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510(k) Data Aggregation
(86 days)
The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
Phasor LEGACY drill is indicated for drilling of cranial bone by licensed and credentialed medical professionals. The LEGACY drill is manually powered by rotating the handle in a clockwise manner, and is a standalone drill driver without bits or any other items included. It is compatible via an AO quick-connect mechanism with similar AO-interface drill bits, ≤ 6.35 mm diameter and ≤ 70 mm usable length (protruding from the housing). The device is gamma-sterilized and composed of plastic housing with stainless steel shaft.
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(29 days)
The Legacy® IPC is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital settings.
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The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a medical device called LEGACY® IPC. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given input.
The input primarily details:
- The FDA's decision to deem the device substantially equivalent to legally marketed predicate devices.
- The regulatory classification (Class II) and product code (JOW: Compressible limb sleeve).
- General warnings and instructions regarding FDA regulations and compliance.
- The intended uses of the LEGACY® IPC device for prophylaxis of Deep Vein Thrombosis (DVT), stimulating circulation, preventing venous stasis and cutaneous ulcers, and reducing edema and compartmental pressures.
- Confirmation that it is a prescription device for both home and hospital settings.
To provide the requested information, you would need to provide a document that contains the results of performance studies for the LEGACY® IPC device, typically found in a Section 510(k) summary or a detailed clinical/pre-clinical study report.
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Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- . Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
- . Fixture-mounts as an abutment for narrow (3.2mmD) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
- Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments.
| Manufacturer | Abutment Line | Platform Diameter |
|---|---|---|
| Implant Direct | Legacy | 3.0mm, 3.5mm, 4.5mm, 5.7mm |
The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.
The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.
The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.
The provided document is a 510(k) premarket notification from the FDA for dental implants. It details the device description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.
The performance data presented in the document solely pertains to physical and biological properties of the dental implants, such as fatigue testing, biocompatibility, surface area and bone-to-implant contact analysis, pull-out testing, insertion torque testing, sterilization validation, endotoxin testing, shelf-life validation, and distribution validation.
Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission for traditional dental implants.
The document explicitly states on page 7: "No animal or clinical studies were performed in support of this 510(k) notice." This further confirms the absence of the type of studies implied by your questions, which are typically found in submissions for diagnostic or AI-powered devices.
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(115 days)
The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are subsequently tinted to achieve different colors using permanently listed color additives that conform to 21 CFR Part 73.3121. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Black 5, Reactive yellow 15, Reactive orange 78, Reactive red 180.
The Legacy (ocufilcon D) Performance-Tinted Contact Lenses are designed to aid visual performance in athletic settings. Legacy (ocufilcon D) Performance Tinted Contact Lenses enhance contrast in a wide range of outdoor light conditions. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280mm - 315nm), and >50% in the UVA range (316nm - 380nm).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations.
The Legacy (Ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses underwent a series of non-clinical tests to demonstrate their safety and effectiveness. Clinical testing was not required as the performance of ocufilcon D materials has been previously established.
1. Table of Acceptance Criteria and Reported Device Performance:
The following table summarizes the performance data for the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, compared against established standards or general expectations for contact lenses.
