Search Results

Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars.

Spectragel is used only on intact skin and is manufactured out of medical grade, biocompatible silicone material.

The provided text is a summary of a 510(k) submission for a medical device called "Spectragel Silicone Gel." It describes the device, its indications for use, and the FDA's "substantially equivalent" determination to pre-amendment devices.

However, this document does not contain any information about a study that assesses the device's performance against acceptance criteria. The acceptance criteria and the study details you've requested are typically found in clinical trial reports or performance validation studies, which are not included in this particular FDA communication.

Therefore, I cannot provide the detailed information about acceptance criteria or a study from the given text. The document is primarily an FDA clearance letter based on substantial equivalence, not a detailed performance study report.

In summary, the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them.

Ask a specific question about this device

The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.

The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.

This document is a 510(k) summary for the "Spectrum Designs Pre-Form Contour Silicone Carving Block Implant." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through clinical or performance studies in the way you've outlined. This document primarily details:

• Submitter's Data: Company contact information.
• Device Name, Classification: "Spectrum Designs Pre-Form Contour Silicone Carving Block," Class II, FDA Code MIB.
• Substantially Equivalent Devices: Lists similar silicone block implants.
• Device Description: Fabricated from solid silicone elastomer with a pre-formed, rounded shape.
• Indications for Use: To be used where a shaped, cut-to-fit implant is desired for augmenting or reconstructing cartilaginous tissue, soft tissue, and bone.
• Contraindications for Use: Presence of infection.
• Warnings, Precautions: Potential complications such as displacement, errors in positioning, tissue necrosis, bone resorption, fibrous tissue encapsulation, infection, neural damage, hematoma, poor wound healing, and patient intolerance.

The FDA's response letter (pages 1 and 2 of the provided text) confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information provided in the 510(k) submission, not on a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested table or information about acceptance criteria, sample sizes, ground truth, or MRMC studies because this document does not contain that type of information.

Ask a specific question about this device

The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.

Here's a breakdown of the acceptance criteria and study information for the Spectrum Designs Anatomical Chin Implant, based on the provided text.

Based on the provided document, the "study" that proves the device meets acceptance criteria is implied through the 510(k) submission process, which relies on demonstrating substantial equivalence to a previously legally marketed predicate device. This is not a traditional clinical study with defined performance metrics, but rather a regulatory pathway demonstrating that the new device is as safe and effective as existing ones.

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a Class II device relying on substantial equivalence, there isn't a table of discrete acceptance criteria with numerical performance targets in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are met by demonstrating the device is:

• As safe and effective as legally marketed predicate devices.
• Has the same intended use as legally marketed predicate devices.
• Has the same technological characteristics as legally marketed predicate devices, or if there are differences, those differences do not raise different questions of safety and effectiveness.

The "reported device performance" is implicitly that the device performs equivalently to its predicates for the stated indications.

Study Information (Based on 510(k) Substantial Equivalence Determination)

Given the nature of the 510(k) summary provided, the following points address the questions in the context of a substantial equivalence determination rather than a specific clinical trial.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of this 510(k) summary. There is no mention of a traditional "test set" from a clinical study. The determination is based on a comparison to predicate devices already on the market.
   • Data Provenance: Not applicable. The submission relies on information about the predicate devices and the physical characteristics/materials of the new device itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth as typically defined in the context of performance studies (e.g., for AI) is not established here. The FDA reviews the submitted documentation and makes a regulatory decision.

3. Adjudication method for the test set:

   • Not applicable. No "test set" and no expert adjudication process described for performance evaluation.

4. 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 physical chin implant, not a diagnostic AI system or a system requiring human interpretation of output.

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

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

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

   • Not applicable in the typical sense. The "ground truth" for a 510(k) determination is the established safety and effectiveness of the predicate devices that already have a market history, coupled with the review of the new device's engineering characteristics, materials, and intended use.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this device.

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

   • Not applicable. No AI model or "training set" for this device.

Ask a specific question about this device

The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.

The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.

This document, K980463 for "Spectrum Designs Curvilinear Chin Implant," is a 510(k) summary from 1998 for a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device already on the market, rather than proving safety and effectiveness through clinical studies. Therefore, the information typically found in modern AI/ML device submissions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and adjudication methods will not be present in this document.

The document primarily focuses on:

• Identifying the submitter and device.
• Classifying the device.
• Identifying substantially equivalent predicate devices.
• Describing the device and its intended use and contraindications.
• Listing warnings and precautions.

No study is described in this document that establishes performance against acceptance criteria. The FDA's decision is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed performance study as would be required for a novel AI/ML device.

