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The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:

1. Mandibular tumor resection.
2. Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
3. Significant comminuted fractures, including significant bone loss; of the mandible.
4. Intermaxillary fixation without an appropriate external fixation by other means.

The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.

Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors.

Here's an analysis of the provided text regarding the BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical trials for efficacy and safety. Therefore, much of the requested information (like detailed acceptance criteria and standalone study results, detailed ground truth establishment for a training set, or MRMC studies) is generally not found in a 510(k) summary for this type of device. The focus is on demonstrating that the new device is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a bone fixation system, the "acceptance criteria" are primarily related to material specifications, mechanical properties, and equivalence in intended use and operating principles to predicate devices. The document does not explicitly state quantitative "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly "accepted" if found substantially equivalent to the predicate devices.

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

The document does not describe a "test set" in the context of an AI/software algorithm evaluation. Instead, the submission relies on:

• Engineering/Bench Testing: Implied by the discussion of material properties (strength retention, biodegradation). No specific sample sizes for these tests are provided in this summary.
• Comparison to Predicate Devices: The primary "test" is to demonstrate substantial equivalence to previously cleared devices. This involves comparing specifications, intended use, operating principles, and materials. The "sample" in this case is the new device itself, being compared element-by-element to the predicate devices.
• Data Provenance: Not applicable in the context of human data. The "data" here refers to the device's design, material properties, and intended function.

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

Not applicable. This device is a bioabsorbable fixation system, not a diagnostic AI system requiring expert-established ground truth from medical images or patient data. The "ground truth" for this submission is whether the device's characteristics (material, strength, design, intended use) are substantially equivalent to legally marketed predicate devices, which is assessed by the FDA based on the submission's technical details.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there's no expert labeling task described.

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

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a surgical implant designed to stabilize bone, not a diagnostic tool, and therefore an MRMC study is not relevant or described.

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

Yes, in a sense, the evaluation of the device's physical and mechanical properties (material composition, strength retention, biodegradation time) can be considered a "standalone" assessment of the device's intrinsic characteristics. However, this is not an "algorithm-only" standalone performance as typically discussed for AI/software. The device itself (the implant) is the "standalone" subject of the evaluation, separate from its use in a patient (human-in-the-loop). No specific study in this format is detailed beyond the general statements of properties.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices already on the market. The BioSorbFX™ O/M 2.0/2.4 System is deemed safe and effective because it is substantially equivalent to these predicate devices. The factual basis for this substantial equivalence includes:

• Material Science/Engineering Data: Data on the polymer composition, strength, and degradation characteristics.
• Design Specifications: Detailed blueprints and specifications of the plates, screws, and instrument set.
• Previous FDA Clearances: The regulatory history and clearance (510(k) numbers K982139, K982721, K981666, etc.) of the predicate devices serve as the "ground truth" for what is considered safe and effective for this product type.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.

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

Not applicable. No training set is involved.

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The MacroPoreOS Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The MacroPoreOS Protective sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPoreOS Protective Sheet is intended to maintain the relative position weak bony tissue in trauma and reconstructive orthopedic procedures involving:

• · Long bones
• Flat bones
• · Short bones
• · Irregular bones
• · Appendicular skeleton
• · Thorax

When used alone (without traditional rigid fixation), the MacroPoreOS Protective Sheet is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

• · Tumor resections where bone strength has not been compromised
• · Iliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPoreOS Protective Sheet is a resorbable, macroporous implant in sheet form manufactured from polylactic acid (PLA). MacroPoreOS Protective Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPoreOS Protective Sheet to the desired shape or size. MacroPoreOS Protective Sheet is fully malleable when heated to approximately 65℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPoreOS Protective Sheet can be rolled into a tube or used as a flat sheet. MacroPoreOS Protective Sheet can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to further stabilize the anatomical region. The MacroPoreOS System includes MacroPoreOS Protective Sheets, a selection of resorbable MacroSorb Screws, MacroSorb Tacks and associated manual instruments.

MacroPoreOS Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The pore size ranges from 500 microns to 2500 microns in diameter, with pores distributed uniformly throughout the sheet in an offset or aligned pattern. The thickness of the MacroPoreOS Protective Sheet ranges from 0.50 mm to 2.0 mm according to the orthopedic region to be treated, however, not to exceed a total mass of 18 grams.

The MacroPoreOS Protective Sheet is fabricated from polylactic acid (PLA).

Here's an analysis of the acceptance criteria and study information for the MacroPoreOS Protective Sheet (K994158), based on the provided text:

Acceptance Criteria and Device Performance (K994158)

The provided document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria in the same way a clinical trial might. Therefore, the "acceptance criteria" here are largely defined by the characteristics of the predicate device and the mechanical properties deemed equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

• Effect of Heating: Viscosity stayed within appropriate range over 120 minutes at 60°C.
• Accelerated Aging: As rigid and strong as the predicate after simulated 6-month in vivo exposure. Retains strength for 9 months, decreases to zero after approximately 18 months.
• Mechanical Testing: "Determined the MacroPoreOS Protective Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." |
  | Crystallinity: Amorphous (non-crystalline). | "The tests ran on the sterile and non-sterile samples revealed no endothermic spikes. From this we verify the implants are amorphous or non-crystalline." |
  | Resorption: Intended to be metabolized by the body. | "The polymer devices are intended to be metabolized by the body and do not require removal." (Implied by accelerated aging test showing strength decrease over time). |

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

The document does not describe a clinical test set in the traditional sense (e.g., patient data for diagnostic accuracy). The "testing" primarily involved in vitro studies and comparative analysis to predicate devices.

• Sample Size: Not explicitly stated in terms of patient numbers or clinical cases. The samples for in vitro tests would be material samples of the MacroPoreOS Protective Sheet itself.
• Data Provenance: The 'data' are results from laboratory testing (in vitro) performed by the manufacturer, MacroPore, Inc. There is no mention of country of origin for clinical data or whether it was retrospective or prospective, as no human clinical data is presented for this 510(k) submission.

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

Not applicable. No "ground truth" based on expert consensus for clinical cases is mentioned, as this submission relies on demonstrating substantial equivalence through mechanical and material properties, not clinical diagnostic or treatment efficacy data from human subjects.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as point 3.

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

No. This is a 510(k) premarket notification for a Class II bone fixation appliance. It does not involve AI, image interpretation, or a comparative effectiveness study involving human readers.

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

No. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the known, accepted properties and performance of the legally marketed predicate devices (Sofamar Danek Timesh K974017, MacroPore Protective Sheet K972913, MacroPore Protective Sheet K983360) and standard scientific/engineering principles for material characterization and mechanical testing. The MacroPoreOS Protective Sheet's characteristics (material, design, mechanical strength, resorption profile) are compared to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The "training" for the device, if one were to stretch the analogy, would be the research and development process that led to its design, informed by predicate device characteristics.

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

Not applicable, as there's no training set. The "ground truth" for the device's design parameters was established through comparison to legally marketed predicate devices and physical/chemical characterization tests (e.g., DSC for crystallinity, viscosity testing, accelerated aging).

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