| Parameter | Acceptance Criteria (or Standard) | Reported Device Performance |
|---|---|---|
| Toxicology | ||
| In-Vitro Cytotoxicity | Non-toxic (in accordance with ISO 10993-5) | Non-toxic |
| Systemic Toxicity | Non-toxic (meets ISO 10993-11 requirements for systemic injection) | Non-toxic |
| Acute Ocular Irritation | No ocular irritation (in accordance with ISO 10993-10) | No ocular irritation |
| Compatibility | ||
| Solution Compatibility | Compatible with chemical disinfection systems currently marketed for soft (hydrophilic) contact lenses | Compatible with chemical disinfection systems |
| Shelf Life | Stable, sterile, and package integrity maintained over labeled expiration date | Stability, sterility, and package integrity maintained over labeled expiration date |
| Physicochemical & Mechanical Properties | Consistent with predicate device and established standards (e.g., ANSI Z80.20) | Consistent with predicate device and established standards |
| Chord Diameter | ±0.20 mm | Meets tolerance (range: 11.00 mm to 15.00 mm) |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | Meets tolerance (range: 0.05 mm to 0.15 mm) |
| Base Curve | ±0.20 mm | Meets tolerance (range: 7.00 mm to 10.0 mm) |
| Back Vertex Power (F'v) | When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D | Meets tolerance (range: +20.00D to -20.00D) |
| Cylinder Power (F'c) | When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤ 4.00 D → ±0.37 D | Meets tolerance (range: -0.25D to -4.00D) |
| Cylinder Axis | When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D → ± 5° | Meets tolerance (range: 10° to 180°) |
| Multifocal Add Power | ±0.37 D | Meets tolerance (range: +0.25D to +4.00D) |
| Surface Appearance | Lenses should be clear with no surface defect | Clear with no surface defect |
| Oxygen Permeability (x 10⁻¹¹ (cm²/sec)(mlO2)/(ml x mmHg)) | ±20% of 19.6 | 19.6 |
| Light Transmission - Tinted (@ 380-780nm) | > 38% | > 38% (reported with ±5% tolerance) |
| Ultraviolet Radiation Transmittance (TUVB: 280-315 nm; TUVA: 316-380 nm) | < 5 % TUVB; < 50 % TUVA (Specifically: < 0.05Tv TUVB; < 0.50Tv TUVA) | < 5 % TUVB; < 50 % TUVA |
| Water Content | ±2% of 55% | 55% |
| Refractive Index (hydrated) | ±0.005 of 1.410 | 1.410 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a specific sample size for each non-clinical test. However, it indicates that "A series of preclinical testing was performed." The provenance for the non-clinical toxicology tests is that they were conducted "in accordance with the GLP regulation." The data is thus scientifically valid under 21 CFR 860.7. No specific country of origin is mentioned for the test data, beyond the general adherence to international standards (ISO). The nature of the testing is non-clinical (laboratory-based), rather than retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a contact lens and its performance criteria are based on objective physical, chemical, and biological compatibility measurements, not on expert interpretations of medical images or conditions. The "ground truth" is established by adherence to recognized international standards (e.g., ISO, ANSI) and regulatory guidelines.
4. Adjudication method for the test set:
Not applicable. The tests performed are objective, quantitative measurements (e.g., cytotoxicity, oxygen permeability, refractive index) rather than human-interpreted assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a contact lens, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As noted above, this is a physical medical device, not a software algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests was established by objective standards and regulatory guidelines. This includes:
- International Standards: ISO 10993-5 (In-Vitro Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Acute Ocular Irritation), and ANSI Z80.20 (Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties).
- Regulatory Compliance: Adherence to GLP (Good Laboratory Practice) regulations and 21 CFR 73.3121 for color additives.
- Predicate Device Comparison: The physicochemical and mechanical properties were also compared for "consistent material properties" with the primary predicate device (ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses, K182247).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As this device does not use machine learning, no training set or its associated ground truth was established.
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(132 days)
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.
The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.
- . Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
- Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.
The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Zenostar MT ●
- Cement: EMBRACE Wetbond Resin Cement (K071278) ●
- Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
- Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
- . Abutment design software: 3Shape Abutment Designer™ Software (K151455)
- Milling machine: Wieland-Zenotec Select & Zenotec CAM .
The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.
