The SIS Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and is intended for one-time use.

Device Description

The SIS Inguinal Hernia Repair Graft is a flat sheet constructed of an animal sourced bioabsorbable, extracellular matrix collagen membrane derived from porcine Small Intestinal Submucosa, (SIS). It is intended for soft tissue repair with sizes and shapes appropriate for the repair of inguinal hernias. SIS Inguinal Hernia Repair Graft contains collagens I, III, IV and VI. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

AI/ML Overview

The provided document describes the Cook Biotech Incorporated's SIS Inguinal Hernia Repair Graft (K142887) and its substantial equivalence to predicate devices, supported by biocompatibility, mechanical, and clinical testing. The document does not describe the conventional acceptance criteria and device performance in the way typically seen for AI/ML-enabled devices, but rather focuses on demonstrating the device's safety and effectiveness compared to existing market devices.

However, I can extract the relevant performance data from the clinical studies to present it in a similar structure:

1. Table of "Acceptance Criteria" (represented by clinical outcomes) and Reported Device Performance:

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is not defined as specific performance metrics and thresholds like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established through demonstrating that the device is as safe and effective as predicate devices, often using clinical outcomes like recurrence rates and adverse events. Below, I've summarized the key clinical outcomes from the provided studies.

Clinical Outcome (Proxy for Acceptance Criteria)	SIS Inguinal Hernia Repair Graft (SIHRG) Performance	Comparator (Polypropylene Mesh - PP) Performance	Comments
Hernia Recurrence Rate (1-year, US Study)	6.7% (3/45 patients)	0% (0/50 patients)	SIHRG showed a higher recurrence rate at 1 year in the US study. Authors note factors other than device performance (e.g., surgical approach, experience) could influence outcomes.
Hernia Recurrence Rate (3-year, US Study)	15.6% (7/45 patients)	4.0% (2/50 patients)	(Unpublished/unvalidated at the time of submission) SIHRG showed a higher recurrence rate at 3 years in the US study.
Hernia Recurrence Rate (1-year, OUS Study 1)	0% (0/15 patients)	0% (0/15 patients)	OUS studies found no recurrence for SIHRG at 1 year. The difference in recurrence rates between US and OUS studies may reflect differences in surgical procedures.
Hernia Recurrence Rate (3-year, OUS Study 2)	0% (0/35 patients)	2.9% (1/35 patients)	OUS studies found no recurrence for SIHRG at 3 years.
Chronic Pain (6 months, OUS Study 2)	11%	31%	SIHRG showed lower chronic pain.
Chronic Pain (12 months, OUS Study 2)	8%	23%	SIHRG showed lower chronic pain.
Chronic Pain (36 months, OUS Study 2)	3%	14%	SIHRG showed lower chronic pain.
Post-operative Pain (1 year, US Study)	4%	6%	Persistent pain trended higher in the PP group.
Hematoma (US Study)	13% (6/45 patients)	2% (1/50 patients)	SIHRG showed a higher rate of hematoma in the US study.
Seroma (US Study)	11% (5/45 patients)	0% (0/50 patients)	SIHRG showed a higher rate of seroma in the US study.
Biocompatibility	Meets ISO 10993-1 requirements	N/A (implied by predicate status)	Genotoxicity, hemolysis, cytotoxicity, muscle implantation, intracutaneous reactivity, sensitization, systemic toxicity, pyrogenicity, LAL endotoxin.
Mechanical Strength	Adequate for application	N/A (implied by predicate status)	Suture retention strength, burst strength, tensile strength demonstrated adequate mechanical properties.

