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Geistlich Bio-Gide® is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth; and
• guided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

• augmentation or reconstructive treatment of the alveolar ridge;
• filling of periodontal defects;
• filling of defects after root resection, apicoectomy, and cystectomy;
• filling of extraction sockets to enhance preservation of the alveolar ridge;
• elevation of the maxillary sinus floor;
• filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
• filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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. This is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical 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. This is not an AI-assisted device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

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The contact forte Alpha is a Processor and is intended for use with the Sophono Headband or Softband (no age limitations), or with the Sophono Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1.2, and 3 kHz).

• Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies.

• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an Air Conduction Contralateral Routing of Signal (AC CROS). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The contact forte Alpha Processor is a sound processor that converts sound into mechanical vibrations. The sound processor is magnetically connected to a Sophono Headband, Sophono Softband or Sophono Attract Magnetic Spacer by the integrated metal disk. Sound enters the audio processor through the microphones, which then goes through a DSP chip for signal processing. The output of the DSP chip drives an electromechanical transducer, which converts the signal into mechanical vibrations. These vibrations are transferred to the patient's skin through the Sophono Headband, Sophono Softband or the Sophono Attract magnetic spacer. The vibrations are carried through the patient's skin and skull to the cochlea where they are perceived as sound. The device is designed for use on either the right or left side application. The device has a "oval" housing with a symmetrical design ( for right or left side application). The material used: Plastic contact with intact skin;

The FDA 510(k) Clearance Letter for the "contact forte Alpha" bone-conduction hearing aid (K243041) outlines performance data demonstrating the device's substantial equivalence to its predicate, the Sophono Alpha 2.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of quantitative acceptance criteria with corresponding performance numbers for the contact forte Alpha versus the Sophono Alpha 2. Instead, it relies on qualitative statements of equivalence and "good concordance" for certain measurements. The core acceptance criterion seems to be demonstrating comparable performance and no significant difference in key audiometric and output parameters compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Field Tests: 5 patients.
• Data Provenance: The document states "Field testing was conducted with five patients". Given the applicant, BHM-Tech Produktionsgesellschaft mbH, is located in Austria, and the device is manufactured there, it is highly probable the field tests were conducted in Austria or a similar European setting. The trials are implicitly prospective in nature, as they involve testing the contact forte Alpha in real-world conditions on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the field test data beyond the general statement that "audiometric thresholds and speech perception thresholds" were assessed. For a hearing device, establishing ground truth would typically involve audiologists performing standardized audiological assessments. The document implies a direct comparison of the subject device and predicate on the same individuals, where the individuals' own established hearing thresholds serve as a baseline, and the objective measurements (audiometric thresholds, speech perception thresholds) and subjective reports are the core data points.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method beyond comparing the subject and predicate devices on the same patients and collecting objective measurements and subjective feedback. There is no mention of "2+1" or "3+1" methods typically used for image-based diagnostics. The comparison is direct and within-subject for the field test.

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 is not applicable to this device. The contact forte Alpha is a bone-conduction hearing aid, not an AI-assisted diagnostic tool where human readers/interpreters would "improve" with AI assistance. The performance evaluation focuses on the device's ability to amplify and transmit sound comparably to a predicate device, as perceived by patients and measured by audiometric tests.

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

This is not applicable in the traditional sense for this device. The "performance" of a hearing aid is inherently human-in-the-loop, as its function is to assist human hearing. However, the document does describe non-clinical tests such as "Magnetic Retention forces" and "Output Level Measurements" which are standalone assessments of the device's physical and acoustic properties without a human user. These non-clinical tests were performed independently of human perception.

7. The type of ground truth used:

The ground truth for the performance evaluation in the clinical field tests consisted of:

• Objective Audiometric Measurements: "Audiometric thresholds and speech perception thresholds" measured with both the predicate and subject devices. This is a form of objective functional assessment.
• Subjective User Reports: "The patients reported that they did not notice any subjective difference in hearing between the two devices." This is outcomes data based on patient perception.
• Technical Specifications/Measurements: For non-clinical tests, the "ground truth" is adherence to predefined engineering specifications and comparison against the predicate's known performance for parameters like "Magnetic Retention forces" and "Output Level Measurements."