This document describes Implant Direct Sybron Manufacturing, LLC's Legacy™ SMARTBase Abutments, a dental device intended to provide support for prosthetic restorations in partially edentulous patients. The FDA's 510(k) summary provides information on acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (based on predicate equivalence and established standards) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Fatigue) | Equivalency to the predicate device per ISO 14801:2016 (consistent with FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Abutments). | Results confirmed that the Legacy SMARTBase abutments perform equivalently to the predicate device. (Specific quantitative results, like fatigue limits, are not provided in this summary, but the general statement confirms meeting the equivalency criterion.) |
| Biocompatibility | Meet requirements according to ISO 10993-1 and FDA's corresponding June 2016 guidance for an externally-communicating device with permanent contact (>30 days) with patient bone/tissue/blood. Standards applied include ISO 10993-2, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and ISO 10993-33. | Demonstrated that the devices met biocompatibility requirements for its intended use. (Specific test results like cytotoxicity, irritation, or sensitization indices are not provided, but the statement indicates successful completion according to the standards.) |
| Cleaning and Steam Sterilization Validation | Attainment of a sterility assurance level (SAL) of 10^-6 using the same steam sterilization processes as the predicate device, according to ISO 14947 and ISO 17665-1. | Demonstrated attainment of a sterility assurance level of 10^-6 using the same steam sterilization processes as the predicate device. (Confirms the validated sterilization process achieves the required SAL.) |
| Software Validation (associated CAD/CAM system) | Ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specifications. | Ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specification. (States successful validation, relying on previous validation for the predicate device as the same software and milling unit are used.) |
| Intended Use / Indications for Use | Consistent with, or narrowing of, the predicate device's intended use and indications, without raising different questions of safety or effectiveness. | The Legacy SMARTBase Abutments have the same intended use and similar indications for use as the predicate. Differences either narrow its use or clarify appropriate conditions of use. The target population/conditions are fully encompassed by the predicate. Inclusion of lab scanners is an editorial change. Compatibility with the Legacy implant line (vs. InterActive for predicate) was previously cleared in a reference device. This indicates the device meets the functional equivalence criterion for its intended use. |
| Technological Characteristics | Similar technological elements to the predicate device, including two-piece abutments (titanium base, zirconia top), use in conventional/digital workflows, and similar fundamental design (size, diameter, post height). The main difference (abutment-implant interface) must be addressed by performance data. | Both the subject and predicate devices are two-piece abutments (titanium base, zirconia top), used in conventional and digital workflows with similar auxiliary devices, and feature the same fundamental design. Performance data (fatigue testing) specifically addressed the abutment-implant interface difference by showing equivalency to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (mechanical fatigue, biocompatibility, sterilization validation). However, it mentions that dynamic fatigue testing was performed on "worst-case device configurations" per ISO 14801:2016.
- Test Set Sample Size: Not explicitly stated for each test, but "worst-case device configurations" were used for fatigue testing.
- Data Provenance: The studies are non-clinical (laboratory testing) performed internally by the manufacturer or by third-party labs following international standards (ISO) and FDA guidance. The country of origin of the data is not specified beyond being part of the manufacturer's submission to the FDA. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies are non-clinical, laboratory-based tests for physical, chemical, and biological properties of the device. There is no human "test set" requiring expert ground truth establishment in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is geared towards AI/software performance. While software validation was performed for the associated CAD/CAM software, it is not an "algorithm only" performance study in the typical sense of AI diagnostics. The software (3Shape Abutment Designer Software) is a design tool for the abutment, not a standalone diagnostic or predictive algorithm. Its validation "ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments." This implies a validation of its function within the design workflow, rather than a standalone performance metric for a decision-making algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Mechanical Strength (Fatigue): Ground truth is established by the specified loads and cycles in ISO 14801:2016 and the equivalency standard to the predicate device. The "ground truth" is a pass/fail against these engineering standards.
- Biocompatibility: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards.
- Sterilization Validation: Ground truth is established by achieving a verified sterility assurance level of 10^-6 according to ISO 14947 and ISO 17665-1.
- Software Validation: Ground truth is established by the software's ability to "successfully create abutments employing 3Shape software within established design limitations and specification." This refers to functional correctness and adherence to design parameters.
