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Found 31 results
510(k) Data Aggregation
(271 days)
The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.
RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and electrode tip, the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.
- Electrosurgical Unit Main body
- Five different handpieces
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (SILKRO), primarily focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to various safety and performance standards. It mentions non-clinical ex vivo animal testing for histological data but does not present this data as acceptance criteria or a study proving device performance against such criteria. The document explicitly states, "No clinical test was performed."
Therefore, I cannot extract the requested information.
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(30 days)
Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides longterm restoration and augmentation.
Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.
The provided text does not contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria in the context of a clinical performance study with human readers or an AI algorithm. The document is an FDA 510(k) summary for a medical device (Silk Voice, SMI-04) and primarily focuses on demonstrating substantial equivalence to a predicate device (Silk Voice, K180631) through bench testing and shelf-life data.
Therefore, most of the requested information cannot be extracted from this document, specifically points 1, 2, 3, 4, 5, 6, 7, 8, and 9 relate to clinical or AI performance studies which are not described here.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states: "All bench testing passed the acceptance criteria." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not detailed in the summary. For example, for "Particle size and circularity analysis", it's mentioned that it passed, but the acceptance range and the measured value are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The performance testing described is bench testing, not a clinical study on a test set of human 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, as there is no test set involving human data or expert review described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no test set involving human data or ground truth adjudication 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. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No AI algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context would be the design specifications and regulatory requirements for the bench tests.
8. The sample size for the training set
Not applicable. No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI algorithm is mentioned.
Summary of available information related to performance testing:
The device's performance was evaluated through bench testing and shelf-life testing.
- Bench Testing:
- Tests Performed: Particle size and circularity analysis, Rheometry, Extrusion force, HA fragment test, Particle concentration, Residual Crosslinker Content, pH, Endotoxin, Catheter leak test, Catheter tensile strength.
- Outcome: "All bench testing passed the acceptance criteria," demonstrating that the delivery system meets pre-established design input requirements.
- Biocompatibility: Relied on "Biocompatibility test results of the predicate device submitted as part of the original submission (K180631)," which are stated to "continue to support that Silk Voice® meets the requirements of ISO 10993 for its intended use."
- Shelf-Life Testing: Performed to support labeled expiration dating.
- Sterilization Validation: Conducted for steam and EtO sterilization cycles, demonstrating a Sterility Assurance Level (SAL) of 10-6.
The primary purpose of this submission is to demonstrate substantial equivalence to an existing predicate device (Sofregen's Silk Voice K180631), highlighting that a change in silk particle size ($250 \pm 50 \mu m$ in the subject device vs. $380 \pm 46 \mu m$ in the predicate) "does not affect the safety or effectiveness assessment."
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(239 days)
The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.
The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.
The provided text describes the regulatory clearance for the Silk'n Titan AllWays device but does not present specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format typically used for performance claims. Instead, it outlines non-clinical performance testing and a clinical study to demonstrate safety and effectiveness for its intended use, which is the non-invasive treatment of mild to moderate facial wrinkles.
Here's an attempt to extract the information requested, interpreting "acceptance criteria" as general performance goals implied by the clinical study and the "study that proves the device meets the acceptance criteria" as the clinical trial described.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Clinical Study Goals) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Non-invasive treatment of mild to moderate facial wrinkles. | Statistically significant average reduction of 1.39 Fitzpatrick scores comparing baseline to 3-month follow-up (p < 0.001). |
| Improvement in wrinkle severity. | Improvement of at least 1 score according to the Fitzpatrick Wrinkle and Elastosis scale for most patients. |
| Safety acceptable for home use. | No unexpected adverse events detected. Treatment associated with mild to no pain. |
| Device is easy and safe to operate by end-users. | Usability parameters tested indicated the device is easy and safe to operate. Separate Usability Study confirmed labeling comprehension, user operation, and safety under actual use conditions. |
| Skin temperature does not exceed safe values. | Thermal testing in a human volunteer showed worst-case energy and power deposition is not likely to raise skin temperature above safe, acceptable values. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 32 eligible adult women for the clinical study.
