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For Plastic and Reconstructive Surgery* * This product is available by prescription only.

Softform® Implant Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications

{
"1. A table of acceptance criteria and the reported device performance": "The provided text is an FDA 510(k) clearance letter and an 'Indications for Use' page. It does not contain information about specific acceptance criteria or detailed device performance metrics. Its purpose is to declare substantial equivalence to a predicate device and outline the approved indications for use.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided document does not contain information about a test set sample size or data provenance. This type of detail is typically found in the 510(k) submission itself, not in the clearance letter or indications for use.",
"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)": "The provided document does not contain information about experts used to establish ground truth or their qualifications. This is not typically part of an FDA clearance letter.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The provided document does not contain information about an adjudication method for a test set. This detail would be found in the device's validation study, not in the regulatory clearance.",
"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": "The provided document does not contain information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human-AI collaboration. This type of study is more common for diagnostic AI tools, which doesn't seem to be the primary function of the 'Softform® Implant' mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The provided document does not contain information about a standalone algorithm performance study. The device, 'Softform® Implant', is described as a 'Soft Tissue Augmentation Tube with Insertion Tool', suggesting it's a physical implant and not an algorithm-based device requiring standalone performance evaluation.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The provided document does not contain information about the type of ground truth used. As a medical implant, 'ground truth' for its safety and effectiveness would likely come from pre-clinical testing, clinical trials, and material properties, rather than expert consensus on image interpretation or pathology in the context of an algorithm.",
"8. The sample size for the training set": "The provided document does not contain information about a training set sample size. Given the nature of the device ('Softform® Implant' - a soft tissue augmentation tube), it is highly unlikely that an AI training set would be relevant or discussed in its regulatory clearance.",
"9. How the ground truth for the training set was established": "The provided document does not contain information about how ground truth for a training set was established. As noted above, this device does not appear to be an AI/algorithm-based device for which a training set and its associated ground truth would be relevant."
}

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For Plastic and Reconstructive Surgery*
Prescription Use (Per 21 CFR 801.109)

• This product is available by prescription only.

SoftForm™ Implant

I apologize, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for a device called "SoftForm™ Implant." It does not include acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device to be substantially equivalent to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tru-Pulse CO2 Surgical Laser System:

Based on the provided K970804 510(k) Summary, no specific acceptance criteria or study demonstrating device performance against those criteria are presented.

The submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. In this type of submission, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove performance against specific acceptance criteria through a dedicated study.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

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

Explanation: The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no specific performance metrics or acceptance thresholds were established or measured for this submission. The basis for clearance is substantial equivalence to 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)

• Sample Size (Test Set): Not applicable, as no dedicated performance study using a test set was conducted for this 510(k) submission.
• Data Provenance: Not applicable.

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, as no dedicated performance study with ground truth establishment was conducted.

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

• Not applicable, as no dedicated performance study with adjudication was conducted.

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 MRMC study was done. The device in question is a surgical laser, not an AI-assisted diagnostic tool for human readers.

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

• A standalone performance study was not done. The device is a physical surgical laser, not an algorithm.

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

• Not applicable, as no dedicated performance study with ground truth was established for this submission.

8. The sample size for the training set

• Not applicable, as this is a physical medical device (surgical laser), not a machine learning algorithm that requires a training set.

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

• Not applicable, as this is a physical medical device (surgical laser).

Summary of the 510(k) Submission:

The K970804 submission for the Tru-Pulse™ CO2 Surgical Laser relies entirely on substantial equivalence to an existing predicate device, the UltraPulse® Pulsed CO2 Laser manufactured by Coherent.

• Predicate Device: UltraPulse® Pulsed CO2 Laser manufactured by Coherent.
• Basis for Equivalence: The intended use of the Tru-Pulse™ is stated as "the same or similar" to the predicate device for various clinical applications (dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery).
• Performance Data: Crucially, the document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This signifies that the substantial equivalence argument was not supported by new performance studies specific to the Tru-Pulse™ device demonstrating its performance against predefined criteria. Instead, it likely relied on the established safety and effectiveness of the predicate device and the similarity of the new device's design and intended use.

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Ask a specific question about this device

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Ask a specific question about this device