8. The Sample Size for the Training Set
This document does not describe the development or training of an AI algorithm in the traditional sense, so there is no training set sample size mentioned. The CAD/CAM software mentioned (3Shape Abutment Designer Software) is an off-the-shelf product with an existing design library, not something that appears to have been "trained" by this manufacturer on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set for an AI algorithm described for the device itself, this question is not applicable. The software validation relies on the established functional specifications and design limitations of the 3Shape software and Implant Direct's abutment design library.
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(74 days)
The Venus Legacy BX Device is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV
The Venus Legacy BX device is a non-invasive, non-ablative medical aesthetic device. It is designed to deliver RF (Radio Frequency, 1MHz) energy and PMF (Pulsed Magnetic Field, 15Hz) energy to the skin. RF energy heats the tissue to trigger cellular changes for the intended use. The RF treatment is supplemented with an adjunct magnetic energy for the reduction of the downtime healing process.
The device consists of an RF Power Module, a Pulsed Magnetic Field (PMF) module, two hand piece applicators, and a console with control electronics and an LCD touch screen.
The document provided is a 510(k) premarket notification for the Venus Legacy BX Device, which seeks to demonstrate substantial equivalence to a previously cleared predicate device. It is not a study that proves a device meets specific acceptance criteria through clinical performance data. Therefore, many of the requested details about acceptance criteria derived from clinical studies, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of submission.
The document primarily focuses on demonstrating that the new device has "substantially equivalent" technological characteristics and performance to its predicate.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on non-clinical testing and comparison to a predicate, formal "acceptance criteria" for clinical performance are not explicitly stated or demonstrated with clinical data. Instead, the "acceptance criteria" are implied as matching the specifications and performance of the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance (Venus Legacy BX) |
|---|---|
| Functional Equivalence to Predicate Device: | |
| RF Output Parameters match Predicate Venus Freeze (MP)2 | Bench test demonstrated same RF output specifications as predicate. |
| PMF Output Parameters match Predicate Venus Freeze (MP)2 | Bench test demonstrated same PMF output specifications as predicate. |
| Temperature Stability match Predicate Venus Freeze (MP)2 | Bench test demonstrated same temperature stability profile as predicate. |
| Safety (Electrical, Mechanical) and EMC | Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Similar safety features and compliance to predicate. |
| Biocompatibility of Patient Contact Materials | Complies with ISO10993 Standard; similar materials to predicate. |
| Device Specifications Match Predicate Capabilities: | |
| Maximal RF Output Power (150W) | Matches specification. |
| RF Output Frequency (1MHz) | Matches specification. |
| Magnetic Frequency (Pulse, 15Hz) | Matches specification. |
| Maximal Magnetic Field (15 Gauss) | Matches specification. |
| Inner Design and Components | Similar to the predicate device (console with power supply, RF generator, controller, display panel, and handpiece applicators). |
| Methods and Parameters of Treatment (energy levels, treatment area, duration) | Similar to the respective methods and parameters in the predicate device. |
| Software Validation | Software validation testing (provided in Section 12, though Section 12 is not included in the provided text). |
| Intended Use/Indications for Use | Non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV (for females), which is substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical test set data is provided or referenced in the document for the Venus Legacy BX device. The evaluation was based on non-clinical bench testing comparing the device to its predicate.
- Data Provenance: Not applicable. The "data" presented comes from internal bench testing (RF output, PMF output, temperature stability, safety standards compliance) of the Venus Legacy BX device, compared against the specifications of the predicate device (Venus Freeze (MP)2).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set requiring expert-established ground truth. The comparison was to the technical specifications and proven performance of a predicate device.
4. Adjudication method for the test set
- Not applicable. No clinical test set was conducted that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an aesthetic medical device (RF and PMF energy delivery), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical parameters and energy delivery capabilities.