Therefore, most of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted, along with explanations for the missing fields:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This document does not establish specific performance acceptance criteria for the "Spectrum Designs Curvilinear Chin Implant" nor does it report device performance against such criteria. The 510(k) process for this type of device in 1998 primarily focused on demonstrating substantial equivalence to a predicate device, rather than novel performance claims from detailed clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set or performance study is described.
Data Provenance: Not applicable. No test set or performance study is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No test set or ground truth establishment is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set or adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a medical implant, not an AI/ML diagnostic or assistive device.
Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done: No. This is a medical implant, not an AI/ML algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. No ground truth is established as no performance study is described. The relevant "truth" for this 510(k) is the existing safety and effectiveness profile of the predicate devices.

8. Sample Size for the Training Set

Sample Size: Not applicable. This document is for a physical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Method: Not applicable. This document is for a physical implant, not an AI/ML algorithm.

Ask a specific question about this device

The Spectrum Designs Bilateral Groove Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

The Spectrum Designs Bilateral Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.

This document is a 510(k) Pre-Market Notification summary for a medical device, specifically the Spectrum Designs Bilateral Groove Chin Implant. It is not an AI/ML device, and therefore the majority of the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from the provided text.

The document discusses the device's description, indications for use, contraindications, and potential warnings/precautions. It then details the FDA's decision regarding substantial equivalence to predicate devices. There is no mention of an algorithm, AI, or any performance study based on quantitative metrics typically associated with AI/ML device submissions.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and acceptance criteria. The provided text does not contain that type of information.

Ask a specific question about this device

The Spectrum Designs Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

The Spectrum Designs Concave Back Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.

The provided document focuses on the 510(k) summary for the "Spectrum Designs Concave Back Chin Implant" and the FDA's clearance letter. This type of submission, particularly for a Class II device like a chin implant in 1998, typically relies on substantial equivalence to a predicate device rather than extensive new clinical trials with detailed performance acceptance criteria and study designs in the way that, for example, a novel AI diagnostic device would.

Therefore, the information requested in your prompt (especially regarding AI-specific questions like MRMC studies, standalone performance, training sets, and ground truth establishment for AI models) is not applicable to this document. This document describes a physical medical implant device, not an AI or software-as-a-medical-device (SaMD).

Here's an analysis based on the information provided, recognizing the nature of the device:

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

The document does not explicitly present a table of quantitative acceptance criteria or detailed performance results in the way one would for a diagnostic or AI device. For a physical implant like this, "acceptance criteria" are generally met by demonstrating:

• Substantial Equivalence: The primary "acceptance criterion" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• Biocompatibility: Implied by the use of medical-grade silicone and historical use of similar predicate devices.
• Manufacturing Quality: Assumed by compliance with GMP regulations (Quality System Regulation - 21 CFR Part 820).
• Intended Use: The indications for use match or are comparable to the predicate.

Reported Device Performance (based on substantial equivalence):

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 applicable as there is no "test set" in the context of clinical trial data or performance evaluation for a software/AI device. The clearance is based on substantial equivalence to a predicate device, material properties, and intended use, not on a specific clinical study with a detailed test set described in this summary.

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 is not applicable as there was no test set requiring expert ground truth for this type of device and submission.

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

This is not applicable as there was no test set requiring 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

This is not applicable. This is a physical implant, not an AI or diagnostic device.

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

This is not applicable. This is a physical implant, not an AI or diagnostic device.

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

For this type of device, the "ground truth" for safety and effectiveness is primarily based on:

• Historical performance of predicate devices: The FDA's assessment relies on the established safety and efficacy profile of the "McGhan Medical Corp. Concave Back Chin Implant."
• Material properties: The use of "medical-grade solid silicone elastomer" with a known history of safe implantation.
• General clinical understanding of chin augmentation: The medical community's knowledge of the indications, contraindications, and potential complications of such procedures.

8. The sample size for the training set

This is not applicable as there is no training set for an AI model.

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

This is not applicable as there is no training set for an AI model.

Ask a specific question about this device

The Spectrum Designs Anterior Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

The Spectrum Designs Anterior Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.

This submission is a 510(k) premarket notification for a medical device, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device already on the market. It does not contain acceptance criteria or a study proving the device meets those criteria in the way a clinical trial or performance study would for a novel device or software.

Here's a breakdown based on the provided text, and where certain information is likely not applicable (N/A) for a 510(k) for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) for an implant like this, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This often involves comparing technological characteristics, materials, and intended use. There isn't typically a performance study with numerical metrics like sensitivity/specificity as would be seen for a diagnostic AI device.

