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510(k) Data Aggregation
(90 days)
MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.
The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.
The provided text is a 510(k) Premarket Notification from the FDA regarding the MISTI Silicone Implant. This document outlines the manufacturer's claim of substantial equivalence to existing predicate devices, primarily based on material, design, function, and performance data from non-clinical tests.
However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically what these questions relate to for AI/Software as a Medical Device (SaMD).
Therefore, I cannot provide the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) submission.
This 510(k) focuses on demonstrating the physical and biological safety of the MISTI Silicone Implant by comparing its characteristics and performance in non-clinical tests (material properties, biocompatibility, sterilization) to legally marketed predicate devices, rather than on diagnostic accuracy or clinical effectiveness studies in humans with defined acceptance criteria for AI performance.
The "Performance Data (Non-Clinical)" section lists various tests performed, such as:
- Sterilization Validation
- Appearance
- Dimensional inspection
- Extraction
- Hardness (ASTM D2240 (Type A))
- Tensile strength (ASTMD412)
- Elongation (ASTM D412)
- Tear strength (ASTM D624)
- Cytotoxicity (ISO 10993-5)
- Skin Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-23)
- Pyrogen (ISO 10993-11)
- Acute Systemic Toxicity (ISO 10993-11)
- Subchronic Toxicity (ISO 10993-11)
- Implantation (ISO 10993-6)
- Genotoxicity (Ames) (ISO 10993-3)
- Genotoxicity (In vitro) (ISO 10993-3)
These tests are primarily focused on the safety and material properties of the implant, not on evaluating an AI algorithm's diagnostic performance.
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(127 days)
The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.
The provided text is a 510(k) Summary for a medical device (Pre-Formed Silicone Block). This document describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria through performance evaluation.
Therefore, the information required to answer the prompt (acceptance criteria, device performance results, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided text. The document states:
- "No additional testing was provided in this submission in order to demonstrate substantial equivalence."
- "Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence." (This implies that this specific submission did not include new performance studies comparing the device to acceptance criteria, but rather relied on comparisons to previously cleared devices and existing safety/biocompatibility data.)
In summary, the provided FDA 510(k) summary does not contain the information requested about performance studies, acceptance criteria, or their results. It primarily focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics.
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(102 days)
ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour
ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.
ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
This document is a 510(k) summary for the ShiNeo Silicone Implant. It asserts that the device is "identical/substantially equivalent" to a predicate device, the BioSiCar Silicone Implant (K193392).
Because the submission claims identity between the proposed device and the predicate device, it explicitly states:
- No performance data was submitted, and no new testing was provided.
- No acceptance criteria were established or studies conducted to demonstrate performance against such criteria for the ShiNeo Silicone Implant.
Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance simply does not exist within this 510(k) summary, as it wasn't required given the claim of identity. The regulatory strategy relies on showing the new device is the same as an already cleared device, not that it independently meets specific performance metrics through new testing.
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(990 days)
The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.
The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools. Instead, it is an FDA 510(k) clearance letter for a physical medical device, the "Augmenta Penile Implant," which is a silicone implant for cosmetic correction of soft tissue deformities.
The document focuses on demonstrating substantial equivalence to a predicate device (Pre-Formed Penile Silicone Block, K181387) rather than proving performance against specific acceptance criteria for an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device and clearance described in the provided text.
The closest analogue to "acceptance criteria" in this document are the non-clinical performance data listed on page 5, which are primarily related to biocompatibility, material integrity, and sterilization for an implantable device, usually demonstrated through adherence to recognized standards like ISO 10993 and ASTM standards.