7. The type of ground truth used
- For the "performance" verification: The "ground truth" was effectively the established technical specifications, safety standards compliance, and proven performance of the predicate device (Venus Freeze (MP)2), which the Venus Legacy BX device aimed to match or demonstrate equivalence to through bench testing.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of the Study (as described in the document):
The "study" conducted for the Venus Legacy BX Device was a non-clinical bench test to demonstrate substantial equivalence to the predicate Venus Freeze (MP)2 device (K111670).
- Objective: To show that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device, despite minor design modifications (outer design only).
- Methodology:
- Bench testing was performed on the Venus Legacy BX device to measure its RF output parameters, PMF output parameters, and temperature stability.
- These measurements were then compared to the reported (or known) RF output measurements, PMF output parameters, and temperature stability of the predicate Venus Freeze (MP)2 device.
- Compliance with voluntary recognized safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) was also assessed.
- Biocompatibility of patient contact materials was confirmed against ISO10993.
- Software validation testing was mentioned as being performed but results not detailed in the provided text.
- Findings: The bench tests demonstrated that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device. The inner design and components, safety features, compliance with safety standards, and intended use/indications for use were found to be similar or substantially equivalent to the predicate.
- Conclusion: Based on the performance testing comparing the Venus Legacy BX device to the predicate device, it was concluded that the Venus Legacy BX device is substantially equivalent for the stated intended use. This means the device met the "acceptance criteria" of being functionally and safely equivalent to the established predicate.
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(196 days)
The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated: Prescription Use, Part 21 CFR 801 Subpart D
Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and
The provided document describes the Legacy Medical Blood Pressure Cuff, which is intended for use with non-invasive blood pressure measuring devices. The document highlights the regulatory submission (510(k) summary) and the performance testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008) for manual, electronic, or automated sphygmomanometers | Tested according to the standard. Non-clinical tests showed substantial equivalence in functional and operational performance characteristics including compression, pressure control, and leakage when connected to inflation and measurement equipment. |
| ISO 10993-5 (1999) Biological evaluation of medical devices, Part 5: Tests for In Vitro cytotoxicity | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
| ISO 10993-12 (Date not specified) Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "comparative bench testing" as the method used to assess and prove similarity of function between the Legacy Medical Blood Pressure Cuff and predicate devices.
- Sample Size: The document does not specify the sample size used for the test set. It only mentions "non-clinical tests."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "bench testing," it's likely conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document describes "non-clinical tests" and "comparative bench testing" for functional and operational performance. This type of testing typically relies on standardized measurement equipment and protocols rather than human expert opinion to establish ground truth for performance parameters like compression, pressure control, and leakage.
Therefore, this section is not applicable as expert consensus is not the method for establishing ground truth for these types of mechanical and functional performance tests.
4. Adjudication Method for the Test Set:
As mentioned above, the testing involved "comparative bench testing" against predicate devices using objective measurements. This typically does not involve an adjudication method in the context of human interpretation or review. Therefore, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Non-clinical tests - comparative bench testing was utilized to assess and prove similarity of function." This type of study focuses on mechanical and functional performance, not human reader interpretation of images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical blood pressure cuff, not an algorithm or AI system. The testing described is for the physical and functional aspects of the cuff.
7. The Type of Ground Truth Used:
The ground truth for the "comparative bench testing" appears to be based on objective measurements performed in accordance with established engineering and medical device standards (ANSI/AAMI SP10, ISO 10993). The performance of the Legacy Medical Blood Pressure Cuff was compared against these standards and against the performance of predicate devices.
8. The Sample Size for the Training Set:
This section is not applicable. The device is a physical medical device (blood pressure cuff), not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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(126 days)
Legacy3 6mm Length consists of two-picce implants for one-stage on two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The Legacy3 6mm length implants consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.
The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work.
The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy.
The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.
The provided text describes a 510(k) submission for the "Legacy3 6mm Length Implants." This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. Therefore, the "acceptance criteria" are typically the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" refers to the non-clinical performance testing conducted to support this claim of substantial equivalence.
