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The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.

This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,

Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.

The provided document is a 510(k) summary for the Bio-Ray SDX Digital X-Ray System, a dental intraoral x-ray sensor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance studies of AI/ML-enabled devices.

Therefore, most of the requested information cannot be extracted from this document regarding acceptance criteria and performance studies. This document is a regulatory submission for a traditional medical device (an intraoral x-ray sensor), not an AI/ML device, and thus the structure of its validation is different.

However, based on the information provided, here's what can be stated:

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

This information is not available in the provided 510(k) summary. Acceptance criteria for a device like this would typically involve image quality metrics (e.g., spatial resolution, contrast resolution, signal-to-noise ratio), dose reduction capabilities, and mechanical/electrical safety standards. The document states the device is "substantially equivalent" to a legally marketed predicate device, implying it meets similar performance and safety standards, but no specific criteria or performance data are reported.

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

This information is not available in the provided 510(k) summary regarding a specific performance test set. The submission focuses on device description and indications for use, not a clinical or technical performance study with a distinct test set of images or patients.

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 available in the provided 510(k) summary. Ground truth establishment with experts is usually part of a performance study, which is not detailed here.

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

This information is not available in the provided 510(k) summary.

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 available in the provided 510(k) summary. The Bio-Ray SDX Digital X-Ray System is described as a device to "collect dental x-ray photos and convert them into electronic data" and is used with "computer imaging software provided by other 3rd parties." It is not an AI-enabled device itself, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its specific submission.

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

This information is not available in the provided 510(k) summary. As it's not an AI-enabled device, a standalone algorithm performance study is not applicable.

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

This information is not available in the provided 510(k) summary.

8. The sample size for the training set:

This information is not available in the provided 510(k) summary. Training sets are relevant for AI/ML models, which this device is not stated to be.

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

This information is not available in the provided 510(k) summary.

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The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.

The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Transport Incubator 185A". This document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The letter is a regulatory approval document confirming substantial equivalence to a predicate device, not a performance study report.

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The plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6AI - 4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, KLS and W.L. Lorenz.

This document is a 510(k) summary for the Bioplate Fixation System, which is a rigid bone plating system for craniomaxillofacial surgery.

Based on the provided text, the device is not an AI/ML powered device, nor does it seem to be an imaging or diagnostic device. Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert involvement, MRMC studies, standalone performance), and training set details are not applicable to this submission.

The 510(k) summary only states:

• The device is made of commercially pure titanium and titanium 6AI - 4V ELI alloy.
• These materials have been implanted safely for many years and are recognized as acceptable for implantation through device classification (e.g., 21 CFR sections 888.3030).
• The plates are "substantially equivalent in construction and design" to predicate devices manufactured by Howmedica, Medicon, KLS, and W.L. Lorenz.

The FDA's letter confirms substantial equivalence to pre-amendment devices, subject to general controls and GMP regulations. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with specific performance metrics against acceptance criteria in the way a novel diagnostic or AI device might.

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The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal I.D. of 1.25 mm (.050%) when combined with nonabsorbable sutures in a surgical application.

Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Shunt Connector

The provided text is a 510(k) premarket notification letter from the FDA for a device called "The Bioplate Shunt Connector." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement for proving the device meets acceptance criteria.

The information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typically found in a clinical study report or a more detailed technical submission than an FDA 510(k) clearance letter.

Therefore, I cannot provide a response to your request based on the given input text.

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The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.

The provided text is a 510(k) premarket notification letter from the FDA to Biomedics, Incorporated, regarding their "Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This document does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device does not need to submit clinical trial data to demonstrate safety and effectiveness for this review pathway. Instead, substantial equivalence relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but no new questions of safety and effectiveness and is as safe and effective as the predicate device.

Therefore, I cannot provide the requested information based on the given text.

To be clear:

• Acceptance criteria and reported device performance: Not present.
• Sample size and data provenance for test set: Not applicable, as no study results are provided.
• Number and qualifications of experts for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable (this is a medical device, not an algorithm).
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including: cranial fixation, midface fixation, mandibular fixation, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation, zygomatic fixation. The device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.