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

US Randomized Clinical Trial (Bochicchio GV, et al., 2014):
- Sample Size: 95 male patients (45 SIHRG, 50 Polypropylene). Originally 100 randomized, but 5 in SIHM group withdrawn.
- Data Provenance: United States (one center, Baltimore VA hospital).
- Retrospective/Prospective: Prospective (randomized double-blinded trial).
OUS Randomized Clinical Investigation 1 (Puccio F, et al., 2005):
- Sample Size: 45 patients (randomized into Polypropylene, Polyglactin, and SIHRG groups, specific breakdown for SIHRG not explicitly stated, but outcomes for SIHRG are reported).
- Data Provenance: Outside US (1 OUS Center).
- Retrospective/Prospective: Prospective (randomized clinical investigation).
OUS Randomized Clinical Investigation 2 (Ansaloni L, et al., 2009):
- Sample Size: 70 patients (randomized to Polypropylene or SIHRG).
- Data Provenance: Outside US (1 OUS Center).
- Retrospective/Prospective: Prospective (randomized controlled trial).

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

For surgical mesh devices, "ground truth" for clinical outcomes (like recurrence) is established through medical diagnosis during patient follow-up, which involves surgeons, physicians, and possibly imaging specialists evaluating patients post-surgery.
Bochicchio GV, et al. (US Study): "7 investigators including 4 surgeons." The qualifications of these specific surgeons (e.g., years of experience, subspecialty) are not detailed beyond their role.
Puccio F, et al. (OUS Study 1): "5 investigators." No specific qualifications provided.
Ansaloni L, et al. (OUS Study 2): "2 investigators." No specific qualifications provided.

4. Adjudication Method:

The document does not explicitly state an "adjudication method" in the context of resolving discrepancies in diagnoses, as would be common for image-based AI studies. Instead, clinical outcomes (recurrence, pain, adverse events) were recorded by investigators as part of the study protocol. The double-blinded nature of the US study (Bochicchio et al.) for a year could imply a degree of objective assessment, but details on how conflicting diagnoses of recurrence were handled are not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic systems, particularly AI-enabled ones, where multiple readers interpret cases with and without AI assistance. The studies presented here are clinical trials comparing a medical device (surgical mesh) with a comparator (another mesh) for treatment effectiveness and safety outcomes in patients.

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

Not applicable. The device is a surgical implant (mesh), not an algorithm or diagnostic software. Therefore, there is no "standalone performance" in the context of AI. The performance is the device's clinical outcome when implanted in patients by surgeons.

7. The Type of Ground Truth Used:

The ground truth for the clinical outcomes (e.g., hernia recurrence, pain, adverse events) was established by clinical assessment and follow-up data from the patients in the respective studies. This includes:

Physical examination by clinicians.
Patient-reported outcomes (e.g., pain surveys).
Diagnostic imaging (e.g., ultrasound in Puccio F, et al. study for prosthesis visibility).
Medical records and direct observation of adverse events.

8. The Sample Size for the Training Set:

Not applicable for a traditional medical device. The SIS Inguinal Hernia Repair Graft is a physical implant, not an AI/ML model that requires a training set. Its development and testing involve engineering, biocompatibility, and clinical studies, rather than machine learning training.

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

Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 1, 2015

Cook Biotech Incorporated Mr. Perry W. Guinn Vice President/Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K142887

Trade/Device Name: SIS Inguinal Hernia Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: September 10, 2015 Received: September 11, 2015

Dear Mr. Guinn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and

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809]); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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510(k) Summary

Sep. 30, 2015

Cook Biotech Incorporated

SIS Inguinal Hernia Repair Graft

Manufacturer Name: Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709 Official Contact: Perry W. Guinn

DEVICE NAME AND CLASSIFICATION:

Trade/Proprietary Name:	SIS Inguinal Hernia Repair Graft
Common Name:	Surgical graft
Classification Regulations:	Class II, 21 CFR §878.3300 (FTM)

INTENDED USE:

DEVICE DESCRIPTION:

EQUIVALENCE TO MARKETED DEVICES:

The SIS Inguinal Hernia Repair Graft is similar with respect to intended use, materials and technological characteristics to its predicate devices in terms of section 510(k) Substantial Equivalence, as shown in pre-clinical (biocompatibility, conducted in accordance to ISO 10993-1 standards), mechanical, and clinical testing.

