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Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.

The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.

This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.

This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.

This document is a 510(k) premarket notification for a medical device called the "Neuroview® Instrument Holder (Model 300-33)." It is a re-correction of an earlier letter from 1999, indicating a substantial equivalence determination by the FDA.

Based on the provided text, there is no study described that "proves the device meets acceptance criteria" in the way a clinical trial or performance study would for an AI/algorithm-based device. This document is for a mechanical instrument holder and relies on demonstrating substantial equivalence to existing predicate devices. Therefore, many of the requested points are not applicable.

Here's an analysis based on the structure of your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, the "performance" is implicitly demonstrated through a comparison of technological characteristics to predicate devices, showing that it functions similarly and is intended for the same use. The key "performance aspect" is highlighted: "The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place."

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

Not applicable. This is a mechanical device, and the evaluation for 510(k) clearance is based on technological comparison to predicates, not on a "test set" of data in the context of an algorithm. There is no mention of country of origin for any data or retrospective/prospective studies.

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. There is no "test set" or "ground truth" to be established by experts for this type of mechanical device clearance.

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

Not applicable. No test set or adjudication method is described.

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 mechanical instrument holder, not an AI or algorithm-based device. No MRMC study was done, and the concept of human reader improvement with AI assistance is entirely irrelevant here.

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

Not applicable. This is not an algorithm, so a standalone performance study as described is irrelevant.

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

Not applicable. No "ground truth" data of this type is used for this mechanical device. The "truth" in this context is that the device functions as intended (holding an endoscope in place) and is safe and effective because it is substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for a mechanical device like this.

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

Not applicable. There is no training set or ground truth in this context.

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The Beverly Referential Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the peritoneum or the right atrium of the heart.

The Beverly Referential Valve is intended to minimize the effect of hydrostatically induced flow when the patient is sitting, standing or semi-recumbent when compared to devices not containing an anti-siphon device.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's instructions for use.

Prescription Use Only (Per 21 CFR 801.109)

Beverly Referential Valve

The provided text is a 510(k) clearance letter from the FDA for the "Beverly Referential Valve with Integral Peritoneal Catheter." It states that the device is substantially equivalent to a predicate device but does not contain any information regarding acceptance criteria, device performance results, or details of a study.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies. The document only confirms the device's clearance for marketing.

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The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.

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The provided text is a 510(k) clearance letter from the FDA for the "Maurice Worldwide Shunt System." It states that the device is substantially equivalent to a predicate device and can be marketed. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval document and does not describe the specific tests or data used to support the substantial equivalence claim. Therefore, I cannot extract the requested information from the provided input.

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The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.

External CSF Drainage Management Systems

This 510(k) submission (K972994) for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems does not contain a study demonstrating the device meets specific acceptance criteria in the format typically seen for AI/ML devices. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is safe and effective because it is similar to devices already legally marketed.

Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or reported in this document.

Here's a breakdown based on the provided text, heavily emphasizing the substantial equivalence argument:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Absence of Direct Performance Metrics:

The document explicitly states: "The determination of safety and efficacy for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems is based on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A)..." and "Heyer-Schulte NeuroCare determines substantial equivalence and safety and efficacy of the Hever-Schulte NeuroCare External CSF Drainage Management Systems based on predicate and currently marketed devices as noted in the summary above."

This indicates that a direct, new performance study with specific quantifiable acceptance criteria for this particular device was not conducted or submitted as part of this 510(k). Instead, the argument is that because the device is functionally, materially, and operationally similar to already approved devices, it can be presumed to meet similar safety and efficacy standards.

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

• Not applicable (N/A) / Not reported. This information is not present because a dedicated "test set" and a study to evaluate performance against specific acceptance criteria were not part of this 510(k) submission. The reliance is on the equivalence to existing devices' performance and clinical history.

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)

• N/A / Not reported. The concept of "ground truth" as it pertains to a new performance study's test set is not relevant here due to the substantial equivalence pathway chosen.

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

• N/A / Not reported. This relates to performance studies that are not described in the submission.

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 a medical device for CSF drainage, not an AI/ML diagnostic tool involving human readers. Therefore, an MRMC study is not applicable.

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

• N/A. This is a physical medical device, not an algorithm.

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

• Historical clinical outcomes of predicate devices. The "ground truth," in an indirect sense, is derived from the established safety and efficacy profiles and long-term clinical use of the predicate devices. The submission leverages this existing "truth" rather than establishing a new one for this specific device.

8. The sample size for the training set

• N/A / Not reported. The device is not an AI/ML algorithm that requires a training set.

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

• N/A / Not reported. As above, not an AI/ML algorithm.

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The Rivetti-Levinson Intraluminal Shunt is indicated for use in preventing ischemia during the construction of coronary artery bypass grafts (either saphenous vein or of mammary artery) in the non-arrested heart.

Intraluminal shunting is indicated for temporary perfusion of the distal coronary lumen as an adjunct to the surgical technique and as a mechanism to prevent myocardial ischemia while the target coronary artery is opened and surgically grafted to a donor vessel.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "Rivetti-Levinson Intraluminal Shunt". It states that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The trade name of the device.
• Regulatory class and product code.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulations the device is subject to.
• Indications for use of the device.

However, it does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi reader multi case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a clinical study report or a technical performance evaluation.

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The Peritoneal/Cardiac Catheter is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the peritoneal cavity of the right atrium of the heart. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Not Found

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) clearance letter for a Peritoneal/Cardiac Hydrocephalic Shunt Catheter, indicating that the device has been found substantially equivalent to a predicate device.

Therefore, I cannot populate the requested table and information based on the provided text. The document refers to the "indications for use" as being in an enclosure, but the enclosure itself is not provided. There is no mention of performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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The major indication of external drainage is the management of hydrocephalic shunt infections. External drainage of cerebrospinal fluid (CSF) to control increased intercranial pressure may also be indicated if an internal shunt is not indicated or during the treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician.

Lumbar Drainage Accessory Kit

The provided text is a 510(k) clearance letter from the FDA for a device called "Lumbar Drainage Accessory Kit". It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (training or test sets), expert qualifications, ground truth establishment, or multi-reader multi-case studies.

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 provided input.

The document primarily focuses on the FDA's determination of substantial equivalence for the device to previously marketed devices and outlines regulatory responsibilities. Section 8 ("DEVICE INDICATIONS FOR USE") describes the intended uses of the device but does not include any performance data or study details.

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