The provided document is a 510(k) summary for the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. It declares substantial equivalence to predicate devices but does not contain acceptance criteria or the results of a study proving the device meets specific performance criteria.

The document focuses on:

• Materials: Commercially pure titanium and titanium 6Al-4V ELI alloy, stating they are recognized as acceptable for implantation.
• Substantial Equivalence: Claiming the plates are substantially equivalent in construction and design to predicate devices by Biomedics, Inc., W.L. Lorenz, and Synthes (USA). The screws are also claimed to be substantially equivalent in design and at least equivalent in strength to commercially pure titanium.
• Indications for Use: Listing various applications in craniomaxillofacial surgery, such as treatment of fractures, reconstructive procedures, and fixation of specific facial bones.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because this document does not contain that level of detail. The FDA's 510(k) clearance process for this type of device typically relies on demonstrating substantial equivalence to existing devices rather than requiring new, full-scale clinical trials with extensive acceptance criteria and detailed performance studies like those seen for novel, high-risk devices or software algorithms.

In summary, the provided document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

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Not Found

The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years.

This document (K961976) is a 510(k) premarket notification for a medical device called the "Bioplate Fixation System." It's focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial would for a diagnostic or AI-driven device.

Therefore, most of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not applicable or cannot be extracted from this document. This 510(k) is a regulatory submission, not a research paper.

Here's a breakdown of why and what can be inferred:

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

• Not Applicable/Cannot be extracted. This document does not present acceptance criteria for performance metrics (like accuracy, sensitivity, specificity) because it's a fixation system, not a diagnostic tool. Its "performance" is primarily about material biocompatibility, mechanical strength, and design equivalence to existing, legally marketed 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/Cannot be extracted. This 510(k) does not describe a "test set" in the context of clinical or diagnostic performance. The substantial equivalence argument relies on material composition and design similarity to predicate devices, not on a clinical "test set" of patients or data.

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/Cannot be extracted. "Ground truth" in this context (fixation system) would relate to things like "does it adequately hold bone fragments together?" This is not assessed through expert consensus on a dataset in a 510(k) for this type of device. The "truth" is established through engineering specifications and the history of safe use of similar materials and designs.

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

• Not Applicable/Cannot be extracted. No clinical "test set" or adjudication process 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/Cannot be extracted. This is a fixation system, not an AI-driven diagnostic device. MRMC studies are completely irrelevant in this context.

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

• Not Applicable/Cannot be extracted. This is a physical medical device, not an algorithm.

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

• Not Applicable/Cannot be extracted. The "ground truth" for this type of device relates to its fundamental properties:
  • Material Composition: Commercially pure titanium and titanium 6A1-4V ELI alloy. The "truth" here is that these materials are known, accepted, and described in device classifications (e.g., 21 CFR 888.3030) as safe for implantation.
  • Design Equivalence: The plates and screws are "substantially equivalent in construction and design" to predicate devices manufactured by Howmedica, Medicon, Inc., KLS, and W.L. Lorenz. The "ground truth" is that these predicate devices are already legally marketed and have a history of safe and effective use.

8. The sample size for the training set

• Not Applicable/Cannot be extracted. There is no "training set" for this type of device.

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

• Not Applicable/Cannot be extracted. No training set.

Summary derived from the provided text for K961976:

This 510(k) submission establishes the safety and effectiveness of the Bioplate Fixation System by demonstrating substantial equivalence to predicate devices. The key arguments are:

• Materials: Manufactured from commercially pure titanium and titanium 6A1-4V ELI alloy, which are recognized as safe and acceptable for implantation (referencing 21 CFR 888.3030).
• Design: Plates and screws are substantially equivalent in construction and design to predicate devices from Howmedica, Medicon, Inc., KLS, and W.L. Lorenz.

The "acceptance criteria" in this context are implicitly met by demonstrating that the device is made of safe materials and its design is equivalent to already cleared devices, thereby implying it performs at least as safely and effectively as those predicate devices. No new clinical performance data in the typical sense is presented or required for this type of 510(k).

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