8. The sample size for the training set:

The document does not specify a training set size. This device is a hearing aid, not an AI/machine learning model that typically requires a large training dataset for model development. The development and validation likely followed traditional engineering design and testing principles, not machine learning paradigms involving distinct training and test sets in the AI context.

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

As there's no mention of a training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and development would stem from established audiology principles, acoustic engineering standards, and the performance characteristics of the predicate device.

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The FORTEZZA Spinal Stabilization System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the FORTEZZA Spinal Stabilization System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the FORTEZZA Spinal Stabilization System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The FORTEZZA Spinal Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The FORTEZZA Spine Stabilization System consists of a variety of shapes and sizes of screws and 5.5 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy. Components of the system include straight and pre-bent rods, multi-axial screw.

This document is a 510(k) summary for the FORTEZZA Spinal Stabilization System, a medical device. It does not describe any clinical studies involving humans or AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical, bench testing.

Therefore, the requested information elements related to clinical studies, AI performance, ground truth, experts, and sample sizes for training/test sets are not applicable to this document.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a number of devices/tests, but implicitly refers to the number of samples required by ASTM F1717-14 for mechanical testing.
• Data Provenance: Not applicable for mechanical bench testing. The data is generated in a laboratory setting through controlled experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No human experts were involved in establishing "ground truth" for these mechanical performance tests. The ground truth is determined by the physical properties and mechanical behavior of the device components under standardized test conditions specified by ASTM F1717-14.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of mechanical bench testing. Performance is measured against pre-defined engineering and material 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

• Not Applicable. This document describes a medical device for spinal stabilization, not an AI-powered diagnostic or interpretive tool. No MRMC studies were conducted.

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

• Not Applicable. This document describes a physical medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance testing is based on engineering and material science standards and measurements. Specifically, the device's mechanical properties (static compression bending, static torsion, fatigue compression bending) are measured and compared against the properties of a predicate device, as required by ASTM F1717-14 and FDA guidance.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of this type of medical device submission (mechanical testing for substantial equivalence).

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

• Not Applicable. As there is no training set, there is no ground truth for a training set.

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Quanta Forte and its Hand Pieces are intended for use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.

Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

Quanta Forte with 415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.

Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (1-VI) to the Fitzpatrick Scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (1-VI) to the Fitzpatrick scale.

Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

Quanta Forte with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:

· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

· Removal or lightening of unwanted hair (with and without adjuvant preparation)

· Treatment of pseudofolliculitis barbae (PEB)

• Permanent hair reduction is 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.

Quanta Forte system is an Intense Pulsed Light (IPL) and laser emitting device that is operated with a handpiece in contact with the skin.

Quanta Forte comprises a main console unit and several handpieces that are triggered by means of a footswitch or a finger switch.

A microprocessor based system controller is used to monitor and direct all the system functions and the graphic user interface.

The main console can be connected to the following handpieces:

• -415-950 nm Intense Pulsed Light
• 535-950 nm Intense Pulsed Light .
• -580-950 nm Intense Pulsed Light
• -635-950 nm Intense Pulsed Light
• -808 nm laser diode
• -1064 nm ND:YAG laser
• -2940 nm Erbium:YAG laser

The provided text does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the performance metrics, sample sizes, ground truth establishment, or expert involvement in such studies.

This document is a 510(k) summary for the Quanta Forte device, which focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with safety, EMC, and software verification standards. It does not present a de novo clinical study with performance metrics against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document only mentions:

• Safety and electromagnetic compatibility (EMC) testing: The system complies with IEC 60601-2-22, IEC 60601-2-22, IEC 60601-2-57 for safety and IEC 60601-1-2 for EMC. (These are compliance standards, not performance metrics and acceptance criteria in the context of diagnostic or interpretive AI).
• Software Verification and Validation Testing: Conducted as recommended by FDA guidance. (Again, this is a process, not a performance study).

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ZPS One-Third Tubular Plates, T-Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• · supracondvlar fractures
• extra-articular fractures
• · fractures in osteopenic bone
• nonunions
• · malunions

Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.

ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process

The ZPS System is a non-locking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The Forte Cancellous Screws are used with the ZPS Plates to form a fixation construct.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Zimmer Plates and Screws System (ZPS):

Device Name: Non-sterile Zimmer® Plates and Screws System (ZPS) Compression/Reconstruction/Symphyseal Plates and Forte Cancellous Screws

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a number of devices. Descriptions relate to the types of ZPS plates and Forte screws and their corresponding predicate devices that underwent testing.
• Data Provenance: Non-clinical (laboratory testing). No information on country of origin, but it's implied to be internal testing by Zimmer, Inc. The testing was retrospective as it was conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The "ground truth" for the non-clinical performance evaluation was established through standardized testing methodologies (e.g., ISO 10993-1, mechanical testing protocols). No human experts were involved in establishing "ground truth" for these performance metrics.

4. Adjudication Method for the Test Set:

• Not applicable. The performance data is objective and derived from physical testing, not subjective human assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for these devices."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Not applicable. This is a medical device (plates and screws), not an algorithm or AI system. Its performance is assessed physically, not through computational means.

7. Type of Ground Truth Used:

• The ground truth for the non-clinical performance data was based on:
  • Standardized testing protocols: For biocompatibility (ISO 10993-1) and mechanical properties (static, fatigue, beam bending).
  • Predicate device performance: The "ground truth" for comparative effectiveness was the established performance of the legally marketed predicate devices. The new device was deemed acceptable if its performance was "similar" to these predicates.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set.

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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Fortex Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The purpose of this 510(k) submission is to add rods made of a different material to the Fortex Pedicle Screw System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared Fortex Pedicle Screw System.

Both the modified and predicate Fortex Pedicle Screw System consist of various screws, rods, and cross bar connectors that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion.

The components of the predicate Fortex.Pedicle Screw System are fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537, in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy rods does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text describes a 510(k) submission for the Fortex Pedicle Screw System, specifically focusing on the addition of rods made from a different material (cobalt chrome alloy). The submission aims to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria for a device performance study in the way you've outlined, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the performance data presented is for non-clinical mechanical testing to demonstrate the structural integrity and comparability of the modified device components.

Here's a breakdown based on the information available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This table reflects mechanical performance, not clinical or diagnostic performance criteria as typically found in studies for AI/diagnostic devices.

Information Not Found in the Provided Text:

The following points are pertinent to studies of diagnostic or AI-driven medical devices, but are not applicable to this 510(k) submission, which focuses on a change in material for a spinal implant system. Therefore, the requested information for these points is not available in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components for mechanical testing, not patient 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. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to mechanical testing.
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 spinal implant, not an AI or diagnostic device designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance metrics defined by ASTM F1717 standards.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Mechanical Testing):

The study involved non-clinical performance testing of the Fortex Pedicle Screw System. This included static and dynamic axial compression bending and static torsion tests. The tests were conducted according to ASTM F1717 standards. The performance of the modified system (with cobalt chrome alloy rods) was compared to the predicate system. The results demonstrated that the modified device functioned as intended and showed substantial equivalence in mechanical properties to the predicate devices. The purpose was to demonstrate that adding a new material (cobalt chrome alloy) for the rods does not introduce new safety or effectiveness concerns, and that its mechanical performance is comparable to an already cleared device.

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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Fortex Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Fortex rods are 5.5 mm diameter solid cylinders with spherically rounded ends, provided in 40 mm, 60 mm, 70 mm, 80 mm, 120 mm, 120 mm, 160 mm, 180 mm, 200 mm, and 300 mm lengths.

Each Fortex pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Selftapping pedicle screw assemblies are provided in diameters of 4.75mm, 5.5 mm, 6.5 mm, 7.5 mm and 8.25mm. All screw assemblies are provided in lengths of 30 mm, 35 mm, 45 mm, 50 mm, and 55 mm. Screws are provided in canulated and non-canulated configurations.

The Fortex cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.

The rods, pedicle screws and cross bars of the Fortex Pedicle Screw System are made of titanium alloy conforming to ASTM F136.

The provided text is a 510(k) summary for a medical device (Fortex Pedicle Screw System) which is a premarket notification to the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing indications for use and technological characteristics, and typically relies on non-clinical (e.g., mechanical) testing rather than clinical studies with human subjects.

Therefore, I cannot fulfill your request for information about acceptance criteria and associated study details based on the provided text. The document does not contain this kind of data.

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GRADIA FORTE is intended to be used for the indirect restoration of crown & bridge, inlays, veneers and implant superstructures.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment for the GRADIA FORTE device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a legally marketed predicate device for its indicated uses. It does not contain the kind of detailed study breakdown you've requested.