Here's the information broken down:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate Devices) | Reported Device Performance (Legacy3 6mm Implants) |
|---|---|---|
| Intended Use | Must be the same as or very similar to predicate devices: Use in partially and fully edentulous upper and lower jaws for single or multiple-unit restorations, fixed bridgework, and immediate loading with good primary stability and appropriate occlusal loading. | "Legacy3 6mm Length implants... are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading." This matches the predicate devices' intended use. |
| Material | Must be comparable to predicate devices. (Titanium Alloy (Ti 6AL-4V ELI) or Commercially pure Titanium) | Titanium Alloy (Ti 6AL-4V ELI) - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices). |
| General Design | Threaded, root-form implant design. | Threaded, root-form implant - same as Legacy 8mm, SwissPlant 6mm, and Straumann (Own Predicate/Reference Devices and Predicate Device). |
| Placement Method | Dual or single-stage surgery. | Dual or single-stage surgery - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices). |
| Implant Surface | SBM (Soluble Blasted Media) or other roughened surface. | SBM (Soluble Blasted Media) or SBM with HA-coating. SBM is the same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices). |
| Surface Roughness | SBM = 1.5-2.3μm. | SBM = 1.5-2.3μm - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices). |
| Mechanical Strength | Equivalent mechanical safety (strength) to predicate devices, meeting FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 standards (static compression bending, fatigue, implant driving torque, abutment/screw torque to failure). Able to withstand loads higher than functional masticatory loads. | Laboratory testing was conducted following FDA guidance and ISO 14801 for worst-case devices. Components "have shown to exhibit equivalent mechanical strength as the predicate devices and the implant/abutment combinations were able to withstand loads that were higher than the functional masticatory loads." |
| Surface Area Analysis | Demonstrate substantial equivalence in external osseointegration surface area compared to predicate devices. | "Comparative surface area analysis was performed to demonstrate substantial equivalence by creating 3D models of the implants and obtaining the total external osseointegration surface area using three dimensional CAD measurement function." The text implies this analysis supported substantial equivalence. |
| Pull-out Testing | Demonstrate substantial equivalence in pull-out strength in simulated bone, considering potential bone loss. | "Furthermore, comparative pull-out testing was conducted to demonstrate substantial equivalence by inserting the implants into simulated bone taking into account 3mm of potential bone loss." The text implies this testing supported substantial equivalence. |
| Sterilization | Validation in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation. | "Sterilization Validation was carried out in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation." The method is validated. |
| Device Dimensions | While the length is new (6mm), other dimensions (body diameter, platform diameter) should be comparable to existing product lines or justified as variations. | The device offers six body diameters (3.7, 4.2, 4.7, 5.2, 5.7, and 7.0 mm) and three platform diameters (3.5, 4.5, and 5.7 mm). The 6mm length is specifically cited as a line extension to allow for restoration options where an 8mm implant would not work, and the shorter version required minor changes to the outer body design taper and thread depth to maintain adequate thread engagement and surface area equal to or greater than predicate devices. This demonstrates that variations are justified and performance is maintained. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical performance testing, primarily mechanical and physical characterization, to demonstrate substantial equivalence.
- Sample Size for Test Set: Specific sample sizes for each mechanical test (static compression bending, fatigue, driving torque, screw torque) are not explicitly stated in the provided text. However, the testing was done for "worst-case devices," implying a selection of implants representing the range of sizes or configurations most likely to fail.
- Data Provenance: The data provenance is from laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, which is based in Calabasas Hills, CA, USA. This is an experimental/testing type of data. It is not patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the ground truth was established through non-clinical engineering and laboratory testing in accordance with recognized standards (FDA guidance, ISO 14801, ISO 11137-2, AAMI TIR-33). Ground truth in this context refers to the measured performance against established engineering benchmarks rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there was no human reader interpretation or clinical adjudication involved in the non-clinical performance testing. The "ground truth" was derived from direct physical and chemical measurements against defined engineering specifications and regulatory standards.
