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Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.

Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.

The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.

The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.

The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.

The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.

The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A

All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.

The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.

Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:

Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System

The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.

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

As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.

Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.

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Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.

Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.

The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.

This document is a 510(k) Summary for the Zirconia and Nuvo CF Guided Surgery Kit Cases. It describes the non-clinical performance data used to evaluate the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.

They are intended for single use and provided non-sterilization recommended before installation in the mouth.

All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.

The provided text describes the Neodent Implant System - Custom Abutments, a medical device. This product is not an AI/ML device, and therefore does not have acceptance criteria or a study that proves the device meets those criteria in the way requested in the prompt.

The document discusses the substantial equivalence of the Neodent Implant System - Custom Abutments to legally marketed predicate devices, which is the basis for its 510(k) clearance by the FDA. The performance testing section describes bench tests (dynamic fatigue and torsion tests), sterilization validation, MR compatibility testing, and biocompatibility testing. These tests evaluate the physical, chemical, and biological properties of the device, comparing them to established standards and predicate devices to demonstrate equivalence, not to meet a set of acceptance criteria for an AI/ML algorithm's performance.

Because the device is not an AI/ML device, the specific information requested about acceptance criteria for AI performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established is not applicable and is not present in the provided text.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. Healing,

The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The Zirconia Abutments subject of this submission are similar to devices already approved in previous submissions of Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Zirconia Abutments with new dimensions of gingival height for Zirconia Healing Abutments, Zirconia Bases, CR Abutments for Zirconia and PEEK CR Abutments for Zirconia, to provide more treatment options to the customers. All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method. The new transmucosal heights are 3.5mm and 4.5mm.

The restorative materials Polycon ae, N!ce and IPS e.max CAD LT were not presented in previous submissions of Zirconia Implant System and are being included in the scope of Zirconia Bases indication.

The provided document is a 510(k) summary for the Neodent Implant System - Zirconia Implant System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and expert adjudication as might be seen for novel AI/software as a medical device (SaMD) products.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods for training sets.

The performance testing section (pages 14-15) describes:

• Bench Testing:
  • Dynamic fatigue testing: Conducted according to FDA guidance and ISO 14801. The results demonstrated the subject devices do not introduce a new worst case compared to predicate and reference devices.
  • Torsion tests: Performed to evaluate screw strength, and results proved adequate torsion strength according to installation torque.
• Biocompatibility Testing:
  • Assessment performed according to ISO 10993-1 and FDA guidance. No new issues were raised and no additional testing was required because the subject devices are identical in material and manufacturing processes to predicate and reference devices.
• Sterilization Validation and Packaging:
  • Ethylene Oxide (EO) sterilization validated to SAL of 10-6 per ISO 11135:2014. EO residuals verified per ISO 10993-7. The packaging and sterilization are identical to predicate devices.
  • Steam sterilization validated per ISO 17665-1, using parameters identical to predicate devices.
  • Pyrogen limit specifications met via LAL Endotoxin Analysis (testing limit 20 EU/device) for blood contacting and implanted devices.

In essence, the study presented is a non-inferiority or equivalence-based assessment against previously cleared devices, focusing on engineering and biocompatibility characteristics, not clinical performance metrics or AI algorithm validation metrics.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document describes a traditional medical device (dental implants and abutments) clearance, not a software or AI device that would have the specific performance study criteria outlined in your request.

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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, is intended to be surgically placed in the bone of the upper or lower jaw, to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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Indications for Use for Neodent Complement Kit Cases:

Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.

The provided text is a 510(k) summary for a medical device (Complement Kit Cases), focusing on the device's substantial equivalence to a predicate device. It details non-clinical performance data.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.

Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.

The provided document is a 510(k) Premarket Notification for a medical device (Neodent Implant System - Helix NGM Compact Surgical Kit Cases). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study with primary and secondary endpoints often seen in drug trials or some Class III device PMAs.

Therefore, the "acceptance criteria" here refer to the performance standards the device must meet to demonstrate substantial equivalence to its predicate for its stated indications for use, primarily regarding sterilization and reusability. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's the breakdown based on your request, using the information available in the provided FDA document:

1. Table of Acceptance Criteria and Reported Device Performance

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