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The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.

Laryngeal Augmentation Implant

I am sorry, but based on the provided document, there is no information about the acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any details related to AI/MRMC studies for the Laryngeal Augmentation Implant.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the regulation number, product code, and indications for use. However, it does not include the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth without further information.

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DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). DRG SoftRelease is not intended for use in pregnant women.

The DRG SoftRelease is a single use, disposable, manual gynecological device intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). The device consists of a handle with a release mechanism, a spatula disc, and a brush. The common handle / release combination allows the attachment of a brush attachment for use in cervical or vaginal wall cell collection. The attachment of either the spatula or the brush allows for the release of the cell collector attachments from the device handle.

The brush is composed of bristles joined to a wire shaft. For collecting cervical cells, the brush is inserted into the cervix until only the last row of bristles are visible, rotated once via the handle, and removed from the site for transfer of the cytological material.

The spatula is made of plastic and is curve-shaped, similar to the widely used Ayre spatula. For collecting cervical cells, the spatula's blunt edge is placed against the cervix, rotated with gentle pressure on the handle, and removed from the site for transfer of the cytological material.

The provided document is a 510(k) Premarket Notification for the "DRG SoftRelease" device, a cervical cell scraper/sampler. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria, sample sizes, and expert adjudication as would be found in a study report for a new AI/diagnostic device.

Therefore, the requested information regarding acceptance criteria, reported performance against those criteria, detailed study design, sample sizes, ground truth establishment, and MRMC studies is not present in this document. This type of information is typically found in clinical trial reports or performance studies, which are not included in a 510(k) summary focused on substantial equivalence for a manual device.

However, I can extract the information that is present and explain why other requested information is not available:

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

• Not applicable / Not provided. This document is a 510(k) summary for a manual device (cervical cell scraper), not a diagnostic algorithm or AI device. It does not contain acceptance criteria for performance metrics (like sensitivity, specificity, or F1-score) or reported device performance against such criteria. The device's "performance" is implicitly tied to its ability to collect cervical cells, which is assumed to be equivalent to predicate devices.

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 / Not provided. The document does not describe a clinical study with a test set of data. Its purpose is to demonstrate substantial equivalence to existing devices based on "indications for use, design, materials, and principles of operation." There is no mention of a test set, data provenance, or study type (retrospective/prospective).

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 / Not provided. As no test set or clinical study is described, there is no information about experts establishing ground truth.

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

• Not applicable / Not provided. No test set 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 / Not provided. This device is a manual cervical cell collection instrument, not an AI or imaging device that would involve human readers or MRMC studies.

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

• Not applicable / Not provided. This is a manual medical device, not an algorithm.

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

• Not applicable / Not provided. As no clinical study or performance evaluation against a ground truth is described, this information is not available. The "ground truth" for this type of device is simply the successful collection of representative cervical cells for subsequent lab analysis by pathologists, which is outside the scope of this 510(k) document.

8. The sample size for the training set

• Not applicable / Not provided. This is a physical, manual device, not an AI or machine learning model that requires a training set.

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

• Not applicable / Not provided. Not an AI/ML device.

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The DRG Disposable Vaginal Speculum is indicated for use to expose the interior of the vagina.
The DRG Disposable Vaginal Speculum is indicated for diagnostic procedures of the vagina and cervix.

The DRG Disposable Vaginal Speculum consists of a plastic inflatable bladder The DNO Disposable Vaginal of to uniformly press the vaginal walls open.

The provided text is a 510(k) premarket notification summary for the DRG Disposable Vaginal Speculum. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or statistical analyses as would be required for a detailed description of device performance and its proof against acceptance criteria.

The 510(k) process primarily evaluates a new device for "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove performance against specific acceptance criteria in the manner an AI/ML medical device might. The core argument for substantial equivalence for this device would likely revolve around materials safety, design similarity, and functional equivalence to existing vaginal specula.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided document. This information is simply not present in this type of regulatory submission for this device.

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The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.

The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the DRG Reaction Chamber/Safety Tip, primarily focusing on its substantial equivalence to a predicate device for market clearance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies.

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QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.

The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it. The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.

The provided text describes a 510(k) premarket notification for the DRG QuickMix Mixing System for BoneSource® Hydroxyapatite Cement (HAC). This document is focused on establishing substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria through measured performance.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The 510(k) summary primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device.

