testing (bench and animal) for substantial equivalence to a predicate device.
• Sample Sizes: Not specified.
• Data Provenance: Not specified (presumably conducted by Intuitive Surgical, Inc. in the US).
• Ground Truth Establishment: For this type of device, "ground truth" is established by engineering specifications, functional requirements, and safety standards, confirmed through controlled bench tests and simulated use in animal models. No human expert consensus on clinical outcomes or pathology is mentioned as this is a device modification submission, not a new clinical efficacy claim.
• Training Set/MRMC/Standalone AI: Not applicable as this is not an AI/ML device.

In essence, the "study" was a series of engineering and animal tests designed to confirm that design changes did not negatively impact the performance, safety, and effectiveness of the device when compared to the previously cleared predicate, thus maintaining substantial equivalence.

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The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.

The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.

The provided document is a 510(k) Summary of Safety and Effectiveness for Karl Storz Endoscopy-America, Inc.'s Laparoscopic Thermocoagulator accessories, dated November 26, 1999.

This document does not contain information regarding acceptance criteria, device performance results from a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The summary focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting a performance study with specific criteria and results. Therefore, I cannot complete the requested information based on the provided text.

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