- Data Provenance: The clinical study was conducted at a certified clinic in the US. It is a prospective clinical study specifically designed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3 blinded evaluators.
- Qualifications of Experts: The document does not explicitly state the qualifications (e.g., radiologist, dermatologist, years of experience) of the "3 blinded evaluators" directly, but given the context of facial wrinkle assessment in a clinical study for a medical device, it is highly probable they were experienced clinicians or dermatologists.
4. Adjudication method for the test set
- The document implies that the "3 blinded evaluators" independently assessed the Fitzpatrick scores. It states, "...as determined by 3 blinded evaluators." It doesn't specify an adjudication method like 2+1 or 3+1 if there was disagreement, but rather that the result was "determined by" them cumulatively.
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 comparative effectiveness study was done involving AI assistance. This device is a direct treatment device (RF energy and LED light), not an AI diagnostic or assistance tool for human readers. The clinical study evaluated the direct effect of the device on wrinkle reduction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for direct treatment, not an algorithm. The clinical study assessed the device's performance standalone in human subjects.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Expert assessment/consensus: The reduction in Fitzpatrick scores and improvement based on the Fitzpatrick Wrinkle and Elastosis scale were determined by "3 blinded evaluators." This constitutes expert assessment, likely aiming for consensus or an average.
8. The sample size for the training set
- Not applicable. This device is a direct treatment device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
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(311 days)
The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes) The indications for use for the SILKPRO-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block , which is used to cool the skin tissue during treatment.
The provided text is a 510(k) premarket notification for a medical device, specifically a laser system for hair removal. It aims to demonstrate that the new device, SILKPRO Titanium Diode Laser System, is substantially equivalent to a legally marketed predicate device, the Soprano Titanium.
However, the provided document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and safety/performance verification through non-clinical testing (e.g., electrical safety, software validation, biocompatibility).
The text does not mention:
- Any AI/ML components or algorithms in the device.
- Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML validation.
- Test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot populate the requested table or sections related to AI/ML device validation. The information in the prompt is specific to an AI/ML system's evaluation, which is not described in the provided FDA document.
To directly answer your request based on the provided text, the document does not present the type of information needed to fill out the table and study description you've requested because the device (SILKPRO Titanium Diode Laser System) is a traditional laser device, not an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and intended use of the proposed device to a predicate device. The "acceptance criteria" are implied by meeting the standards and demonstrating similar safety and performance characteristics to the predicate, as verified through non-clinical tests.
If this were an AI/ML device, the requested information would be crucial. Since it is not, the concept of "acceptance criteria" and "study proving it meets acceptance criteria" for an AI/ML system, as you've defined, is not applicable here.
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(382 days)
The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.
The Silk'n Toothwave is intended for over-the-counter use.
The Silk'n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, radiofrequency toothbrush, an over-thecounter device, intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. The Silk'n Toothwave Device is comprised of the handheld, brush head and recharging units. The device utilizes radio frequency (RF) energy and vibration.
The Silk'n Toothwave is comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.
The Silk'n Toothwave device is operated by a single mode push-button located on the handle/hand piece user interface board and a set of light indicators informing the lay user of the device operation.
The Silk'n Toothwave device is designed as a rechargeable handheld electrical toothbrush comprised of the charging base unit and a rechargeable power handheld unit. The chargeable base unit is galvanically isolated from the handheld unit. The Silk'n ToothWave Device is electrically safe in accordance with medical device electrical safety standards (IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-11).
The Silk'n ToothWave Device utilizes vibration and low power RF energy technologies. The action of the brush head has a vibration frequency up to 400Hz. The RF generator generates conductive RF energy at 3 MHz, with a maximal output power of 3W.
The handle or hand piece brush head is designed as a medium oval brush head and features an arrangement of bristles surrounding two low profile hidden RF electrodes and a silicon barrier located in-between the two electrodes. The handle or hand piece is equipped with an ON/OFF switch and indicator panel that indicates the device status (RF activation, vibration level, charging, or error).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n Toothwave device, structured according to your request.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It references past studies but does not detail the specific acceptance criteria and their direct fulfillment in the same way a full study report might. Therefore, some information requested (like specific numerical acceptance criteria for plaque/gingivitis reduction or the exact methodology for establishing ground truth for training data) is not explicitly present in this summary.
