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The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.

The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below. The modifications described in this Special 510(K) are listed below: 1. A new motor has been installed which provides additional torque and speed to the handpiece. 2. The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.

The provided text is a 510(k) premarket notification for the Advantage® Turbo Drive System, which is an electric cranial drill motor. The document describes modifications to an existing device, primarily a new motor and updated software to increase speed and torque.

However, the document is a regulatory submission for a medical device that performs cutting of soft tissue and bone and does not involve any AI/ML components or software for diagnostic or screening purposes.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to AI/ML device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training data, etc.). The provided text does not contain any of that information because it describes a mechanical surgical tool, not an AI/ML algorithm.

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The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Wands are bipolar, single use, high frequency electrosurgical devices.

This document describes a Special 510(k) submission for the ArthroCare Perc-D SpineWand, proposing modifications in dimensional and performance limits, materials, and labeling. The submission asserts that these changes are not substantial and do not significantly affect safety or efficacy. Therefore, a comprehensive study to establish new acceptance criteria and prove device performance against them, as if it were a novel device, was not conducted or required. The information provided focuses on demonstrating substantial equivalence to a previously cleared device.

Here's an analysis based on the provided text, addressing the requested points:

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

Based on the provided text, no specific quantitative acceptance criteria or objective performance metrics are reported for the modified Perc-D SpineWand. The submission is a "Special 510(k)" which indicates that the changes are minor and primarily relate to dimensional and performance limits, materials, and labeling, asserting that these do not significantly affect safety or efficacy. The "Substantial Equivalence" section states: "The modified Perc-D Wands, as described in this submission, are substantially equivalent to the predicate device...The proposed modification in dimensional and to the producer, specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, no direct table of acceptance criteria and associated performance results is available in this document. The "acceptance criteria" here are implicitly met by demonstrating that the modifications do not alter the fundamental safety and effectiveness profile established for the predicate device.

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

No new test set or clinical data is mentioned for this Special 510(k) submission. The submission relies on the substantial equivalence to the predicate device (K010811), which was cleared on May 30, 2001.

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. No new test set or clinical data requiring expert ground truth establishment for a diagnostic or AI device is described.

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

Not applicable. No new test set or clinical data requiring adjudication 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 device is an electrosurgical tool, not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is an electrosurgical device, not an algorithm.

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

Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for the device's efficacy and safety would have been established during the clearance of the predicate device (K010811) through appropriate non-clinical testing and potentially clinical data, as required for that submission.

8. The sample size for the training set

Not applicable. This device is an electrosurgical tool and does not involve AI/machine learning models requiring a training set.

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

Not applicable. See point 8.

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The Symphony Graft Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Symphony Graft Delivery System Syringe is designed specifically to collect, mix and deliver bone graft materials to a surgical site. The Graft Chamber component of the Symphony GDS can be provided either empty or pre-filled with human allograft

The provided text describes the 510(k) summary for the Symphony Graft Delivery System (K012738), which is a device intended for the delivery of bone graft materials. However, the document does not contain information about acceptance criteria, device performance metrics, or any study involving human readers or ground truth establishment.

The "PERFORMANCE DATA" section only states that the resins used for the device components meet biocompatibility requirements (Tripartite Biocompatibility Guidance for Medical Devices, Pharmacopeia XXII, Class VI, and FDA modified ISO 10993-1 tests). This is a statement about material safety and biocompatibility, not about the performance of the device in its intended use (delivery of graft material).

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets specific performance acceptance criteria related to its function of delivering bone graft materials.

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To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

Not Found

I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) clearance letter for a "Med'ext 1000 Surgical Drill," indicating it has been deemed substantially equivalent to a predicate device. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for either test or training sets.
• The sample size for the training set.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed performance study report.

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The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.

The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne.

This document is a 510(k) summary for a medical device (Aqua Spray). It explicitly states "Non-clinical tests: Not applicable" and "Clinical tests: Not applicable" and "Test summary: Not applicable".

Therefore, the study that proves the device meets acceptance criteria, and consequently, the acceptance criteria themselves, are not provided in the given text. This device was granted substantial equivalence ("K971941") without the need for clinical or non-clinical performance testing. The substantial equivalence was based on its similarity to a legally marketed predicate device (Podo Spray) in terms of intended use and technological characteristics.