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 submission is for a medical device (dental implant), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating substantial equivalence for the Legacy3 6mm Length Implants was based on:
- Engineering Specifications and Standardized Test Results: Compliance with established mechanical and physical performance benchmarks defined by FDA guidance ("Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (ISO 14801 for mechanical testing, ISO 11137-2 and AAMI TIR-33 for sterilization).
- Comparative Analysis: Demonstrating that the new device's performance (e.g., mechanical strength, surface area, pull-out strength) is equivalent to or better than that of already legally marketed predicate devices.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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(507 days)
The intended use is to provide muscle relaxation therapy by delivering a soothing massage.
Legacy-500 Massage Table is an electrically powered, motorized, multifunctional physical therapy table. The intended use is to provide muscle relaxation therapy by delivering a soothing massage. It is designed to travel throughout the back area in a smooth transition but can also stop in one specific area. Pressure of the massage can be adjusted from one (lowest setting) to six (highest setting) and is displayed by six lights. Rollers can massage clockwise or counter-clockwise and the indicator displays the position on the back. The timer allows the table to run from one to thirty minutes shutting power off after treatment time and returning the pressure of the rollers to the lowest setting, at any time during treatment the timer can be manually shut off to stop the table by user or patient. The only patient contacting component is the table top that the patient lays on covered in vinyl upholstery.
This document is a 510(k) summary for a massage table, not a clinical study report for an AI/ML powered medical device. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not applicable.
Here's an attempt to address the questions based on the provided text, noting where the information is absent:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or device performance in the context of an AI/ML algorithm. Instead, it demonstrates "substantial equivalence" to predicate devices, which is the regulatory standard for 510(k) submissions. The "performance" is implied by matching features and intended use with already cleared devices.
| Feature (from Comparison Table) | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Legacy-500) |
|---|---|---|
| Intended use: Designed to release muscle tension and deliver a soothing massage. | Yes | Yes |
| Substantially same size and shape. | Yes | Yes |
| Achieve the same physiological effects. | Yes | Yes |
| Three six-inch diameter massage rollers. | Yes | Yes |
| Clockwise and counter-clockwise roller rotation. | Yes | Yes |
| Adjustable roller pressure (varying degrees of pressure on muscles on back). | Yes | Yes |
| Height of rollers can adjust three inches above baseline table surface. | Yes | Yes |
| 30-minute timer that shuts power off after cycle time and is also used as the safety shut off. | Yes | Yes |
| Have the same type of frame construction. | Yes | Yes |
| Have steel roller carriage. | Yes | Yes |
| Can massage full back or selectable area. | Yes | Yes |
| Have lighted height indicator. | Yes | Yes |
| Have same style electrical components and motors. | Yes | Yes |
| Ten (10) minute recommended treatment time. | Yes | Yes |
| Covered in vinyl upholstery. | Yes | Yes |
| One control / indicator panel at head end of table to prevent patient from kicking controls when getting on. | Variation from predicates accepted | Yes (Difference noted but accepted for SE) |
| Indicator panel at head end and control panel at foot end of table. | Predicates have this | No (Device differs here) |
| Has optional hand-held control and heat option. | One predicate has this | No (Device differs here) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The document describes a physical medical device (massage table), not an AI/ML algorithm tested with a data set. The "test set" in this context would be the physical device itself and its adherence to design specifications compared to predicate devices. There is no mention of data or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or medical records) is not relevant here. The "ground truth" for a massage table's substantial equivalence is its intended use, design features, and safety compared to established predicate devices, as evaluated by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of an adjudication method as would be used for expert review of data in an AI/ML context. The FDA's review process is an assessment against regulatory requirements and comparison to predicates.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. No AI component is described or evaluated in this 510(k) submission. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm or software component described in this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the typical AI/ML sense. The "ground truth" for this medical device submission is effectively the established characteristics, safety, and effectiveness of the legally marketed predicate devices (K010252, K002390, K993461). The manufacturer is demonstrating that their device shares these fundamental characteristics.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set or corresponding ground truth establishment process described.