Acceptance Criteria and Reported Device Performance
The document describes the intended use of the Silk'n Toothwave device as promoting good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The primary clinical study mentioned in this 510(k) pertains to the reduction of calculus.
| Acceptance Criteria (Implied by Intended Use / Study Focus) | Reported Device Performance (Primary Clinical Study) |
|---|---|
| Reduction of dental plaque | Not explicitly quantified in this 510(k) document |
| Prevention and treatment of gingivitis | Not explicitly quantified in this 510(k) document |
| Reduction of calculus (tested in supplemental study) | Statistical significance demonstrated in calculus reduction: - Control group (n=45): 7.7% reduction at 6 weeks, 11.26% at 12 weeks - Test group (ToothWave, n=42): 2.6% reduction at 6 weeks, -1.47% at 12 weeks (Note: The negative value for the test group at 12 weeks (-1.47%) might indicate a slight increase in calculus from baseline at 12 weeks, or more likely, represents a statistically insignificant change or an average that started in reduction but then didn't continue, while still being statistically significant compared to the control). |
Study Details
The provided 510(k) references several studies, primarily performed for a previous DeNovo application (DEN190039). The current submission includes an additional study specifically on calculus reduction.
2. Sample size used for the test set and the data provenance
-
Calculus Reduction Study (additional study in this 510(k)):
- Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
- ToothWave group (test group): n=42
- Control group: n=45
- Data Provenance: Salus Research Centre, IN, USA. Prospective.
- Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
-
Previous Studies (submitted in DEN190039 for plaque/gingivitis):
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document, but implied to be prospective based on the description of "single-blinded, double arm randomized prospective study" and "additional self-selection study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Calculus Reduction Study: The study was conducted by Kim (RDH, PHD) and Jeff Milleman (DDS, MPA). These are likely the experts who established the ground truth (e.g., conducted the Volpe-Manhold Index (V-MI) examinations). The exact number of examiners used for each subject is not specified (e.g., if both examined each subject or if one was primary).
- Qualifications: RDH (Registered Dental Hygienist), PHD, DDS (Doctor of Dental Surgery), MPA (Master of Public Administration).
- Previous Studies: Not specified in this document.
4. Adjudication method for the test set
- Calculus Reduction Study: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the V-MI examinations performed by the named experts.
- Previous Studies: Not specified in this document.
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, an MRMC comparative effectiveness study was not done. This device is a powered toothbrush, not an AI diagnostic or assistance system for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (a toothbrush) that relies on direct human-in-the-loop operation. It is not an algorithm evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Calculus Reduction Study: Expert clinical assessment using the Volpe-Manhold Index (V-MI) for calculus measurements. This is a recognized clinical index.
- Previous Studies (Plaque/Gingivitis): Implied to be expert clinical assessment based on the study design (single-blinded, randomized prospective study for plaque and gingivitis). Specific indices are not mentioned in this summary but are standard for such studies.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to the device development leading to its final design, which is not quantified in terms of a sample size.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm to establish ground truth for. The development of the device would involve engineering, safety testing, and pre-clinical studies, but not a "ground truth" for a training set in the way you're asking.
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(507 days)
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.
The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.
Specifically, the document lists:
- Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
- Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
- Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
- Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.
Therefore, I cannot provide the requested information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.
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(244 days)
Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified, silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides the long term restoration and augmentation.
Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.
Based on the provided text, the device in question is Silk Voice®, a vocal fold medialization system. The document is a 510(k) premarket notification of intent to market, and as such, it focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria in an independent clinical study that would be typical for an AI/ML device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for an algorithm) are not applicable to this type of medical device clearance or the information provided. The "acceptance criteria" here are primarily around demonstrating substantial equivalence through non-clinical testing and comparison to the predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity for an AI algorithm. Instead, they are based on demonstrating that the device's characteristics and performance are comparable to the predicate device, and that it meets established safety standards.