Non-Clinical Performance Data (related to material and sterilization safety, not algorithmic performance):
- Biocompatibility Assessments (in accordance with ISO 10993-1):
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Implantation
- Genotoxicity
- Extractables and Leachables
- Toxicology Risk Assessment
- Product and Packaging Integrity Assessments (in accordance with recognized standards):
- Visual integrity
- Seal strength
- Shipping
- Burst test
- Sterilization validation (ISO 111135: 2014)
- EO residual (ISO 10993-7: 2008)
- Image artifact evaluations (F2119-07 (2013))
- ASTM D4169-16
- ASTM F88/F88M-15
- ASTM F1140/F1140M-13
- Conclusion: The claim is that these assessments provide evidence that the Augmenta Penile Implant "performs comparable to the legally marketed predicate device."
In summary, none of the requested information regarding AI/ML device performance and validation can be provided from this document.
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(59 days)
The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
The device in question is the Pre-Formed Penile Silicone Block.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative format for the clinical study. Instead, it describes observed outcomes and improvements. Based on the "Clinical effectiveness" section, we can infer the measures of performance.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (Achieved) |
|---|---|
| Penile Circumference Increase | Increased from 8.5 ± 1.2 cm to 13.4 ± 1.9 cm (56.7% increase, P<.001) |
| Self-confidence and Self-esteem Improvement | 83% of patients noted a 2-category improvement 6-8 weeks postoperatively |
| APPSSI Score Improvement (Long-term) | 72% patients maintained a 2-category improvement upon long-term follow-up (2-6 years, mean 4 years) |
| Patient Satisfaction | 81% of subjects reported "high" or "very high" levels of satisfaction |
| Adverse Events requiring device removal | 3% of patients |
| Impact on Sexual Function | No reports of any changes to sexual function, erections, or ejaculations |
| Most Frequent Postoperative Complications | Seroma (4.8%), Scar formation (4.5%), Infection (3.3%) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Test Set):
- Initial retrospective study included 526 patients.
- 400 patients responded to the request for consent and were included in the analysis.
- Data Provenance: Retrospective study. The country of origin is not explicitly stated, but the submission is from "International Medical Devices, Inc." in Beverly Hills, CA, USA, suggesting the study likely took place in the USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the clinical outcomes. The clinical effectiveness was evaluated via patient-reported outcomes (APPSSI, self-confidence/self-esteem, satisfaction) and objective measurements (penile circumference) taken by clinical staff, and complication rates observed by the surgeons.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the study relies on patient-reported outcomes, objective measurements, and observed complications rather than expert consensus on interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical effectiveness study of the device itself, not an evaluation of an AI system with or without human assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) study was not done. The device is a physical implant, and the study evaluates its clinical performance in human patients. This document does not describe an AI medical device.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's clinical effectiveness was a combination of:
- Objective Measurements: Penile circumference measurements taken before, immediately after, and 30-90 days after surgery.
- Patient-Reported Outcomes: Changes in the Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in patient self-confidence and self-esteem, and patient-reported satisfaction levels.
- Clinical Observations: Incidence of adverse events (seroma, scar formation, infection) and events necessitating device removal, as well as absence of changes to sexual function.
8. Sample Size for the Training Set
The document describes a clinical study evaluating the performance of the device; it does not mention a training set in the context of machine learning or AI. This is a study of a physical medical device.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set or an AI algorithm, this question is not applicable to the provided document.
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(227 days)
BioSiCar Silicone Implant is intended for the augmentation of the nasal and/or chin contour.
BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
The provided text is a 510(k) Summary for the BioSiCar Silicone Implant. This document describes the device and its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical testing. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
The "acceptance criteria" discussed in the document are general requirements for the device's safety and performance related to its physical and biological properties, not performance metrics for an AI/ML algorithm.
Therefore, I cannot provide accurate answers to most of the requested points, as they pertain to AI/ML device validation studies.
However, I can extract the information that is present:
Metalware Technology Corp. BioSiCar Silicone Implant - 510(k) Summary Analysis
1. A table of acceptance criteria and the reported device performance
The document mentions that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use". However, it does not explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values. It only states that the device "meets the requirements".