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(45 days)
The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The Legacy System consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads near the top of each implant, are manufactured using the same medical grade titanium allov material and are coated with the same soluble blast media (SBM) blasted surface treatment or HA plasma sprayed. The HA coated variety of these implants are the subject of this submission
The provided text is a 510(k) summary for a dental implant device (Legacy System Dental Implants With HA Coating). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically seen for AI/ML-driven devices or diagnostics.
Therefore, the requested information elements related to specific acceptance criteria, study design (sample size, data provenance, expert consensus, adjudication, MRMC, standalone performance, training set details), are not available in the provided document.
The document primarily addresses the following for the Legacy System Dental Implants With HA Coating:
- Device Description: Tapered screw-type endosseous implants with specific thread configurations, made of medical grade titanium alloy, with soluble blast media (SBM) blasted surface treatment or HA plasma sprayed.
- Intended Use: Identical to predicate devices, for single-stage or two-stage surgical procedures in the mandible and maxilla, supporting single/multiple-unit fixed restorations and retention of overdentures, including immediate placement and function.
- Device Comparison: Found to be favorably comparable to predicate devices (Zimmer Dental Tapered Screw-Vent Dental Implant System K013277 and Implant Direct's Spectra-System K061319) in terms of function, technological characteristics, intended use, and materials.
- Substantial Equivalence: The FDA determined the device to be substantially equivalent to legally marketed predicate devices. This means it has the same intended use and technological characteristics as the predicate devices, or if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
Without the specific study results, acceptance criteria, and performance metrics, it is impossible to complete the table or answer most of your detailed questions.
However, I can provide a general interpretation based on the document's content:
Implied Acceptance Criteria (based on 510(k) process):
For a traditional 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as the predicate. This is typically achieved by comparing:
- Intended Use: Must be the same as the predicate.
- Technological Characteristics: Must be the same, or if different, must not raise new questions of safety and effectiveness.
- Performance: While not explicitly detailed with specific metrics in this summary, the safety and effectiveness of the traditional dental implant are implied to be "acceptable" if they are equivalent to the predicate. This would typically involve biocompatibility testing, mechanical testing (fatigue strength, torque, etc.), and potentially animal or clinical studies if new questions of safety or effectiveness arise.
Since this is a traditional 510(k) for a physical medical device (dental implant) and not an AI/ML diagnostic tool, many of your questions regarding AI-specific criteria (MRMC, standalone performance, training sets, expert adjudication methods) are not applicable to the information provided.
Summary of what can be gleaned (or inferred) from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device: | Achieved: FDA determined substantial equivalence (DEC 10, 2007). |
| Same Intended Use | "identical to the intended use of the predicate abutments" |
| Similar Technological Characteristics | "nearly identical technological characteristics" |
| Similar Materials | "same medical grade titanium alloy material" |
| Similar Principle of Operation | "used in an identical function as the cited predicates" |
| As Safe and Effective as Predicate | Implied by substantial equivalence finding. |
2. Sample size used for the test set and the data provenance: Not applicable/Provided. This document does not detail a clinical study with a "test set" in the context of diagnostic performance. Any testing (e.g., mechanical, biocompatibility) would have been internal and compared to standards or predicate device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring ground truth from experts in a test set.
4. Adjudication method 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 medical device, not an AI-assisted diagnostic.
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: Not applicable in the context of AI/ML or diagnostic performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by engineering tests and clinical outcomes, compared to established standards and predicate devices.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model for which a training set is relevant.
9. How the ground truth for the training set was established: Not applicable.
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