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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Regarding the other points of the prompt, as applied to this document:

2. Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.

The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation.

MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex.

The MIS M4 Implants are available in the following diameters, platforms and lengths:

• Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
• Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm
• . Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
• Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm
• . Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm

MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths:

• Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
• Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
• Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm
• Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
• . Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm
• The implants are designed for both two-stage procedures, with one internal thread for screwed abutment.

The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.

Components:
The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments.

Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of TI 6AL 4V ELI, and supplied sterile to the user, for single use.

Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.

CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. They are supplied non sterilized by the user according to the labeling, and intended for single use.

Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is burned out for casting with precious metals.. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non sterilized by the user according to the labeling, and intended for single use.

Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of TI 6AL 4V ELI. The overdenture is connected to the multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use.

OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.

Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation. They are straight abutments. They are available in TI 6AL 4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from TI 6AL 4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration, as directed in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.

There are two types of emergence profiles among the abutments, concave or straight emergence profile.

This document is a 510(k) Summary for the MIS Internal Hex Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to legally marketed predicate devices through non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

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

The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific acceptance criteria with quantifiable metrics for each device performance aspect. Instead, it states that the device's performance is "at least equivalent" to the predicates. The primary performance metric mentioned is fatigue testing.

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 does not explicitly state the sample sizes used for the non-clinical tests (e.g., number of implants/abutments tested for fatigue). It mentions "worst case implants and abutments chosen for the tests" but no specific numbers.

• Sample Size: Not specified (implied to be sufficient for engineering testing validation).
• Data Provenance: The tests were conducted by MIS Implants Technologies Ltd. (Israel) or an "independent testing laboratory" for shelf life. No country of origin is explicitly stated for each test, but the submitter is based in Israel and the US Agent in the USA.

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. The study involves non-clinical engineering and laboratory testing (mechanical, sterilization, biocompatibility, shelf-life, risk analysis) of a dental implant system, not a diagnostic or AI-driven device requiring expert-established ground truth.

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

This section is not applicable for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or human-in-the-loop study was conducted. This device is a dental implant system, not an AI or diagnostic tool.

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

This section is not applicable. This device is a physical dental implant system, not a standalone algorithm.

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

For the non-clinical tests conducted, the "ground truth" refers to established engineering and regulatory standards:

• Fatigue: ISO 14801:2016 standard.
• Sterilization: ANSI/AAMI/ISO 11137-1, -2; ANSI/AAMI/ISO 17665-1, -2.
• Endotoxin: USP 85, USP 161, ANSI/AAMI/ ST72.
• Disinfection: ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.
• Shelf Life: ISO 11607-1.
• Risk Analysis: ISO 14971.

8. The sample size for the training set

This section is not applicable. There is no training set as no AI/machine learning component is involved.

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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MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS CONNECT Conical Connection abutment is an endosseous dental implant abutment device which is intended for use by a dental clinician with a root-form endosseous dental implant to aid in prosthetic rehabilitation, by incorporation in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT Conical Connection abutment is intended to be used with MIS Conical Connection Implants, such as MIS V3 Conical Connection Dental Implant System and Connection Implants cleared under K112162 and K163349, respectively, and is intended to be placed above the bone level and within the gingival tissue. The MIS CONNECT Conical Connection abutment can be fitted with a variety of complementary accessories, including Healing caps, Cementing caps and Temporary abutments (which are proposed for clearance in the present submission), and also including Prosthetic screws, Impression copings, Analogs, and Scan posts (which are class I products and are therefore exempt from clearance requirements). The MIS CONNECT Conical Connection abutment is not intended to be removed.

The provided text describes the 510(k) summary for the MIS CONNECT Conical Connection Abutment. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) is generally not present in such a document.

However, based on the provided text, I can extract and infer some information regarding acceptance criteria and performance studies, specifically non-clinical ones.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify the exact number of units used for each non-clinical test (e.g., how many abutments were subjected to fatigue testing). It refers to "test articles."
• Data Provenance: The studies are non-clinical, laboratory-based mechanical and sterilization tests, performed by MIS Implants Technologies Ltd. (Israel) and an "independent testing laboratory" for shelf life. No geographical or temporal patient data (retrospective/prospective) is involved, as these are not clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable. The studies described are non-clinical (mechanical, sterilization, biocompatibility rationale), not requiring expert consensus on clinical findings or "ground truth" as might be established for diagnostic AI.

4. Adjudication Method for the Test Set

• This information is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for radiology or pathology assessments, to establish a definitive diagnosis based on multiple reader opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. The submission describes non-clinical testing for a dental implant abutment and its superstructures.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone study was not done. This concept applies to AI/software as a medical device (SaMD). The device in question is a physical dental implant component, not an algorithm.