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The MectaCer BIOLOX® forte Femoral Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of the following:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-. traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis.
• Congenital hip dysplasia .
• . Ankylosing spondylitis
• Avascular necrosis of the femoral head .
• Acute traumatic fracture of the femoral head or neck .
• Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

The MectaCer BIOLOX® forte Femoral Heads are ceramic ball heads intended for mechanical fixation to a mating hip stem and indicated for the treatment of patients who are candidates for total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery.

The MectaCer BIOLOX® forte Femoral Heads consist of High Purity Aluminium Oxyde Ceramic, Al2 O3 per standard ISO 6474:1994, Implants for surgery --Ceramics materials based on high purity alumina, Type A. The MectaCer BIOLOX® forte Femoral Heads are available in various sizes from 28, 32 and up to 36 mm diameters.

Here's an analysis of the provided text regarding the MectaCer BIOLOX® forte Femoral Heads, focusing on acceptance criteria and supporting studies:

This submission (K073337) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than a clinical trial proving device efficacy against specific acceptance criteria for performance. Therefore, the information provided primarily refers to bench testing and adherence to international standards for the device's material and mechanical properties, not a study evaluating clinical performance (e.g., patient outcomes, diagnostic accuracy).

The document does not describe a study in the traditional sense of evaluating an algorithm or AI's performance against specific clinical acceptance criteria for diagnosis or treatment. Instead, it details the engineering and material performance of a hip implant component.

Here's a breakdown of the requested information based on the provided text, with notes where information is not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are standards for the material and mechanical performance of the femoral head, not diagnostic or clinical accuracy. The "reported device performance" is that the device conforms to these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in the context of clinical data or patient cases. The testing described is bench testing of the physical device. Therefore, the "sample size" would refer to the number of femoral head units subjected to mechanical and material tests. This number is not provided in the summary.
• Data Provenance: The data provenance is from laboratory testing/bench testing conducted by the manufacturer, MEDACTA International SA, located in Switzerland. It is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable. This is a physical device (hip implant component) and the "ground truth" is established by adherence to engineering and material standards, not by expert consensus on clinical findings or images. The "ground truth" for the material composition and mechanical properties is based on the specifications within the cited ISO and ASTM standards.

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is for physical properties against defined standards, there is no need for expert adjudication in the same way as with diagnostic image interpretation. The "adjudication" is met by demonstrating conformity to the specified technical parameters of the 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

• Not Applicable. This device is a passive hip implant component, not an AI or diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

• Not Applicable. This device is a passive hip implant component, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" is based on established international standards for ceramic materials (ISO 6474), mechanical testing of hip prostheses (ISO 7206-10), and taper connections (ASTM F-2009-00), as well as sterilization (AAMI/ANSI/ISO 11137). These standards define the expected physical and material properties that the device must meet.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI or machine learning device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set, this question is not relevant.

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The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:

• The patient should be skeletally mature.

· The patient's condition should be due to one or more of the following:

1. Osteoarthritis.

2. Rheumatoid arthritis.

3. Tumor conditions involving the upper third of the femur or of the Acetabular.

4. Ankylosing spondylitis.

5. Psoriatic arthritis.

6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.

7. Non union of femoral neck fracture or avascular necrosis of the femoral head.

8. Post-traumatic fracture/dislocation of the hip.

9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.

10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.

11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.

The provided document pertains to a 510(k) premarket notification for the Portland Ceramic (Biolox-Forte) Femoral Head, a ceramic femoral head prosthesis. It describes the device, its indications for use, and a summary of testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain information typically associated with acceptance criteria and studies for AI/ML-driven medical devices.
Instead, it details the regulatory submission for a physical medical implant. Therefore, the questions about AI/ML device performance, ground truth, expert adjudication, and training/test set sizes are not applicable to this document.

The "SUMMARY of TESTING" section states that "Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head." This suggests that the acceptance criteria for this medical device relate to its material properties, mechanical performance, and compliance with established standards for ceramic femoral heads, rather than diagnostic accuracy or algorithmic performance.

Without further information on the specific analytical and mechanical testing conducted, it is not possible to provide a table of acceptance criteria and reported device performance in the format requested for AI/ML devices.

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