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Biocompatibility Testing

The following biocompatibility tests were performed on sterilized SIS devices, which are identical in composition to the SIS Inguinal Hernia Repair Graft (according to the ISO 10993-1 standard):

Genotoxicity
Direct contact in vitro hemolysis
Cytotoxicity ●
Muscle implantation
Acute intracutaneous reactivity
ISO Sensitization
Acute systemic toxicity
. Pyrogenicity
LAL endotoxins ●
. Subchronic systemic toxicity

The results of these tests provide evidence that the SIS Inguinal Hernia Repair Graft meets the biocompatibility requirements of the ISO standard.

Mechanical Testing

The SIS Inguinal Hernia Repair Graft material was tested for the following:

Suture retention strength
Burst strength ●
. Tensile strength

The results of the mechanical tests provide evidence that the SIS Inguinal Hernia Repair Graft provides adequate mechanical strength for its application.

Clinical Testing

The SIS Inguinal Hernia Repair Graft (also known as Surgisis Inguinal Hernia Matrix SIHM) was implanted in 95 patients in 3 separate clinical studies and the results were published in 3 peer reviewed articles. The results address the durability of repair with resorbable SIS Inguinal Hernia graft as used for open, tensionless repairs of inguinal hernias. One of the studies was a recent US randomized clinical trial comparing the use of SIS Inguinal Hernia Repair Graft (SIHRG) to polypropylene mesh (PP) using the Lichtenstein hernia repair procedure. This repair included bridging the defect. Results showed hernia recurrence rates of 6.7% (3/45 patients) and 0% (0/50 patients) at 1 year follow-up in the treatment (SIHRG) versus control groups. A difference in hernia recurrence rate was also seen at 3 years with 15.6% (7/45 patients) and 4.0% (2/50 patients) for the SIHRG and PP groups, respectively* . In addition, post-operative pain was assessed with a 1 year follow-up. Persistent pain trended higher in the PP group (6% vs. 4%). Authors of the U.S. study note that factors other than device performance could influence hernia recurrence outcomes, e.g., surgical approach, surgical experience, etc.

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Two OUS prospectively randomized clinical investigations were conducted comparing SIHRG to PP using the Lichtenstein Repair. These studies found no hernia recurrences for SIHRG-treated patients at 1 and 3 years, (0/15, 1 year)2 and 0% (0/35, 3 years) 3, respectively. Recurrence rates for the PP-treated group found hernia recurrences of 0% (0/15, 1 year)2 and 2.9% (1/35, 3 years) 3. Both studies found lower post-operative pain and discomfort in the SIHRG patients at 30 days 2. The reported differences regarding hernia recurrence between the OUS and US clinical investigations may be reflective of many factors, chief among these being the probable difference in surgical procedures.

In clinical studies in which SIHRG was used to repair an inguinal hernia, the mean BMI in patients undergoing inguinal herniorraphy was 26 kg/m². Recurrence rates may be higher in obese patients (BMI>30) when using SIHRG in a tensionless inguinal hernia repair. A synopsis of each study is presented in the following tables.

*Three year follow-up data not yet validated or published.