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements |
| Performance & Shelf life | Met requirements |
| Sterilization verification | Met requirements |
2. Sample sized used for the test set and the data provenance
Not applicable. The tests performed are non-clinical (e.g., material testing, sterilization, shelf-life), not a clinical study with a "test set" of patient data in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is relevant for AI/ML validation where expert review establishes ground truth for image or data interpretation. The BioSiCar Silicone Implant is a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for AI/ML performance evaluation.
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. This device is a physical implant, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical implant.
7. The type of ground truth used
For biocompatibility, performance, and sterilization, the "ground truth" would be established by industry standards (e.g., ISO standards for biocompatibility) and regulatory requirements, rather than expert consensus on medical images or pathology in the context of AI/ML.
8. The sample size for the training set
Not applicable. This is for AI/ML model training.
9. How the ground truth for the training set was established
Not applicable. This is for AI/ML model training.
Summary of what the document does provide:
The document describes the BioSiCar Silicone Implant as "intended for the augmentation or reconstruction of the nasal and/or chin contour." It confirms that "BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use."
It states that non-clinical testing was conducted, including:
- Biocompatibility
- Performance & Shelf life
- Sterilization verification
The conclusion drawn from this non-clinical testing is that "All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device."
Crucially, "No clinical test data was used to support the decision of substantial equivalence," and the substantial equivalence determination is based on the device having "similar intended use, same technology/mechanism of action, same claim of safety and performance, and similar technological specification as the predicate device, SOFTXIL (K171851)." This implies the acceptance criteria for this type of medical device are primarily focused on material properties, biocompatibility, and manufacturing processes, rather than diagnostic accuracy or clinical outcomes demonstrated in patient studies.
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(243 days)
The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
The provided document is a 510(k) summary for the Pre-Formed Penile Silicone Block. It details the device, its intended use, and its substantial equivalence to a predicate device. However, this document describes a medical device (an implantable silicone block), not a software or AI/ML-based device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device performance validation (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.
The document focuses on demonstrating the safety and effectiveness of the physical implant through non-clinical testing, primarily biocompatibility testing and chemical analysis, to show substantial equivalence to a previously cleared predicate device.
Here's how the provided information relates to the typical regulatory submission for this type of device:
- Acceptance Criteria and Device Performance: For a physical implant like this, acceptance criteria would typically involve meeting specific material properties, biocompatibility standards, and demonstrating no new safety or effectiveness concerns compared to a predicate device.
- Reported Device Performance: The document states that testing (Biocompatibility Risk Assessment per ISO 10993-1, Cytotoxicity testing per ISO 10993-5, Extractable/Leachable Chemical Analysis, Toxicological Risk Assessment per ISO 10993-17) was performed and the results "indicate that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate device." This is the essential "performance" claim for this type of device in a 510(k). The detailed numerical results of these tests and their specific acceptance criteria are not provided in this public 510(k) summary but would have been part of the full submission.
In summary, none of the requested points related to AI/ML device validation (points 2-9) can be answered from this document because it pertains to a physical medical implant, not an AI/ML algorithm.
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(268 days)
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations. The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
This document is a 510(k) summary for a medical device called SOFTXIL. It describes that SOFTXIL is a facial silicone implant intended for augmentation or reconstruction of the nasal, malar, and/or chin contour. It is compared to a predicate device, the AART Silicone Carving Block.
Based on the provided text, there is no information about a study that used a test set, ground truth established by experts, or AI performance. The document focuses on non-clinical bench tests and a substantial equivalence discussion to a predicate device.