| Acceptance Criterion (Based on Substantial Equivalence & Safety) | Reported Device Performance (for Silk Voice®) | Comparison to Predicate (Radiesse Laryngeal Implant K070090) |
|---|---|---|
| Intended Use: Vocal fold augmentation | Vocal fold augmentation | Same |
| Indication for Use: Vocal fold medialization and insufficiency improved by soft tissue bulking agent; augments vocal fold size for improved phonation; urgent indication for serious aspiration difficulties. | Matches predicate's indications. | Same |
| Intended User: ENT Specialists | ENT Specialists | Same |
| Composition: Particle component in aqueous gel carrier | Silk particles suspended in cross-linked HA; 30-40% particle by volume | Similar (Predicate: CaHA particles in CMC; 30-40% by volume) - Functionally equivalent. |
| Particle component dimensions: (for comparison to predicate) | 380 ± 46 um in diameter; 30-40% by volume | Similar (Predicate: 35 ± 10 um in diameter; 30-40% by volume) - While sizes differ, the document states "Functionally, the composition of both Silk Voice® and the predicate are equivalent." |
| Sterility: SAL 10-6 | Provided sterile, SAL 10-6 | Same |
| How supplied: Prefilled syringe | Prefilled syringe | Same |
| Delivery: Injection | Injection | Same |
| Implant duration: Long-term (>6 mo) | Long-term (>6 mo) | Same |
| Biocompatibility: Tested in accordance with ISO 10993-1 | Tested in accordance with ISO 10993-1. Meets requirements for intended use for various tests (Subchronic Systemic Toxicity, Mouse Micronucleus, Gene mutation (AMES) assay, Intramuscular Implantation, Intracutaneous Reactivity, Sensitization, Pyrogenicity, Acute Systemic Toxicity, Cytotoxicity) for both syringe and accessory catheter. | Same standard applied |
| Syringe Leachables/Extractables: Compliance with ISO 10993-17 and 10993-18; Margin of safety > 1000. | Evaluated for leachables/extractables. Margin of safety determined to be > 1000 for adult males and females. | (No direct comparison to predicate stated, but meets the safety criterion) |
| Shelf Life Testing: Supports labeled expiration dating. | Performed. | (No direct comparison, but meets the criterion) |
| Bench Testing (Delivery System Mechanical Integrity): | Extrusion force testing passed. Catheter peak tensile force testing passed (meets ISO 10555-1:2013). Catheter leak testing passed (no signs of leakage). | (No direct comparison, but meets pre-established design input requirements) |
| Animal Study - Local Tissue Response & Migration: Comparable tissue responses (inflammation, neovascularization) and retention of particles. | Comparable tissue responses (inflammatory cell composition and neovascularization at injection site) as predicate. Demonstrated retention of particles at injection site. | Functionally comparable to predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Non-Clinical/Animal Study):
- Animal Model: Canine model.
- Sample Size: n=12 for Silk Voice®; n=12 for the predicate product. (Total 24 animals)
- Data Provenance: Not specified, but likely proprietary laboratory animal studies (prospective for the study duration). Country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable in the traditional sense for this device. Ground truth for the animal study (histology, gross pathology, imaging) would be established by veterinary pathologists or other trained personnel, but the specific number or their detailed qualifications are not provided in this summary. This is not an AI/ML device relying on human expert annotations for performance validation.
4. Adjudication Method for the Test Set
- Not Applicable. This is not an AI/ML evaluation where human expert adjudication of output is needed. For the animal study, the assessment of gross pathology, histopathology, inflammation, and neovascularization would typically follow established veterinary pathology protocols, which may involve multiple evaluators for quality control, but a formal "adjudication method" as used in AI performance evaluation is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance in image interpretation. This device is an injectable medical implant; therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device. "Standalone performance" would refer to an AI's diagnostic accuracy without human intervention. This concept does not apply to an injectable medical device.
7. The Type of Ground Truth Used
- For the non-clinical (pre-clinical) animal study, the "ground truth" for evaluating the tissue response and device retention was established through:
- Gross Pathology: Macroscopic observations of tissues.
- Histopathology: Microscopic examination of tissue samples, including scoring of inflammation and neovascularization.