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Number of centers	One center; Baltimore VA hospital; 7 investigators including 4 surgeons
Number of patients	100 male patients randomized in a 1:1 fashion to openLichtenstein repair of the test groups, Surgisis InguinalHernia Matrix (SIHM) and control polypropylene mesh:50:50 patientsNote: In SIHM group 5 patients were withdrawn prior tosurgery due to emergency surgery or traumatic eventresulting in 45:50 patients
Study inclusion/exclusioncriteria	Exclusion Criteria: life expectancy<3 years, ASA class IVand V, bowel obstruction, strangulation, peritonitis, bowelperforation, local or systemic infection, history of inguinalhernia repair with meshInclusion Criteria: 18 years of age or older, unilateralhernia, able to provide informed consent.
Patient Age, BMI and HerniaTypes	All male patientsMean Age: 64(24-85) SIHM and 59 (25-97) PolypropyleneBMI: 36(18-39) SIHM; 25(19-37) PolypropyleneHernia type: Direct 20 (44% SIHM) 21(42%Polypropylene)Indirect 26(58% SIHM) 29 (58%Polypropylene)Sliding 24 (53% SIHM) 19 (38%Polypropylene)Non-sliding 26 (58% SIHM) 31 (62%Polypropylene)
Operative procedure specifics -anesthesia, duration ofprocedure	Lichtenstein open repairAnesthesia: Spinal: 4 (9% SIHM) 6 (12% Polypropylene)General: 42 (93% SIHM) 44 (88%Polypropylene)Procedure time (Minutes):134 (SIHM) 115 (Polypropylene)
Patient duration of follow-upoutcomes/adverse events	All patients were followed up for 12 months
	Recurrences:
	3 hernia recurrences all in the SIHM group incidence6.7% vs 0% in Polypropylene group
	All recurrences occurred in patients who originally haddirect inguinal hernias (recurrence rate in subset ofpatients with direct hernias: 3/20 or 15% at 1 year)
	Unpublished 3 year data recurrence rates: 15.6%(7/45) SIHM vs 4% (2/50) Polypropylene
	Post-operative pain:
	At 2 weeks : 9 (20% SIHM) vs 8 (16% Polypropylene)
	At 1 year : 2 (4% SIHM) vs 3 (6% Polypropylene)
	Adverse events:
	Hematoma: 6 (13% SIHM) vs 1 (2% Polypropylene)
	Incisional pain: 2 (4% SIHM) vs 4 (8% Polypropylene)
	Surgical site reaction : 3 (7% SIHM) vs 0 ( 0%Polypropylene)
	Seroma : 5 (11% SIHM) vs 0 (0% Polypropylene)
	Neuralgia: 4 ( 9% SIHM) vs 6 ( 12% Polypropylene )
	Infection: 0 ( 0% SIHM) vs 0 (0% Polypropylene)
	Testicular Problems: 5 (11% SIHM) vs 4 (8%Polypropylene)
	Urinary retention: 6 (13% SIHM) vs 3 (6% Polypropylene)
	Spermatic cord injury: 0 (0% SIHM) vs 1 (2%Polypropylene)
	*One death in SIHM group due to myocardial infarction.

Table 1: Bochicchio GV, et al., Biologic vs Synthetic Inguinal Hernia Repair: 1-Year Results of a Randomized Double-Blinded Trial. J Am Coll Surg 2014; 218:751-759.

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Table 2: Ansaloni L, et al. Inguinal hernia repair with porcine small intestine submucosa: 3year follow-up results of a randomized controlled trial of Lichtenstein's repair with

Number of centers	1 OUS Center / 2 investigators
Number of patients	70 patients randomized to:• Polypropylene• Porcine small intestinal submucosa (Surgisis)
Study inclusion/exclusion criteria	Excluded patients with recurrent hernia, any conditionpreventing a correct evaluation of pain, hypersensitivity todrugs used in study, intraoperative findings of pathologyother than inguinal hernia
Patient Age, BMI and HerniaTypes	Mean age: 61.3 years for polypropylene (SD 17.7 years)56.2 years for SIHM (SD 18.0 years)Mean BMI: 26Mix of direct and indirect inguinal hernias in each group
Operative procedure specifics -anesthesia, duration of procedure	Operative time: SHIM 68.6 Minutes / PP 66.0 MinutesPreoperative antibioticsGeneral or Spinal anesthesia (patient's choice/anesthetist's preference)
Patient duration of follow-upoutcomes/adverse events	36 month follow-up• Hernia recurrence:0% SIHM / 2.9% PP• Chronic pain:6 months 11% SIHM / 31% PP12 months 8% SIHM / 23% PP36 months 3% SIHM / 14% PP• Surgical site occurrence at 1 week post-surgery:Hematoma: 5.7% SIHM / 5.7% PPSeroma: 5.7% SIHM / 17.1% PP

polypropylene mesh versus Surgisis Inguinal Hernia Matrix. Am J Surg 2009; 198:303-312.