Here's a breakdown of the available information based on your request, with "Not Provided" for information not found in the text:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Sterilization Validation (ISO11737-1) | Passed (Validation performed) |
| Shelf Life Test (ASTM F 1980): | Passed (Test performed) |
| - Appearance | Passed |
| - Sterility | Passed |
| - Tensile Strength | Passed |
| - Elongation Percentage | Passed |
| - Shore Hardness | Passed |
| - Tearing Strength | Passed |
| - Seal Strength | Passed |
| - Dye Penetration | Passed |
| Biocompatibility Test: | Passed (Tests performed) |
| - ISO 10993-5 (Cytotoxicity) | Passed |
| - ISO 10993-6 (Local Effects After Implantation) | Passed |
| - ISO 10993-10 (Irritation and Skin Sensitization) | Passed |
| - ISO 10993-11 (Systemic Toxicity) | Passed |
| - USP<51> (Antimicrobial Effectiveness) | Passed |
| Performance Tests: | Passed (Tests performed) |
| - Appearance | Passed |
| - Dimensions | Passed |
| - Extractable substances | Passed |
| - Hardness (ASTM F881) | Passed |
| - Tensile Strength (ASTM F881) | Passed |
| - Elongation at Break (ASTM F881) | Passed |
| - Tear Strength (ASTM F881) | Passed |
Note: The document states "The test results of the tests support that the subject device is substantially equivalent to the predicate devices," implying that the device met the acceptance criteria derived from these tests. Specific numerical values for the performance are not provided.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided (The tests mentioned are non-clinical bench tests, not a clinical test set as typically understood for AI or diagnostic devices.)
- Data Provenance: Not Provided. The applicant is BISTOOL from Seoul, Republic of Korea, where the testing would likely have been conducted, but this is not explicitly stated for all tests.
-
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 Provided (This type of expert evaluation for ground truth is not applicable to the non-clinical bench tests described.)
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided (Not applicable to the non-clinical bench tests described.)
-
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 done. This is not a diagnostic device or an AI-assisted device. The document describes a silicone implant and its physical and chemical properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not done. This is not an AI algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical bench tests would be the established scientific and engineering standards and specifications (e.g., ISO, ASTM, USP standards) against which the device's material properties and performance are measured.
-
The sample size for the training set
- Not applicable/Not Provided (There is no "training set" as this is not an AI or machine learning device.)
-
How the ground truth for the training set was established
- Not applicable/Not Provided (There is no "training set" or corresponding ground truth to establish.)
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(134 days)
The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
The provided text pertains to a 510(k) premarket notification for a medical device called the "Pre-Formed Penile Silicone Block." The document describes the device, its intended use, and its equivalence to predicate devices, including summaries of non-clinical and clinical testing. However, it does not explicitly list acceptance criteria in a formal table or report specific performance metrics against such criteria in the way typically expected for an AI/ML device.
Here's an analysis based on the information provided, framed as closely as possible to your request, but with the understanding that this is a medical device submission, not an AI/ML algorithm submission. Therefore, many of your requested points, particularly those related to AI/ML specific studies (MRMC, standalone algorithm performance, training set details), are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as pass/fail thresholds against specific performance metrics in a numbered or tabular format. Instead, it discusses the outcomes of a clinical study demonstrating the risks of the device and comparing them to existing similar devices.
| Performance Metric | Reported Device Performance (N=100 patients) |
|---|---|
| Pain Assessment | Weighted average pain rating: 3.2 (on a 0-10 Comparative Pain Scale). Pain relief experienced on average in 7.2 days. |
| Erosion | 3 cases observed (3% incidence). Occurred on average 8 months post-procedure (min 6 months, max 10 months). 3/3 cases linked to patient non-compliance. |
| Migration | 4 cases observed (4% incidence). Occurred on average 1.5 months post-procedure (min 1 month, max 2 months). 3/4 cases linked to patient non-compliance. |
| Infection | 3 cases observed (3% incidence). Occurred on average 3.5 months post-procedure (min 2.5 months, max 4.5 months). |
| Overall Risk | "Rates of pain, erosion, migration, and infection are low compared to reports of other silicone implants on the market." (Comparative statement, no specific threshold) |
2. Sample size used for the test set and the data provenance
- Sample Size: 100 patients
- Data Provenance: Clinical evidence on 100 patients, without explicit mention of country of origin. The study is prospective, as follow-up data was collected after the surgical procedure at specified time points.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth in this context refers to the clinical outcomes and adverse events observed in patients. It's not explicitly stated how many "experts" established the ground truth in terms of retrospective review or consensus. The data appears to be collected clinically by the "clinic" observation and patient self-reporting (for pain). The "surgeon's discretion" is mentioned for contouring the device, implying a medical professional involved in the procedure itself.