- Imaging: Incremental imaging performed during the study (specific type not detailed).
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a training set. The "design" of the device is based on materials science and engineering principles, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth establishment for such a set. The development of the Silk Voice® device itself relies on established scientific and engineering principles, and biocompatibility/performance testing data from animal models and bench studies to demonstrate safety and functional equivalency.
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(98 days)
The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes.
The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board.
The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Silk'n MODEL H5003 device, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter and 510(k) summary for the Silk'n MODEL H5003 device primarily rely on demonstrating substantial equivalence to a predicate device, rather than defining novel clinical performance acceptance criteria with specific thresholds for a new clinical indication.
Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration that the device's technical specifications and intended use are similar to a legally marketed predicate device, without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Subject Device) | Predicate Device (Body Control System "4M") Performance |
|---|---|---|
| Intended Use Equivalence: Improvement of muscle tone and firmness, strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not for injured/impaired muscles, therapy, or medical conditions/diseases. | The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. | The Body Control System "4M" is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. |
| Technological Equivalence (Key Parameters): | Output voltage: 30v±2.00v | (Data not available in the provided text for comparison, but implied to be similar enough for substantial equivalence) |
| Output current@500Ω: 60mA±4mA | 64 mA (Max output current @ 500 ohms) | (Data not available) |
| Pulse rate: 40Hz±10Hz | 40±10 Hz (Frequency) | (Data not available) |
| Pulse width: 400usec±50usec | 400±50 usec (Phase duration) | (Data not available) |
| Safety Standard Compliance: | AAMI/ANSI 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11 | AAMI/ANSI 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-4 |
| Electrical Safety Features: Automatic shut-off, safety proximity sensor, system abnormalities check. | Equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact. Automatic shut-off. System abnormalities check (implied by "similar safety features" to predicate). | Incorporate similar safety features, including automatic shut off of the energy source at the end of predetermined treatment time period, system abnormalities check, and safety proximity sensor. |
| Biocompatibility of Skin-Contact Materials: | Conductive fabric electrodes (biocompatible with ISO 10993-5 and ISO 10993-10 requirements). | Adhesive electrodes with hydrophilic gel (implied to be biocompatible). |
| Lack of New Safety/Efficacy Concerns: | "The results of these tests demonstrated that all the device specifications meet the system requirements and do not raise new safety or effectiveness concerns." | Basis for substantial equivalence. |
| Output Waveform (Primary Difference Acknowledged): | Symmetrical biphasic, Rectangular shape | Monophasic, Rectangular shape |
| Power Supply: | 1 rechargeable Li-Ion battery, 3.7 V | 3 batteries, 1.5V |
| User Interface: | Push-button, two operational buttons for EMS level, light indicators (LEDs). | User interface (implied to be similar enough for substantial equivalence), LCD display. |
Summary of the Study Proving Acceptance Criteria:
The provided document describes a Non-Clinical (Bench) Performance Data study to demonstrate that the device performs as expected and meets design requirements. It is not a clinical study to establish new clinical efficacy or safety, but rather to show that the device performs technically as intended and is safe when used according to its design specifications. The primary study presented is for Substantial Equivalence to a predicate device.
Details of the Study:
2. Sample size used for the test set and the data provenance:
- Non-Clinical (Bench) Performance Data: The document does not specify a "sample size" in terms of patients or human subjects, as it was a bench test. It implies multiple units of the Silk'n MODEL H5003 device were tested.
- Data Provenance: The tests were conducted internally ("A set of performance tests were conducted... to demonstrate that the Silk'n MODEL H5003 device performs as expected..."). No country of origin for the data is explicitly stated for the bench tests, but the applicant and contact persons are based in Israel. The study is retrospective in the sense that the testing was performed on the completed device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): This type of information (experts, ground truth, qualifications) is relevant for studies involving human interpretation or subjective assessments, often in clinical or diagnostic contexts. For bench testing of an electrical device against technical specifications and safety standards, the "ground truth" is established by the specifications themselves and the relevant international standards (e.g., IEC 60601 series). Compliance is measured by instrumentation, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: Adjudication methods are used in clinical trials or studies where there is subjective assessment or disagreement among multiple evaluators. For bench testing against objective technical standards, adjudication is not typically employed. The results are based on objective measurements by testing equipment.