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Number of centers	1 OUS Center / 5 investigators
Number of patients	45 patients with unilateral primary inguinal hernia receiving Lichtenstein repair randomized to:• Polypropylene• Polyglactin and polypropylene• Porcine small intestinal submucosa (Surgisis)
Study inclusion/exclusion criteria	Excluded patients with history of major surgery in lower abdomen other than cancer or immune deficiency
Patient Age, BMI and Hernia Types	Mean age 54 (range 26-74 years)Mean BMI 26Mix of direct and indirect inguinal hernias in each group
Operative procedure specifics - anesthesia, duration of procedure	Operative time for all patients 45 minutes (range 35-80 min)Preoperative antibioticsLocal anesthesia
Patient duration of follow-up outcomes/adverse events	12 mo (1-16 mo)All patients received 3 month follow-up, using ultrasound U/S - no evidence of prosthesis in SIS group, prosthesis visible in other groups• Polypropylene – early complications (< 30 days): 1 hematoma, 1 seroma, 1 delayed wound healing, 8 discomfort; late complication (> 30 days) 1 hyperesthesia; hernia recurrence 0• Polyglactin and polypropylene – early complications: 2 hematoma, 1 prolonged pain, 1 sensory loss, 7 discomfort; long term: 1 hyperesthesia, 1 prolonged pain, 1 sensory loss, hernia recurrence 0• Porcine small intestinal submucosa (Surgisis) – early: 1 seroma, 2 discomfort; late – none, hernia recurrence 0

Table 3: Puccio F, et al.. Comparison of three different mesh materials in tension-free hernia repair: Prolene versus Vypro versus Surgisis. Int Surg 2005:90:S21-S23.

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Substantial Equivalence

See Table 4 for a comparison of the subject device and its predicates.

Device	SIS Inguinal HerniaRepair Graft	SurgiMend CollagenMatrix	SIS Hernia RepairDevice
Manufacturer	Cook BiotechIncorporated	TEI Biosciences Inc.	Cook BiotechIncorporated
510(k) Number	K142887	K083898	K062697
Intended Use	For implantation toreinforce soft tissues whereweakness exists, includingthe repair of inguinalhernias.	For implantation toreinforce soft tissuewhere weakness existsand for the surgical repairof damaged or rupturedsoft tissue membranes.SurgiMend is specificallyindicated for: plastic andreconstructive surgery,muscle flapreinforcement, herniarepair includingabdominal, inguinal,femoral, diaphragmatic,scrotal, umbilical, andincisional hernias.	For implantation toreinforce soft tissueswhere weakness exists.Indications for useinclude repair of a herniaor body wall defect.
Product code	FTM	FTM	FTL
21 CFR	878.3300	878.3300	878.3300
Material	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IVand VI collagen(constituents of theextracellular matrix)	Collagen based derivedfrom fetal bovine dermis	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IVand VI collagen(constituents of theextracellular matrix)
Dimensions	Rectangular or pre-shaped6 x 10 cm8 x 15 cm10 x 15 cm12 x 15 cm13 x 18 cm	3 x 3 cm to 20 x 20 cmsquare, 0.3 x 25 cm to 25x 40 cm rectangle, 7 x 17cm to 10 x 20 rectangle,8 x 16 cm to 15 x 15 cmsemi-oval	5 x 8 cm to 20 x 30 cm
Thickness	0.1 - 1.0 mm	0.5 to 4.4 mm	0.1 - 1.5 mm
EtO Sterilized	Yes	Yes	Yes

Table 4 – Substantial Equivalence Comparison

CONCLUSION:

The mechanical, pre-clinical, and clinical tests performed on the SIS Inguinal Hernia Repair Graft show that the device is substantially equivalent to its predicates.

REFERENCES:

1.Bochicchio, GV, et al., J Am Coll Surg, 2014. 218(4): p. 751-7.

2.Puccio, F, et al., Int Surg, 2005. 90(3 Suppl): p. S21-3.
3.Ansaloni, L, et al., Am J Surg, 2009. 198(3): p. 303-12.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.