2. Sample Size Used for the Test Set and Data Provenance

This information is N/A. This document describes a 510(k) submission for a physical medical implant (a chin implant). It does not involve a "test set" in the context of an algorithm or diagnostic device. The evaluation for substantial equivalence would have been based on specifications, biocompatibility data (if new materials), and comparison to existing predicate devices, not algorithm performance on a dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is N/A. See point 2. There is no "test set" or "ground truth" to be established by experts in the context of an algorithm's performance for this type of device submission.

4. Adjudication Method for the Test Set

This information is N/A. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

This information is N/A. This is a physical implant, not an AI or diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

This information is N/A for an algorithm's "ground truth." For a physical implant, the "truth" is its ability to perform its intended function safely and effectively, which is generally established through material testing, biocompatibility studies (if applicable), mechanical testing, and clinical history of substantially equivalent predicate devices. This document doesn't detail specific "ground truth" methods beyond the general regulatory requirement of substantial equivalence.

8. The Sample Size for the Training Set

This information is N/A. This is not an AI/algorithm-based device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

This information is N/A. This is not an AI/algorithm-based device, so there is no training set or ground truth establishment for such a set.

Ask a specific question about this device

The Spectrum Designs Symmetrical Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.

Spectrum Designs Symmetrical Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.

The provided document, K980138, for the Spectrum Designs Symmetrical Chin Implant is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance as it would for a novel device or a device requiring significant clinical validation. This 510(k) relies on the established safety and effectiveness of its predicate device, the Spectrum Designs Meniscus Chin Implant.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Details of a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm-only) performance data.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document primarily states:

• Device Name: Spectrum Designs Symmetrical Chin Implant
• Intended Use: To augment or reconstruct the mandibular or chin area of the face.
• Demonstration of Safety and Effectiveness: Through substantial equivalence to predicate devices (specifically, the Spectrum Designs Meniscus Chin Implant). This means that the device is considered safe and effective because it is similar in design, materials, and intended use to a device already legally marketed.
• Material: Solid silicone elastomer.

The 510(k) process typically doesn't require extensive new clinical studies if substantial equivalence can be demonstrated. Instead, it relies on comparisons to legally marketed predicate devices, and adherence to general controls (like Good Manufacturing Practices) for safety and effectiveness.

Ask a specific question about this device

The Spectrum Designs Cleft Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.

The Spectrum Designs Cleft Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.

This K980461 document is a 510(k) summary for the Spectrum Designs Cleft Chin Implant. It is important to note that this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document serves as a premarket notification for a Class II medical device, establishing substantial equivalence to previously marketed devices. It outlines:

• Submitter's Data: Company and contact information.
• Device Name, Classification: "Spectrum Designs Cleft Chin Implant," Class II, Product Code 79FWP, 21 CFR 879.3550.
• Identification of Substantially Equivalent Devices: Refers to the same device by name.
• Device Description: Made from solid silicone elastomer, implanted in the mandibular region.
• Indications for Use: To augment or reconstruct the mandibular or chin area of the face.
• Contraindications for Use: Presence of infection, particularly in the implant region.
• Warnings, Precautions: Potential complications (displacement, errors in positioning, tissue necrosis, bone resorption, fibrous encapsulation, infection, neural damage, hematoma, poor wound healing, foreign body intolerance).

The FDA's response letter (pages 1-2) confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This determination is based on the device conforming to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration, and compliance with the Quality System Regulation (QS) for Medical Devices.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets acceptance criteria because this information is not present in the provided text. The 510(k) process for this device type typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness against explicit performance acceptance criteria in the manner that might be seen for novel high-risk devices or software.

Ask a specific question about this device

The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.

Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

The provided text is a 510(k) summary for the "Spectrum Designs Profile Malar Implant". It describes the device, its indications for use, and identifies substantially equivalent devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot populate the table or answer the questions as the information is not present in the provided text. The document primarily focuses on the regulatory submission process and the characteristics of the device itself, not on performance studies or acceptance criteria.

Missing Information:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are mentioned.
• Sample size and data provenance: No study details are provided, so sample size and data provenance are unknown.
• Number of experts and qualifications: No study details are provided, so expert information is unknown.
• Adjudication method: No study details are provided, so adjudication method is unknown.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: This is a physical implant, not an algorithm, so this question is not applicable.
• Type of ground truth: No study details are provided, so ground truth type is unknown.
• Training set sample size: No study details are provided, so training set information is unknown.
• How ground truth for training set was established: No study details are provided, so training set ground truth establishment is unknown.

Ask a specific question about this device