Here's an breakdown of what can be extracted or inferred from the provided text, and where information is missing:

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

This information is not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria for the QuickMix system itself. The predicate device, BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit, would have had performance data, but that is not detailed here for the QuickMix mixing system.

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

This information is not present in the 510(k) summary. A 510(k) submission for a mixing system typically relies on demonstrating that the mixing process yields a material that meets the specifications of the cement itself, which would have been established for the predicate device. It doesn't detail a separate "test set" in the context of clinical trials or algorithm performance.

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)

This information is not applicable/not present. The 510(k) summary for a mixing system does not involve establishing ground truth from expert consensus in the way a diagnostic AI device would.

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

This information is not applicable/not present. As above, the nature of this submission does not involve adjudication methods related to expert consensus on clinical data.

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

This information is not applicable/not present. The device (a cement mixing system) is not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are irrelevant.

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

This information is not applicable/not present. The device is a physical mixing system, not an algorithm.

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

This information is not applicable/not present in the context of the QuickMix system itself. The system is a tool for preparing a medical material (BoneSource HAC). The performance validation would typically involve chemical and physical property testing of the mixed cement to ensure it meets specifications, rather than clinical ground truth as described.

8. The sample size for the training set

This information is not applicable/not present. The device is not an AI algorithm that requires a "training set."

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

This information is not applicable/not present. As above, the device is a physical mixing system, not an AI algorithm.

Summary of what is present and its relevance:

• Acceptance Criteria & Performance: The document implicitly aims to demonstrate that the QuickMix Mixing System, when used with BoneSource HAC, produces a cement that is substantially equivalent in its properties and intended use to the predicate device (BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit distributed by Stryker Leibinger K991398). The performance would be related to the consistency and quality of the mixed cement, but specific metrics and acceptance criteria for this mixing system are not detailed in this summary. The "study" proving this would be a series of tests verifying the mixed cement's properties (e.g., setting time, strength, handling characteristics) match those of the predicate.
• Sample Sizes: Not relevant or provided for this type of submission.
• Experts/Ground Truth: Not relevant for this type of submission focused on a physical mixing device.
• Study Type: This is a 510(k) Premarket Notification document. The "study" isn't a traditional clinical trial as described in the prompt. It's a regulatory submission demonstrating substantial equivalence to a predicate device. This means showing that the QuickMix system does not raise different questions of safety and effectiveness than the previously cleared Stryker Leibinger system (K991398). This substantial equivalence is typically supported by bench testing, material characterization, and comparison of design and intended use, rather than large-scale human clinical trials or expert evaluation of outputs in the way a diagnostic device would.

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The DRG OrthoHex SS bone screws are intended for orthopedic trauma and reconstruction.

DRG OrthoHex SS Bone Screw

The provided document is an FDA 510(k) clearance letter for a medical device (DRG Orthohex SS Bone Screw). It does not contain any information regarding acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on clinical performance or AI-related evaluations.

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The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.

Conventional Electronic Digital Stethoscope

This document is a marketing clearance letter from the FDA for a conventional electronic digital stethoscope (K991714) and does not contain the specific details about acceptance criteria or a study that proves the device meets such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

Therefore, the device was cleared based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a new performance study. Information about acceptance criteria and a detailed study fulfilling those criteria would typically be found in the 510(k) submission itself, which is not provided here.

Based on the provided text, I cannot answer the questions about acceptance criteria or a specific study proving the device meets them because the document is an FDA clearance letter, not the submission containing that information.

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The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.

DRG LockJaw™ 15 Minute Intermaxillary Fixation System

This is a scanned FDA letter for a 510k submission for the DRG LockJaw™ 15 Minute Intermaxillary Fixation System. Unfortunately, the letter does not contain the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.).

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls. The letter also includes the stated indications for use of the device.

Therefore, I cannot provide the detailed information you requested based solely on the provided text. To get this information, you would typically need to review the full 510(k) summary or submission documents, which are not included here.

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DRG Ti Bone Plates are intended for craniofacial and mandibular trauma and reconstruction.

DRG Titanium Bone Plate

This document is a 510(k) clearance letter from the FDA for a medical device called the "DRG Titanium Bone Plate." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for a new AI/software medical device.

The clearance letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. It mentions the "indications for use" for the bone plate, but this is a statement of what the device is intended for, not performance metrics.

Therefore, I cannot provide the requested information based on the provided text. The document is about a hardware medical device (a bone plate) and its regulatory clearance, not an AI or software-based medical device performance study.

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