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: No MRMC or clinical comparative effectiveness study involving human readers or AI assistance was performed or reported. The device is a "Powered Muscle Stimulator" and the evaluation focuses on its technical safety and performance compared to a predicate device, not on AI-assisted interpretation or diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: The device is a physical electromedical device; it does not feature an algorithm for diagnostic or interpretative purposes in the way an AI medical device would. Its performance is related to its electrical output and safety mechanisms, which were tested in a standalone (algorithm-only) sense, meaning the device itself was tested without human interaction during the measurement process, but this is not analogous to an AI algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" was based on predefined technical specifications and international safety/performance standards (e.g., output voltage, current, pulse rate, pulse width measurements, and compliance with IEC 60601 series). These are objective, measurable parameters.
8. The sample size for the training set:
- N/A: The provided document does not mention a "training set." This term is typically used in the development of machine learning or AI models. The Silk'n MODEL H5003 device is an electrical stimulator, not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A: As there's no mention of a training set, the establishment of ground truth for such a set is not applicable.
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(88 days)
The Silk'n Infinity is an over the counter device intended for the removal of unwanted hair. The Infinity device is also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.
The Silk'n Infinity device is designed as a hand held, home use device, which utilizes Intense Pulsed Light (IPL) for hair removal and galvanic microcurrents for skin stimulation. The device comprises a power adaptor and device applicator. The applicator consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.
This document is a 510(k) summary for the Silk'n Infinity device, which is an over-the-counter device intended for hair removal and facial stimulation. The focus of this document is to demonstrate "substantial equivalence" to predicate devices, rather than to prove performance against specific acceptance criteria for a novel device through a formal study.
Therefore, many of the typical elements of an AI/ML device study described in the prompt (e.g., test set sample size, number of experts, MRMC studies, standalone performance, ground truth establishment) are not applicable or not present in this document.
The document primarily focuses on:
- Bench testing: Verifying output parameters and safety in simulated home-use settings.
- Compliance with recognized standards: Showing the device meets established electrical, mechanical, and safety standards for medical electrical equipment.
- Substantial Equivalence Argument: Comparing the Silk'n Infinity to legally marketed predicate devices (Silk'n Glide for IPL hair removal and Facial Spa for microcurrent facial stimulation) based on similar technology, intended use, and safety features.
Here's an attempt to answer the questions based only on the provided text, acknowledging that many questions relate to performance studies that were not conducted or detailed in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for a device's performance against clinical endpoints like hair reduction efficacy or skin stimulation effectiveness, nor does it provide reported device performance data in that format. Instead, the acceptance is based on:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| IPL Output Performance: Match predicate device (Silk'n Glide) specifications. | "The Silk'n Infinity device, IPL optical output performance specifications are based on the same performance specifications as those of the main predicate, the Silk'n Glide which were already evaluated and well established in K131870 & K141242." Specific values are given for predicate: Light Output Power 3-5 J/cm², Pulse duration 500-800 µsec, Wavelength 475-1200nm. |
| Microcurrent Output Performance: Comply with design requirements and align with reference predicate (Facial Spa). | "The test results demonstrated that the output parameters complied with the device design requirements and were in line with the reference predicate output specifications." Specific values for the device are: Maximal output current 420 μA, Maximal output voltage 210 mv & 840 mv. |
| Safety in Simulated Home Use: Safe for intended use. | "The test results showed that the device was safe for use as intended." |
| Software Validation: Met system requirements. | "The Silk'n Infinity device underwent software validation testing as well as was tested and found to comply with..." "These performance tests demonstrated that the device specifications met the system requirements..." |
| Compliance with Electrical & Mechanical Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 60601-2-10 | "The Silk'n Infinity device has been tested and complies with the following voluntary recognized standards:" (lists all mentioned standards). "The results of the tests demonstrated that all of the device specifications met the system requirements and do not raise new safety or effectiveness concerns." |
| Biocompatibility: Comply with ISO 10993-1. | "All patient contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the "simulated home use settings" safety test, the sample size was eight human volunteers.
