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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Magicore Narrow System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. For dental implants, substantial equivalency is typically demonstrated through engineering and material characteristic comparisons to predicate devices, and performance testing, rather than clinical studies with patient outcomes. Therefore, the questions typically associated with clinical studies (like sample size for test sets, number of experts for ground truth, MRMC studies, training set details, etc.) are not directly applicable in the context of this 510(k) summary.

The manufacturer is demonstrating substantial equivalence by comparing the "Magicore Narrow System" to several predicate and reference devices. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on comparative technical characteristics and non-clinical performance testing, rather than a clinical trial with human subjects.

Here's a breakdown based on the provided document, addressing the closest equivalents to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" here refers to demonstrating that the new device's characteristics and performance are substantially equivalent to legally marketed predicate devices, meaning they do not raise new questions of safety or effectiveness. The performance is "reported" by showing that the subject device's features align with or are within acceptable ranges of the predicate devices, and by outlining non-clinical tests performed.

• Inner Connection: Internal hex, non-submerged (similar to predicates).
• Endosseous Implant: Tapered, macro threads (similar to predicates).
• Platform Diameters: Ø 4.0.
• Fixture Diameters: Ø 3.0, Ø 3.5 (similar to predicates, with Ø 3.3 for one predicate and Ø 3.0 for another).
• Implantable Lengths: 11.0, 13.0, 15.0 mm (longer lengths supported by reference device K093321).
• Modified Surface: RBM & SLA (Primary predicate K161244 uses SLA; reference device K093321 uses RBM. Differences justified).
• Surgical Technique: 1 and 2 stage, self-tapping (similar to predicates).
  Abutments: Various abutments (Closing Screw, Short Abutment, Magic Abutment, Magicore Solid Abutment, Magicore Solid Abutment Cap, Magicore Healing Cap, Healing Cap Screw, Abutment Screw) are compared to various reference devices (K152520, K192197, K212517, K201981, K173120). Differences in dimensions (diameters, lengths) are noted but justified as not affecting fundamental functions or safety due to similarity in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials. |
  | Sterilization | Device must be sterile or sterilizable, and sterilization methods must be validated and equivalent to predicate devices. | Fixtures are provided sterile via Gamma sterilization (similar to predicates). Closing Screw and Magicore Healing Cap also Gamma sterilized. Other abutments are provided non-sterile for end-user sterilization, with validation tested to ANSVAAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1 (leveraged from predicate K202479 and K140806). |
  | Biocompatibility | Device materials must be biocompatible. | Biocompatibility testing for fixtures (ISO 10993-1, 3, 5, 6, 10, 11) and abutments made of Titanium ELI (ISO 10993-1, 5, 6, 10) was leveraged from predicates (K140806 & K162099), demonstrating equivalence with same materials and manufacturing processes. |
  | Non-Clinical Performance | Mechanical and packaging integrity must be demonstrated as safe and effective. | Shelf Life: Tested for subject fixtures according to ASTM F1980 (results met criteria).
  LAL Testing: Performed for subject fixtures according to USP (referenced in K140806 & K162099, results met criteria).
  Surface Modification Analysis: Surface roughness, surface composition analysis, and SEM imaging compared between subject (RBM and SLA surfaces) and predicate devices (K152520 and K192197) to demonstrate substantial equivalence.
  MR Environment Condition: Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.
  Fixture Packaging Performance: Human Factors testing (usability evaluation for aseptic presentation per ISO 11607-1:2019 and FDA guidance), low and high magnification imaging after removal from packaging to check for damage, and Quality System plan for packaging acceptance activities were provided. Results indicated devices conform to product specifications with packaging design. |

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

This document is a 510(k) summary for a dental implant, which does not typically involve a "test set" or "training set" of patient data in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through comparative engineering data and non-clinical performance testing.

• Sample Size for Testing: The document refers to various standards (e.g., ASTM F1980, ISO 11137-1/2, USP , ANSV/AAMI ST79 series, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1, ISO 10993 series) for non-clinical performance tests. The specific sample sizes for these engineering tests are not detailed in this summary but would be part of the full test reports. For example, biomechanical tests (fatigue, static strength) are typically conducted with small sample sizes (e.g., n=5 or n=10 per group, as per ISO standards for implants).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (InnoBioSurg Co., Ltd.) or leveraged from testing performed for predicate devices from other manufacturers. Data is implicitly prospective in the sense that the manufacturer conducted these tests for this specific submission or leveraged existing valid test data from similar devices. The country of origin for the non-clinical data is not specified but the manufacturer is based in the Republic of Korea.

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

Not applicable. "Ground truth" in the context of clinical expert consensus for image-based diagnostic or prognostic devices is not relevant for this type of medical device (dental implant). Substantial equivalence is based on engineering and material standards, and comparison to already-cleared predicate devices. The "experts" would be the engineers and quality assurance professionals who conducted and reviewed the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert annotations or diagnoses, as this is not a diagnostic device relying on human interpretation of complex data.

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

No. An MRMC comparative effectiveness study is not performed for dental implants. These studies are typically conducted for AI/ML-driven diagnostic or screening devices to assess how the AI assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm-based diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Compliance with recognized international and national standards for medical devices and dental implants (e.g., ASTM, ISO standards for materials, sterilization, biocompatibility, mechanical properties).
• Predicate Device Equivalence: The established safety and effectiveness of legally marketed predicate devices. The "ground truth" is that if the new device is sufficiently similar to a predicate device in termsally relevant characteristics (and any differences do not raise new safety/performance questions), then it is considered safe and effective.
• Non-Clinical Test Results: Data from physical, chemical, mechanical, and biological (biocompatibility) tests proving that the device meets specified performance requirements outlined in the relevant standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device requiring data to learn patterns.

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

Not applicable, as there is no training set.

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