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Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

• Acceptance Criteria (implied standards compliance):

  • Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
  • Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
  • Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
  • Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.

• Reported Device Performance (bench tests):

  • USP/EP diameter: Tested, found equivalent to predicate.
  • USP needle attachment: Tested, found equivalent to predicate.
  • USP tensile strength: Tested, found equivalent to predicate.
  • Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
  • Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

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SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.

Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document highlights the following non-clinical performance criteria and testing for the sutures:

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

2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.

4. Adjudication method for the test set: Not applicable as this is a non-AI/ML device.

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 as this is a non-AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.

7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).

8. The sample size for the training set: Not applicable as this is a non-AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.

The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the predicate devices.

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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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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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Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture. The device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Non-absorbable Surgical Silk Suture. This type of device is a physical medical product, not an AI/software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it applies to AI/software performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, etc.) is not applicable here.

Instead, for a physical medical device like a surgical suture, the "acceptance criteria" and "proof" relate to:

• Material properties: Does the suture material meet established standards (e.g., USP requirements for diameter, tensile strength)?
• Biocompatibility: Is the material safe for use in the human body (e.g., non-toxic, non-irritating, non-hemolytic)?
• Sterilization: Is the device effectively sterilized and free from harmful residuals?
• Packaging integrity: Is the packaging designed to maintain sterility until use?
• Performance: Does the device perform as intended (e.g., needle attachment strength)?

The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance.

Here's a breakdown of the relevant information from the document, reinterpreting "acceptance criteria" for a physical device:

Acceptance Criteria and Device Performance for Non-absorbable Surgical Silk Suture (K232355)

The acceptance criteria for this medical device are based on compliance with various established standards and the demonstration of substantial equivalence to a legally marketed predicate device (K161633, REXSIL). The performance is evidenced by non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The following sections (2-9) are not applicable as they relate to AI/software performance studies, which are not relevant for this physical surgical suture device. The information provided in the document confirms that this is a traditional medical device submission for which clinical trials (and thus clinical data for training/testing or expert adjudication for ground truth) were not required.

2. Sample size used for the test set and the data provenance: Not applicable for this physical device. Testing would involve a statistically significant number of physical samples for each test (e.g., tensile strength, diameter, biocompatibility). Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP) and laboratory measurements by qualified technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is a physical device, not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is adherence to established engineering specifications, material standards, and biological safety standards (e.g., precise diameter measurements, specific tensile strength values, confirmed absence of cytotoxicity, etc.). These are objectively measured in laboratories according to validated test methods.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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

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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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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.

• 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.

• 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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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:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. 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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The BRAUN Silk.expert Mini Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Mini is also indicated for the 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.

Not Found

This document is an FDA 510(k) clearance letter for the Braun Silk.expert Mini, a hair removal device. It primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. The document confirms the device's clearance 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," but it does not elaborate on the specific study details that validated this claim.

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