- Data Provenance: The document does not explicitly state the country of origin for the volunteers. The study was a "bench test" described as evaluating device safety in a simulated home use setting, implying a prospective test conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "simulated home use settings" test was a safety test, not a performance study requiring human "ground truth" for disease detection or similar tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. The described tests are bench and safety performance tests, not clinical efficacy studies requiring adjudication of outcomes or diagnoses.
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 comparative effectiveness study was done or reported in this document. This device is not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. This device is a direct-use medical device (IPL hair removal and microcurrent stimulation), not an algorithm. Bench tests were performed on the device itself to verify output and safety parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety test on human volunteers, the "ground truth" would be the direct observation of adverse events or lack thereof, relative to device parameters. For the technical specifications, the ground truth is established by engineering measurements against predetermined design requirements and compliance with recognized standards.
8. The sample size for the training set:
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/ML algorithm.
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(173 days)
The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device Name: Silk'n HST
Intended Use: Over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for effectiveness appears to be a statistically significant reduction of at least 1.0 score in the average score of the Fitzpatrick Wrinkle Severity Scale, according to at least 2 out of 3 blinded dermatologists, measured 3 months post-treatment end compared to baseline.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Effectiveness: | |
| Statistically significant reduction of at least 1.0 score in average Fitzpatrick Wrinkle Severity Scale score. | Achieved an average statistically significant reduction of 1.49 ± 0.51 Fitzpatrick scores (p<0.001). |
| Reduction determined by at least 2 out of 3 blinded dermatologists. | Downgrade of at least 1 score seen in: - Reviewer #1: 96.67% (29/30) - Reviewer #2: 90.0% (27/30) - Reviewer #3: 93.33% (28/30) - ≥2 agree: 100% (30/30) |
| Safety: | No unexpected adverse events detected. Treatment associated with no to merely mild pain. |
| Usability / User Satisfaction: | All 30 study participants were (very or somewhat) satisfied with the ease of learning to use the device. 86% (26/30) of patients were satisfied to very satisfied with overall device performance. 97% (29/30) indicated some improvement in wrinkle status. |
| Self-selection and Labeling Comprehension: | 100% success rate in self-selection study (25 subjects). 100% success rate in labeling comprehension test (20/20 patients found it easy to understand instructions). 100% of eligible subjects successfully performed device-related tasks with minimal assistance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Effectiveness Study (Test Set): 30 eligible adults (N=30, completer case analysis).
- Sample Size for Usability/Self-Selection Study (Test Set):
- Self-selection: 25 subjects.
- Usability/Labeling Comprehension: 20 subjects (from the 25, implying 5 were excluded due to contraindications).
- Data Provenance: The clinical study was conducted at a certified clinic in the US. The text does not explicitly state whether it was retrospective or prospective, but the description of the study design ("included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments," "3 months following treatment end") strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 3 blinded dermatologists.
- Qualifications of Experts: They are referred to as "blinded dermatologists," indicating a medical specialization relevant to skin conditions and aesthetic evaluation. No specific experience (e.g., years) is mentioned.
4. Adjudication Method for the Test Set
The effectiveness criterion explicitly states "according to at least 2 out of 3 blinded dermatologists." This indicates a 2/3 majority consensus adjudication method for determining success on the Fitzpatrick scale.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This study focused on the effectiveness of the device itself (AI is not mentioned here as assisting human readers, rather the device is the treatment).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a physical, home-use treatment device (combining RF and LED energies) for wrinkles, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" does not apply in the context of this submission. The performance measured is that of the device's effect on patients.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by expert consensus (at least 2 out of 3 blinded dermatologists) using the Fitzpatrick Wrinkle Severity Scale. User satisfaction and usability were derived from subject questionnaires and observed task performance.
8. The Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning or AI models. This device is a physical energy-based device, not a software algorithm that requires a training set. The clinical study described served as the primary test set for the device's safety and effectiveness.
9. How the Ground Truth for the Training Set was Established
As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was evaluated through a clinical study where outcomes were assessed by blinded dermatologists and participant feedback.
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