7. The Type of Ground Truth Used

• This information is not applicable in the context of this 510(k) submission for a physical medical device. "Ground truth" (e.g., pathology, outcomes data) is typically established in clinical studies or for diagnostic devices. For this device, "ground truth" in the context of the studies means adherence to established engineering standards (e.g., ISO 14801:2007 for fatigue, specific ISO and AAMI standards for sterilization).

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The device is a manufactured medical component.

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

• This information is not applicable as there is no training set or AI component.

Ask a specific question about this device

MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile.

This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants.

Components:
The MIS C1 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP implants.

The acceptance criteria described in this document are for the MIS C1 Narrow Platform Conical Connection Implant System and MIS C1 Wide Platform Conical Connection Abutments.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical performance tests conducted to demonstrate substantial equivalence. The "acceptance criteria" are implied by successful completion of these tests in accordance with relevant ISO standards.

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

• Sample Size: The document does not specify the exact numerical sample size for the fatigue testing or sterilization validation. It refers to "the worst case narrow platform implant and abutment" for fatigue testing. For sterilization, it mentions "each group of products" and "abutments supplied non-sterile".
• Data Provenance: The studies are non-clinical (laboratory testing). The document heavily references ISO and AAMI standards. The manufacturer is "MIS Implants Technologies Ltd." based in "Bar Lev Industrial Park, ISRAEL". This suggests the testing was likely conducted in Israel or by contract labs following international standards. The document does not mention retrospective or prospective data as it pertains to clinical studies, which were not performed.

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

This section is not applicable as the ground truth for these tests is established by physical measurements and compliance with engineering and sterilization standards, not expert clinical consensus.

4. Adjudication Method

This section is not applicable as the "ground truth" (i.e., test results meeting predefined acceptance criteria) is determined by objective physical and biological testing, not by expert adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

No, a standalone "algorithm only" study was not done. This device is a physical medical implant, not an AI or software-as-a-medical-device (SaMD) product. Performance is determined by non-clinical engineering and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on:

• Engineering Standards: For mechanical fatigue, compliance with ISO 14801:2007.
• Sterilization and Biocompatibility Standards: For sterilization (ANSI/AAMI/ISO 11137-1, 11137-2, 17665-1, 17665-2), endotoxin testing (USP 85, USP 161, ANSI/AAMI/ ST72), disinfection (ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011, AAMI TIR 12:2010), and biocompatibility (implied equivalence to previously cleared predicate).
• Shelf Life Standards: For package integrity, compliance with ISO 11607-1.

These are objective, measurable criteria established by recognized national and international standards.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental implant system and does not involve machine learning or AI, thus there is no "training set."

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

This section is not applicable for the same reasons as above.

Ask a specific question about this device

MIS V3 Conical Connection Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants. The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone. The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm; 3. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants surface is sand blasted and acid etched. The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows: "Narrow Platform" (NP) – 3.3mm diameter: blue; "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple. The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch). Components: The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

The provided text describes a 510(k) premarket notification for a dental implant system (MIS V3 Conical Connection Dental Implant System) and focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria based on a clinical study of its performance. The document primarily details mechanical and material equivalency, as well as biocompatibility and sterilization, as opposed to performance metrics that would typically arise from an AI/ML-based medical device.

Therefore, many of the requested items (acceptance criteria table, sample size for test set, expert involvement, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it pertains to a physical dental implant, not an AI/ML device requiring such performance studies.

However, I can extract and present the acceptance criteria for mechanical performance and the study that proves the device meets those from the document, as it is a physical device and not an AI/ML algorithm.

Here's the information that can be extracted relevant to the device's mechanical and material acceptance:

Acceptance Criteria and Device Performance for MIS V3 Conical Connection Dental Implant System

The "acceptance criteria" for this dental implant system are implicitly defined by proving its substantial equivalence to legally marketed predicate devices, particularly regarding mechanical performance and material properties. The primary study proving this is Fatigue Testing per ISO 14801:2007, which is a standard for dental implants.

1. Table of Acceptance Criteria (Implicit from Predicate Equivalence) and Reported Device Performance:

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

• Test Set (for Fatigue Testing): The specific number of implants/abutments used in the fatigue test is not explicitly stated as a "sample size" in the document, but it's implied that sufficient samples were tested to demonstrate compliance with ISO 14801:2007.
• Data Provenance: The tests were conducted internally by MIS Implants Technologies Ltd. and by an "independent testing laboratory" for shelf-life testing. The country of origin for the data is not explicitly stated beyond Israel (MIS Implants Technologies Ltd. is based in Israel) for the company and general international standards for the testing. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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

• N/A. This information is relevant for studies involving human interpretation or clinical outcomes for AI/ML devices. For a physical device demonstrating mechanical and material properties, "ground truth" is established by adherence to recognized international standards (e.g., ISO for mechanical testing, AAMI/ISO for sterilization), and expert judgment is inherent in the development and validation of these standards, not typically in individual "readers" of test results.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods (like 2+1, 3+1) are primarily used in clinical studies or expert review processes for AI/ML performance evaluation. For mechanical and sterilization testing, the "adjudication" is the pass/fail result based on the quantitative measurements against the standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is specific to evaluating the clinical effectiveness of a diagnostic tool (often imagery-based) with and without AI assistance, involving multiple human readers. This document is for a physical dental implant.