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To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

Bone and Marrow Collection System (BMCS) Instrument Kit

I am sorry, but based on the provided document, the information required to answer your request is not available. The document is a 510(k) clearance letter from the FDA for a "Bone and Marrow Collection System Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain:

1. Acceptance criteria and reported device performance: It only states the device is "substantially equivalent" but does not provide specific performance metrics or criteria.
2. Details of the study: There is no mention of a clinical or performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
3. Training set information: As no study details are provided, there is no information on a training set or its ground truth.

The document is primarily a regulatory approval letter, indicating the device can be legally marketed based on its equivalence to existing devices, rather than a detailed report of a performance study.

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To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.

Bone and Marrow Collection System (BMCS)

This document is a 510(k) premarket notification letter from the FDA regarding a "Bone & Marrow Collection System." It indicates that the device has been found substantially equivalent to predicate devices marketed prior to May 28, 1976. This specific type of document does not contain information about acceptance criteria or specific studies demonstrating performance.

The FDA 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or performance against specific, pre-defined acceptance criteria through a study as would be detailed for a novel or high-risk device. The letter simply states the device is "substantially equivalent" for its stated indications for use (found on page 2 of the document).

Therefore, based solely on the provided text, I cannot provide the information requested:

1. A table of acceptance criteria and the reported device performance: Not present in this document.
2. Sample size used for the test set and the data provenance: Not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in this document.
4. Adjudication method for the test set: Not present in this document.
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 present in this document. This is also highly unlikely for a bone and marrow collection system, which is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present in this document. Again, this is not relevant for this type of device.
7. The type of ground truth used: Not present in this document.
8. The sample size for the training set: Not present in this document.
9. How the ground truth for the training set was established: Not present in this document.

For a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a battery of non-clinical tests (e.g., biocompatibility, sterility, mechanical testing, performance testing compared to the predicate device) rather than clinical studies with human participants and ground truth establishment in the manner described in your prompt, especially for Class I devices like this one. The acceptance criteria would be defined by the manufacturer and often relate to these non-clinical performance aspects and comparison to the predicate. This information would typically be in the 510(k) submission itself, not the FDA's decision letter.

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1. Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.

The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.

This 510(k) premarket notification (K964252) focuses on establishing substantial equivalence for the ORTHOCHUCK™, a device designed to convert standard keyed metal chuck head surgical drives into keyless chuck drives. The submission primarily relies on a comparison to existing predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state formal quantitative acceptance criteria for device performance. Instead, it uses a comparison table to demonstrate how the ORTHOCHUCK™ is functionally equivalent to or improves upon predicate devices. The "reported device performance" is essentially its functional characteristics relative to these predicates.

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

The document does not describe a formal performance study with a "test set" in the sense of clinical or laboratory data for statistical analysis. The determination of substantial equivalence is based on a comparison of design, materials, and intended use with legally marketed predicate devices.

• Sample Size: Not applicable as no specific test set data is presented.
• Data Provenance: Not applicable. The "data" consists of the features and characteristics of the device and its predicate devices, as described in the comparison table and device description.

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)

No external experts were used to establish "ground truth" for a test set, as no test set data was presented. The ground truth, in this context, refers to the established functional characteristics of existing surgical chucks, which are common knowledge in the orthopaedic surgical field. The comparison is made against these known characteristics.

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

Not applicable. There was no test set requiring expert adjudication.

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 mechanical surgical accessory, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to its evaluation.

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

Not applicable. The ORTHOCHUCK™ is a mechanical accessory designed to be used by a human surgeon or assistant. It does not operate as an algorithm or autonomously.

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

The "ground truth" implicitly used for this submission is the established functional performance and safety characteristics of existing legally marketed predicate devices (both keyed and keyless chucks), combined with the detailed design and material specifications of the ORTHOCHUCK™ itself. This reflects an engineering and functional comparison, rather than a clinical outcomes study.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system, so there is no concept of a "training set."

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

Not applicable. As there is no training set.

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