4. Adjudication method for the test set
Not explicitly stated. Clinical observations and patient self-assessment (for pain) are the methods of data collection. It's not specified if multiple independent reviewers or an adjudication committee validated each reported adverse event. The document notes that a clinic observed the adverse events.
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 physical implant, not an AI/ML algorithm. Therefore, no MRMC study, human reader improvement with/without AI, or effect size related to AI assistance would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The ground truth is based on clinical outcomes and adverse events observed in patients following the surgical implantation of the device. This includes:
- Patient-reported pain levels.
- Clinically observed events such as erosion, migration, and infection.
8. The sample size for the training set
Not applicable. This not an AI/ML algorithm requiring a training set. The clinical study of 100 patients serves as the primary evidence for the device's safety and performance in humans.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm mentioned in this document.
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(52 days)
The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Gluteal Implants (Silicone Carving Blocks)
This document is a 510(k) premarket notification letter from the FDA regarding a Gluteal Implant. This type of document, particularly one from 2005, is highly unlikely to contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/ML-based medical devices.
The information provided is primarily an FDA clearance letter for a physical medical device (gluteal implant made of silicone) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested fields are not applicable.
Here's a breakdown based on the provided text, highlighting what is not applicable (N/A):
| Information Requested | Response |
|---|---|
| 1. Table of Acceptance Criteria and Reported Performance | N/A. This document does not contain acceptance criteria for an AI/ML system or reported device performance metrics in that context. It's a clearance letter for a physical implant based on substantial equivalence. |
| 2. Sample size and data provenance for test set | N/A. This is a physical gluteal implant, not an AI/ML device tested with data. The 510(k) clearance is based on substantial equivalence to a predicate device, not on clinical study performance data for an AI algorithm. |
| 3. Number of experts and qualifications for ground truth | N/A. Ground truth establishment by experts is not relevant for a physical implant submission unless it involved an assessment of images for which the implant was used, which is not the case here. The ground truth for device safety and effectiveness is largely based on material properties, design, and clinical use of predicate devices for substantial equivalence. |
| 4. Adjudication method for test set | N/A. Not applicable for a physical implant. |
| 5. MRMC comparative effectiveness study | N/A. This applies to diagnostic devices or those involving human interpretation, not a physical implant. |
| 6. Standalone (algorithm only) performance study | N/A. This is not an algorithm. |
| 7. Type of ground truth used | N/A. While the safety and effectiveness of the implant would be supported by general medical knowledge, material science, and clinical experience with similar implants, the concept of "ground truth" as used in AI/ML performance evaluation does not apply directly. |
| 8. Sample size for the training set | N/A. Not an AI/ML device with a training set. |
| 9. How ground truth for the training set was established | N/A. Not an AI/ML device with training data. |
Summary of the Document's Actual Content:
The document is an FDA 510(k) clearance letter dated November 4, 2005, for a device named "Gluteal Implant" (Trade/Device Name) under the product code MIB (Ear, nose, and throat synthetic polymer material, although the device is for gluteal augmentation, the regulation number 21 CFR 874.3620 typically covers synthetic polymer materials used in ENT, implying a material-based classification rather than anatomical region).
- Indications for Use: The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. They are carvable to allow the surgeon to shape the device.
- Regulatory Status: The device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
- Applicant: Implantech Associates, Inc., submitted the 510(k) (K052504).
- Classification: Class II device.
The information you are seeking about acceptance criteria for an AI/ML device is not present in this physical device clearance letter.
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