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

• No. This question applies to AI/ML algorithms. The performance assessment here is for the physical device itself (mechanical, material properties).

7. The Type of Ground Truth Used:

• For mechanical and physical properties (fatigue, material composition, sterility, shelf-life), the "ground truth" is adherence to established international standards and engineering specifications (e.g., ISO 14801:2007, ASTM F136-13, ANSI/AAMI/ISO 11137-1:06, EN ISO 11137-2:12, ISO 17665-1:2006, ISO 14971). Pathological or outcomes data (clinical ground truth) was not required for this 510(k) as per section 9.

8. The Sample Size for the Training Set:

• N/A. This term is relevant for AI/ML models. This is a physical device.

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

• N/A. This term is relevant for AI/ML models.

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MIS Conical Connection Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

The conical connection dental implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:

0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

The implants surface is sand blasted and acid etched.

The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.

The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.

This looks like information from a 510(k) premarket notification for a medical device, specifically dental implants. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through clinical trials that would typically involve acceptance criteria and detailed performance studies like those common for PMAs or de novo submissions.

Therefore, many of the requested categories (like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set") are not applicable in the context of this 510(k) submission.

The document focuses on comparing the new device to a legally marketed predicate device based on technological characteristics and non-clinical performance (like fatigue testing), with a brief mention of a preliminary clinical evaluation for stability.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

Not applicable in the typical sense for a 510(k) submission. The "acceptance criteria" here is "substantial equivalence" to the predicate device. The performance is demonstrated through a comparison of technological characteristics and non-clinical testing.

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:
  • Non-clinical (Fatigue Test): Not explicitly stated. Typically, fatigue tests follow ISO or ASTM standards, which specify sample sizes (e.g., 5-10 samples per group).
  • Clinical Evaluation: "case studies" - the specific number of cases is not stated, but "case studies" typically implies a small number.
• Data Provenance: Not specified for the non-clinical or preliminary clinical evaluation. Israel, where the company is located, is the likely origin for the internal testing.
• Retrospective or Prospective:
  • Non-clinical: Likely prospective (tests conducted specifically for this submission).
  • Clinical Evaluation: "preliminary clinical evaluation, based on case studies with six months follow up" suggests prospective observation of a small number of patients post-implantation.

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. For a device like this, the "ground truth" for the non-clinical fatigue test is measured physical parameters, not expert consensus on images. The preliminary clinical evaluation likely involved clinical observations made by the treating clinicians, not multiple independent experts establishing a "ground truth" for a test set in the same way as, for example, a diagnostic AI device.

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

Not applicable. No expert adjudication method is described for either the non-clinical or preliminary clinical evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI diagnostic device.

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

Not applicable. This device is not an AI diagnostic device/algorithm.

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

• Non-clinical Fatigue Test: The ground truth is the physical measurement of fatigue properties (e.g., cycles to failure, maximum load) according to established engineering standards.
• Preliminary Clinical Evaluation: The "good stability" observation would be based on clinical outcomes and examinations by the treating clinician over the six-month follow-up period.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

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PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours. The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.

The provided 510(k) summary for the PerioPatch does not contain information regarding objective acceptance criteria or a study designed to demonstrate device performance against such criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for 510(k) clearances. Substantial equivalence is determined by comparing the new device to a legally marketed predicate device based on intended use, technological characteristics, and performance. In this case, the performance aspect is described in general terms, highlighting the similar hydrophilic characteristics and self-adhesive nature upon contact with moisture.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available in the document:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
• Sample size used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any quantitative testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant in an application focused on substantial equivalence through comparison of characteristics rather than a new performance study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or clinical study is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This concept is entirely irrelevant to a wound dressing device described here.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study was conducted.
• The sample size for the training set: Not applicable as this is not an AI/ML device, and no training data for a model is mentioned.
• How the ground truth for the training set was established: Not applicable.

The conclusion states: "The evaluation of PerioPatch does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device." This indicates that the regulatory decision was made based on the comparison of the device's characteristics and intended use to an existing, cleared device, rather than on new performance studies with objective acceptance criteria.

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